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Orlistat

Indications/Dosage

Labeled

  • obesity
  • weight management

Off-Label

    † Off-label indication

    For the treatment of obesity and for chronic weight management as an adjunct to a reduced-calorie diet and lifestyle modification

    Oral dosage (prescription-only product, 120-mg capsules, e.g., Xenical)

    Adults

    1 capsule (120 mg) PO 3 times per day with each main meal containing fat, taken during the meal or up to 1 hour after the meal. If a meal is occasionally missed or contains no fat, the dose of orlistat can be omitted.[27971] Because orlistat may reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, it is recommended patients take a daily multivitamin containing these vitamins at least 2 hours before or after orlistat. The patient should be on a nutritionally balanced, reduced-calorie diet that includes approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals.[27971] INTENDED USE: To promote weight loss and maintenance in obese patients with a BMI 30 kg/m2 or more OR those with a BMI of 27 kg/m2 or more in the presence of at least 1 obesity-related risk factor (e.g., hypertension, diabetes mellitus, or dyslipidemia). Orlistat, when used under optimal conditions at prescription doses, can reduce BMI and weight, and reduces the risk for weight regain in chronic use.[27971] [62880] [62881] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, pharmacotherapy should be offered as chronic treatment along with lifestyle modifications to patients with obesity when the potential benefits outweigh the risks. Short-term pharmacotherapy has not been shown to produce longer-term health benefits and cannot be generally recommended. A generalized hierarchy for medication preferences that would be applicable to all patients cannot currently be scientifically justified. Individualized weight loss pharmacotherapy is recommended, based upon factors such as the specific characteristics of each weight loss medication, the presence of weight-related complications, and the medical history of the patient. Combination therapy should only occur when such therapy is approved by the governing agency or when sufficient safety and efficacy data assure a favorable benefit-to-risk ratio.[62881]

    Children and Adolescents 12 years and older

    1 capsule (120 mg) PO 3 times per day with each main meal containing fat, taken during the meal or up to 1 hour after the meal. If a meal is occasionally missed or contains no fat, the dose of orlistat can be omitted.[27971] Because orlistat may reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, it is recommended patients take a daily multivitamin containing these vitamins at least 2 hours before or after orlistat. The patient should be on a nutritionally balanced, reduced-calorie diet that includes approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals.[27971] [62880] [62881] [58571] [63035] INTENDED USE: To promote weight loss and maintenance in obese patients with a BMI 30 kg/m2 or more OR those with a BMI of 27 kg/m2 or more in the presence of at least 1 obesity-related risk factor (e.g., hypertension, diabetes mellitus, or dyslipidemia). In pediatric patients, pharmacotherapy is usually reserved for pediatric patients with a BMI at the 95th percentile or more or meeting the adult BMI recommendations for use. Pharmacotherapy for overweight children (BMI 85th to 94th percentile) should be reserved for those with significant, severe comorbidities who have not responded to lifestyle modification.[58571] [63035] Orlistat, when used under optimal conditions at prescription doses, can reduce BMI and weight, and reduces the risk for weight regain in chronic use; however, in pediatric patients, adherence at meals (e.g., school days, etc.) may be problematic.[27971] [62880] [62881] [58571] [63035]

    Oral dosage (non-prescription 60 mg capsules, e.g., Alli)

    Adults

    1 capsule (60 mg) PO 3 times per day with each main meal containing fat, taken during the meal or up to 1 hour after the meal. If a meal is occasionally missed or contains no fat, the dose of orlistat can be omitted. Max: 180 mg/day (3 capsules/day) with non-prescription use. Because the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene is reduced, supplement a daily multivitamin containing these vitamins at least 2 hours before or after orlistat.[60877] INTENDED NON-PRESCRIPTION USE: To aid weight loss in overweight adults. The American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines do not specifically address the use of non-prescription weight loss products.[62881]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults <p>360 mg/day PO (Xenical, Rx-only), 180 mg/day PO (Alli, OTC use).</p>
    • Geriatric <p>360 mg/day PO (Xenical, Rx-only), 180 mg/day PO (Alli, OTC use).</p>
    • Adolescents <p>360 mg/day PO (e.g., Xenical, Rx-only); OTC use (e.g., Alli) not recommended.</p>
    • Children <p><em>12 years:</em> 360 mg/day PO (Xenical, Rx-only); OTC use (i.e., Alli) not recommended.</p> <p><em>1 to 11 years:</em> Safety and efficacy have not been established.</p>
    • Infants <p>Not indicated.</p>

    Patients with Hepatic Impairment Dosing

    No dosage adjustments are needed. During treatment, if signs or symptoms of liver injury occur, discontinue treatment.[27971] Some guidelines suggest avoidance of orlistat and other weight-loss medications in patients with severe hepatic disease.[62881]

    Patients with Renal Impairment Dosing

    No dosage adjustments are needed.[27971]

    † Off-label indication
    Revision Date: 01/24/2020, 04:53:10 PM

    References

    27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.58571 - Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102:709-757.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.62880 - Apovian CM, Aronne LJ, Bessesen DH, et al. Endocrine Society. Pharmacological management of obesity: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100:342-362. Epub 2015 Jan 15. Erratum in: J Clin Endocrinol Metab. 2015;100:2135-2136.62881 - Garvey WT, Mechanick JI, Brett EM, et al; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 Suppl 3:1-203.63035 - Greydanus DE, Agana M, Kamboj MK, et al. Pediatric obesity: Current concepts. Dis Mon. 2018;64:98-156. Foreword on p. 97 by Leikin JB.

    How Supplied

    Orlistat Oral capsule

    alli 60mg Capsule Refill Pack (53100-0469) (GlaxoSmithKline Consumer Healthcare) null

    Orlistat Oral capsule

    alli 60mg Capsule Refill Pack (53100-0472) (GlaxoSmithKline Consumer Healthcare) (off market)

    Orlistat Oral capsule

    alli 60mg Capsule Starter Pack (53100-0468) (GlaxoSmithKline Consumer Healthcare) (off market)

    Orlistat Oral capsule

    Xenical 120mg Capsule (00004-0257) (Genentech Inc) (off market)

    Orlistat Oral capsule

    Xenical 120mg Capsule (00004-0256) (Genentech Inc) (off market)

    Orlistat Oral capsule

    Xenical 120mg Capsule (00004-0257) (Genentech Inc) (off market)

    Orlistat Oral capsule

    Xenical 120mg Capsule (61269-0460) (H2-Pharma, LLC) null

    Orlistat Oral capsule

    Xenical 120mg Capsule (55289-0848) (PD-Rx Pharmaceuticals, Inc.) (off market)

    Description/Classification

    Description

    Orlistat is a gastrointestinal lipase inhibitor. It is used by prescription (Xenical) as an adjunct to lifestyle modifications for weight loss and chronic weight management in adults and pediatric patients 12 years and older.[27971] A low-dose non-prescription product (Alli) is available for overweight adults.[60877] Orlistat can produce a mean weight loss of approximately 4% and can reduce the risk for weight regain in chronic use.[25614] Modification of some cardiovascular risk factors in obese patients after 1 year of treatment have been noted.[25615] Unlike other weight loss medications, orlistat works non-systemically, blocking the absorption of dietary fat. The non-systemic action of orlistat can be beneficial in obese patients with conditions such as cardiovascular disease, renal disease, or substance abuse; however, treatment is associated with significant gastrointestinal side effects (loose/oily stools, flatulence, fecal urgency) that can affect treatment adherence, limiting the utility of the drug for chronic weight management. Because orlistat reduces the absorption of fat-soluble vitamins, a daily multivitamin containing fat-soluble vitamins (i.e., vitamins A,D,E,K) is recommended during therapy. According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, weight loss medications should be offered as chronic treatment along with lifestyle modifications to patients with obesity when the potential benefits outweigh the risks. Short-term pharmacotherapy has not been shown to produce longer-term health benefits and cannot be generally recommended. A generalized heirarchy for medication preferences that would be applicable to all obese patients cannot currently be scientifically justified. Individualized weight loss pharmacotherapy is recommended, based upon factors such as the specific characteristics of each weight loss medication, the presence of weight-related complications, and the medical history of the patient.[62881] In pediatric patients, orlistat remains the only FDA-approved medication for weight loss; pharmacotherapy is usually reserved for pediatric patients with a BMI at the 95th percentile or more. Pharmacotherapy for overweight children (BMI 85th to 94th percentile) should be reserved for those with significant, severe comorbidities who have not responded to lifestyle modification.[58571][63035] Orlistat was initially approved by the FDA in 1999 as a prescription product; the reduced-dose non-prescription status was attained in 2007.

    Classifications

    • Alimentary Tract and Metabolism
      • Antiobesity Agents, Excluding Dietetics
        • Peripherally-Acting Antiobesity Agents
    Revision Date: 12/27/2018, 01:04:29 PM

    References

    25614 - Sjostrom L, Rissanen A, Andersen T, et al. Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European multicentre orlistat group. Lancet 1998;352:167-72.25615 - Zavoral JH. Treatment with orlistat reduces cardiovascular risk in obese patients. J Hypertens 1998;16:2013-7.27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.58571 - Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102:709-757.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.62881 - Garvey WT, Mechanick JI, Brett EM, et al; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 Suppl 3:1-203.63035 - Greydanus DE, Agana M, Kamboj MK, et al. Pediatric obesity: Current concepts. Dis Mon. 2018;64:98-156. Foreword on p. 97 by Leikin JB.

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Oral Administration

    • Administer with each main meal containing fat; can be administered up to 1 hour after the meal. Patients should be on a reduced-calorie diet with approximately 30% of the calories from fat. Protein, carbohydrate, and fat intake should be balanced over 3 main meals.
    • May omit a dose when a meal is missed or if a meal contains no fat.
    • Orlistat decreases the absorption of some fat-soluble vitamins (A, D, E, K) and beta-carotene. To ensure adequate nutrition, patients should take a daily multivitamin supplement that contains these fat-soluble vitamins. Administer the multivitamin at least 2 hours before or after the administration of orlistat. For example, have the patient take the multivitamin once per day at bedtime unless otherwise directed by the prescriber.[27971][60877]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
      Revision Date: 04/09/2018, 10:59:47 AM

      References

      27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.

      Adverse Reactions

      Mild

      • abdominal pain
      • anxiety
      • back pain
      • diarrhea
      • dizziness
      • fatigue
      • fecal urgency
      • flatulence
      • headache
      • hypovitaminosis
      • increased defecation
      • infection
      • maculopapular rash
      • menstrual irregularity
      • musculoskeletal pain
      • myalgia
      • nausea
      • pruritus
      • purpura
      • rash
      • steatorrhea
      • urticaria
      • vomiting

      Moderate

      • bullous rash
      • cholelithiasis
      • depression
      • edema
      • elevated hepatic enzymes
      • fecal incontinence
      • hepatitis
      • hypoglycemia
      • hypothyroidism
      • vaginitis
      • vitamin D deficiency

      Severe

      • anaphylactoid reactions
      • angioedema
      • bronchospasm
      • hepatic failure
      • hepatic necrosis
      • pancreatitis
      • seizures
      • vasculitis

      GI symptoms that occurred at least twice that of placebo in >= 5% of patients taking orlistat during double-blind, placebo-controlled clinical trials include flatulence with discharge (23.9% year 1; 4.4% year 2; placebo roughly 1%), fecal urgency (22.1% year 1; 2.8% year 2; placebo 6.7% year 1), fecal incontinence (7.7% year 1; 1.8% year 2; placebo < 1%), steatorrhea (20% year 1; 6% year 2; placebo 2.9% year 1), oily spotting (26.6% year 1; 4.4% year 2; placebo roughly 1%), oily evacuation (12% year 1; 2.3% year 2; placebo < 1%) and increased defecation (10.8% year 1; 2.6% year 2; placebo 4.1% year 1). These and other commonly observed adverse effects were usually mild to moderate with approximately 50% lasting for less than one week. At least 1 GI event occurred in 79% of patients in the orlistat group compared to 59% in the placebo group. During the first year of trials, the dropout rate due to adverse effects, primarily steatorrhea, was significantly higher for orlistat (9.1%) compared to placebo (4%) groups. Adverse effects decreased during the second year of study. Overall dropout rates due to adverse effects were similar for both groups over the 2 year period.[25613] Adverse gastrointestinal events associated with orlistat may increase with a diet containing greater than 30% of calories from fat. To prevent exacerbation of GI reactions, patients should adhere to the recommended diet plan while taking orlistat. Psyllium has been reported to be an effective fiber adjunct to reduce some of the GI side effects associated with orlistat.[25613] [27971]

      The following adverse events occurred in >= 2% of patients taking orlistat during the first or second year of double-blind, placebo-controlled clinical trials (and at a percentage rate greater than placebo): abdominal pain (25.5 vs. 21.4% placebo); nausea/vomiting (8.1/3.1% vs. 7.3/3.5% placebo); dizziness (5.2 vs. 5% placebo); infectious diarrhea (5.3 vs. 4.4% placebo); rectal pain (5.2 vs. 4% placebo); gingival disorder (4.1 vs. 2.9% placebo); headache (31 vs. 28% placebo); influenza (39.7 vs. 36.2% placebo); general musculoskeletal pain, such as back pain (13.9 vs. 12.1% placebo), arthritis (5.4 vs. 4.8% placebo), and myalgia (4.2 vs. 3.3% placebo); menstrual irregularity (9.8 vs. 7.5% placebo); fatigue (7.2 vs. 6.4% placebo); pedal edema (2.8 vs. 1.9% placebo); anxiety/depression (2.8/3.4% vs. 2.1/2.5% placebo); rash (unspecified) (4.3 vs. 4% placebo); respiratory tract infection (46 vs. 40% placebo); otitis (4.3 vs. 3.4% placebo); urinary tract infection (5.9 vs. 4.8% placebo); vaginitis (2.6 vs. 1.9% placebo). In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.[27971]

      Low serum levels of beta-carotene and vitamins A, D, and E were observed in a greater percentage of patients receiving orlistat compared to those taking placebo. Actual deficiencies due to hypovitaminosis may be prevented through the use of a daily multivitamin supplement that contains fat-soluble vitamins.[27971]

      An increased risk of cholelithiasis has been associated with rapid and substantial weight loss. In a study investigating the use of orlistat in preventing type 2 diabetes, the rates of cholelithiasis were 2.9% (47/1649) for patients randomized to orlistat and 1.8% (30/1655) for patients randomized to placebo. The increased risk of cholelithiasis was not seen in orlistat trials not evaluating the prevention of type 2 diabetes.[27971] Nevertheless, clinicians should inform patients who take orlistat about this potential risk and instruct them to seek medical attention if they experience severe or prolonged abdominal pain and/or nausea and vomiting.

      In rare cases, leukocytoclastic vasculitis has been reported during post-marketing use of orlistat, with clinical signs including palpable purpura, maculopapular rash, or bullous rash or eruption. Rare post-marketing cases of hypersensitivity reactions have been reported with the use of orlistat. Signs and symptoms have included pruritus, rash (unspecified), urticaria, angioedema, bronchospasm, and anaphylactoid reactions.[27971]

      Cases of elevated hepatic enzymes, increased alkaline phosphatase, exceptional cases of hepatitis, severe liver injury with hepatic necrosis, and acute hepatic failure have been reported during post-marketing use of orlistat. In addition, in August, 2009, the FDA announced that it was reviewing reports of liver-related adverse events associated with the use of prescription and over-the-counter orlistat; after a comprehensive review, the FDA identified 13 total reports of severe liver injury with orlistat. Of the 13 cases, 2 patients died from hepatic failure and 3 patients required liver transplantation. No definite association between liver injury and orlistat has been established. At this time, the FDA advises that healthcare professionals weigh the benefits of weight loss with orlistat against the potential risks when determining if orlistat is appropriate for patients. Patients should report signs and symptoms of liver injury to their health care provider immediately.[40642] [27971]

      Post-marketing cases of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.[27971]

      During post-marketing surveillance, cases of pancreatitis have been reported with the use of orlistat. No causal relationships or plausible mechanisms have been identified to account for this effect in weight-loss therapy.[27971]

      During post-marketing surveillance, hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine. Patients treated with orlistat and levothyroxine should be monitored for changes in thyroid function; orlistat may interfere with the absorption of levothyroxine from the gastrointestinal tract. Administer levothyroxine and orlistat at least 4 hours apart.[27971]

      During post marketing surveillance of orlistat therapy, seizures have been reported in patients treated concomitantly with orlistat and anticonvulsant drugs.[27971]

      Orlistat reduces the absorption of vitamin D and may lead to vitamin D deficiency. Patients should be monitored and supplemented with vitamin D when necessary.[63388]

      Revision Date: 08/01/2018, 03:55:00 PM

      References

      25613 - Davidson M, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: A randomized controlled trial. JAMA 1999;281:235-42.27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.40642 - U.S. Food and Drug Administration. Completed safety review of Xenical/Alli (orlistat) and severe liver injury. Retrieved May 26, 2010. Available on the World Wide Web at http://www.fda.govDrugsDrugSafetyPostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm#DataSummary.63388 - Nutrient-Drug Interactions and Drug-Induced Nutrient Depletions. In: Stargrove MB, Treasure J, McKee DL. Herb, Nutrient, and Drug Interactions: Clinical Implications and Therapeutic Strategies. St. Louis: Mosby Elsevier; 2008:173-831.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • cholestasis
      • malabsorption syndrome
      • pregnancy
      • anorexia nervosa
      • anticoagulant therapy
      • bariatric surgery
      • breast-feeding
      • bulimia nervosa
      • children
      • cholelithiasis
      • diabetes mellitus
      • gallbladder disease
      • geriatric
      • heart failure
      • hepatic disease
      • hepatitis
      • hepatotoxicity
      • human immunodeficiency virus (HIV) infection
      • hypothyroidism
      • infants
      • malnutrition
      • nephrolithiasis
      • organ transplant
      • pancreatitis
      • renal disease
      • renal failure
      • renal impairment
      • schizophrenia
      • seizure disorder

      Orlistat is contraindicated in patients who have demonstrated a hypersensitivity reaction to orlistat or any of the active or inactive ingredients. Rare cases of hypersensitivity reactions have been reported.[27971][60877]

      Orlistat has been shown to decrease nutrient and vitamin absorption; therefore, orlistat is contraindicated for use in patients with chronic malabsorption syndrome. Because orlistat can interfere with the absorption of fat-soluble vitamins, all patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene; the supplement should be taken at least 2 hours before or after orlistat. Orlistat may interact with concomitant drugs, and the clinician is advised to review drug interactions.[27971] [60877]

      Orlistat is contraindicated for use in individuals with cholestasis; patients with a history of gallbladder disease should consult a healthcare provider before use.[27971] [60877] Substantial weight loss can increase the risk of cholelithiasis or gallbladder disease. In a clinical trial of orlistat, the rates of cholelithiasis as an adverse event were 2.9% (47/1649) for patients randomized to orlistat and 1.8% (30/1655) for patients randomized to placebo. The long-term effects on gallstone formation have not been determined; orlistat use does not appear to influence gallbladder motility.[27971] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, close monitoring for cholelithiasis is recommended in patients undergoing weight loss therapy, regardless of modality. Effective preventative measures for obese patients at risk for cholelithiasis include a slower rate of weight loss, increasing/including some dietary fat in the diet (assuming the patient has been on a very low-calorie diet containing little or no fat), or administration of ursodeoxycholic acid. The AACE/ACE Obesity Guidelines also recommend monitoring for pancreatitis due to a proven association between pancreatitis and obesity and reports of pancreatitis occurring in patients receiving orlistat. The drug should be withheld if pancreatitis occurs or the patient has a previous history of pancreatitis.[62881]

      Carefully consider the risk: benefit ratio of using orlistat in patients with hepatic disease. There have been rare postmarketing reports of serious liver injury, hepatotoxicity, and hepatocellular necrosis in patients treated with orlistat by prescription or without a prescription, with some of these cases resulting in acute hepatic failure, liver transplant, or death. Some of these reports involved patients with other potential risks for liver injury. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while taking orlistat. When these symptoms occur, orlistat and other suspect medications should be discontinued immediately and liver function tests (LFTs), including ALT and AST levels, obtained.[27971] [40642] [60877] Orlistat may be best avoided in patients with hepatitis treated with antiretroviral drugs. Loss of virological control has been reported in non-hepatitis patients treated with antiretroviral drugs for human immunodeficiency virus (HIV), and some of these same medications may be used for patients infected with hepatitis or with co-infection with hepatitis.[27971] [60877] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, all weight loss medications should be used cautiously in patients with hepatic impairment and should be avoided in severe hepatic impairment (i.e., Child-Pugh score greater than 9).[62881]

      Use prescription orlistat with caution in patients receiving antiretroviral therapy for human immunodeficiency virus (HIV) infection. Patients with HIV infection should consult with their health care professional before non-prescription use of orlistat. Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs. The exact mechanism for this is unclear but may include inhibition of systemic absorption of the antiretroviral drug. If orlistat use is necessary, frequently monitor the patient's HIV RNA levels. If a confirmed increase in HIV viral load occurs, then orlistat should be discontinued.[27971] [60877]

      Monitor renal function when prescribing orlistat to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis. Some patients may develop increased levels of urinary oxalate following treatment with orlistat, and cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Patients taking orlistat who present with urinary tract pain or with difficulty passing urine may need to be evaluated for the presence of kidney stones.[27971] [60877] The American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines do not recommend use in patients with a history or risk factors for oxalate nephropathy. AACE/ACE Obesity Guidelines consider orlistat a weight reduction option for obese patients with mild to moderate renal impairment (i.e., CrCl 30 to 79 mL/minute). Patients with severe renal disease or impairment (CrCl less than 30 mL/minute) should be monitored closely for oxalate nephropathy if orlistat is used. Orlistat can also be considered in selected patients with end-stage renal failure with a high level of caution.[62881]

      Patients who have undergone an organ transplant must not take nonprescription orlistat, as use may cause interference with medications that prevent transplant rejection. Such patients should use orlistat under prescription only. Prescription use of orlistat should be carefully monitored in such patients. Data from an orlistat and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma concentrations when the drugs are coadministered. Doses of orlistat and cyclosporine must be separated to limit this interaction. More frequent monitoring of cyclosporine concentrations should be considered.[27971] [60877]

      Organic causes of obesity, such as hypothyroidism, should be ruled out prior to prescribing orlistat, and should be treated as per clinical standards of care. Patients treated for hypothyroidism should be aware that orlistat can inhibit the proper absorption of thyroid hormones such as levothyroxine, and doses should be separated to help limit interactions. Thyroid function should be monitored routinely in such patients to ensure euthyroidism is maintained as weight loss efforts are continued.[27971] [60877]

      Use caution when orlistat is used in patients with a concurrent seizure disorder. Patients with a seizure disorder should not use the nonprescription product without healthcare provider approval and monitoring. During postmarketing surveillance of orlistat therapy, seizures have been reported in patients treated concomitantly with orlistat and anticonvulsant drugs, presumably due to an interaction with antiepileptic medications. Review potential drug interactions. Patients should be monitored for possible changes in the frequency and/or severity of convulsions.[27971] [60877] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, orlistat is a preferred weight loss medication in patients with a seizure disorder; many other drugs indicated for weight reduction carry a potential for seizure risk.[62881]

      Weight loss may affect glycemic control in patients with diabetes mellitus. A reduction in dose of oral hypoglycemic medication (e.g., sulfonylureas) or insulin may be required in some patients. Patients with diabetes should be advised to continue to routinely monitor blood glucose and report any changes in blood glucose control to their healthcare provider.[27971] [60877] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, weight loss medications should be considered as an adjunct to lifestyle therapy in all patients with type 2 diabetes mellitus as needed for weight loss sufficient to improve glycemic control, lipids, and blood pressure. During controlled trial evaluation of orlistat as an adjunct to lifestyle therapy versus lifestyle therapy alone for diabetes prevention, a greater weight loss and more profound reductions in incident diabetes occurred with orlistat plus lifestyle therapy than lifestyle therapy alone.[62881]

      Patients who are underweight or who suffer from malnutrition should not use orlistat.[27971] [60877] [62881] Adherence to dietary intake instructions is important in patients taking orlistat. Educate treated patients on the importance of maintaining a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. Generally, the daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals.[27971] [60877] Patients taking orlistat for weight loss or maintenance should be strongly encouraged to take a daily multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat-soluble vitamins (A, D, E, K) and beta-carotene. Also, the levels of vitamin D and beta-carotene may be low in obese patients compared with non-obese subjects. The multivitamin supplement should be taken once a day at least 2 hours before or after the administration of orlistat, such as at bedtime.[27971] [60877] There are insufficient data on the use of orlistat following bariatric surgery.[62881] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, orlistat can be a treatment option along with non-medication interventions (i.e., behavioral/lifestyle program, psychotherapy) in overweight or obese patients with binge eating disorder (BED).[62881] Patients with eating disorders such as anorexia nervosa or bulimia nervosa should not use weight loss medications. The AACE/ACE Obesity Guidelines also consider orlistat a treatment option in obese patients with a substance abuse disorder, including alcoholism, as the drug does not have an addiction or abuse potential.[62881]

      Nonprescription self-use of orlistat is not advised in patients receiving anticoagulant therapy with warfarin; patients are encouraged to discuss the use and receive approval from their health care professionals before using orlistat for weight loss. Vitamin K absorption may be decreased with the use of orlistat. Reports of decreased prothrombin increased INR and unbalanced anticoagulant therapy resulting in a change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and warfarin. More frequent monitoring of the INR or other parameters may be needed in such patients.[27971] [60877]

      According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, orlistat is a preferred weight loss medication for obese patients with existing hypertension, established coronary artery disease, or cardiac arrhythmias; the drug is not associated with adverse cardiovascular effects and does not increase blood pressure or heart rate.[62881] Some trials with orlistat have demonstrated reduction in cardiovascular risk factors, such as lipid profiles and waist circumference in addition to weight reduction.[25613] [25615] Data are insufficient regarding the benefits of the use of orlistat in obese patients with heart failure; the AACE/ACE Obesity Guidelines recommend caution.[62881]

      According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, orlistat may be considered for patients with obesity and depression; however, monitor all patients undergoing weight loss therapy for mood disorders, depression, and suicidal ideation. Evidence assessing safety and efficacy of weight loss medications in patients with a psychotic disorder (e.g., schizophrenia) is insufficient, and the AACE/ACE Obesity Guidelines recommend caution. Patients receiving an antipsychotic should be treated with structured lifestyle modifications to promote weight loss and weight gain prevention; the AACE/ACE Obesity Guidelines suggest that metformin may be beneficial for modest weight loss and metabolic improvements in patients receiving an antipsychotic.[62881]

      Clinical studies of orlistat for weight reduction did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger adults.[27971] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, there are limited data on the use of orlistat for weight reduction in geriatric patients and extra caution is advisable in this population. Geriatric patients selected for weight loss therapy should have structured lifestyle interventions including reduced calorie meal plans and exercise, clear health-related goals including diabetes prevention in high-risk patients with pre-diabetes, blood pressure reduction, and improvements in osteoarthritis, mobility, and physical functioning. Overweight or obese elderly patients being considered for a weight loss medication should be evaluated for osteopenia and sarcopenia.[62881]

      Orlistat is contraindicated for use during pregnancy because weight loss offers no potential benefit to a pregnant woman and weight loss, coupled with reduced absorption of fat-soluble vitamins (A, D, E, K) may result in fetal harm. A minimum weight gain and no weight loss is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy and the need to provide appropriate nutrition to the developing fetus. No embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.[27971] Pregnant women must also avoid nonprescription use of the drug.[60877] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, weight loss medications must not be used during pregnancy. The AACE/ACE Obesity Guidelines recommend that women of childbearing potential receiving orlistat use adequate contraception and discontinue orlistat if pregnancy occurs.[62881]

      The manufacturer recommends caution when administering orlistat to a breast-feeding woman; nonprescription use should be avoided. The minimal systemic bioavailability of orlistat suggests that the drug is not expressed in breast milk; however, it is not known with certainty if orlistat is present in human milk.[27971] [60877] It is not known if the effects of orlistat on maternal availability of fat-soluble vitamins would affect breast milk quality or quantity. Women who are breast-feeding should be encouraged to take proper vitamin supplementation as suggested by orlistat product labeling to avoid deficiencies of fat-soluble vitamins. According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, the use of orlistat in breast-feeding women is generally not recommended.[62881]

      The safety and efficacy of orlistat have not been evaluated in children less than 12 years of age; do not give to infants. Because orlistat may reduce the absorption of certain nutrients essential for proper growth and development, use in children under 12 years of age has not been advised. Use of orlistat in adolescents 12 years and older should be in conjunction with a healthcare professional's approval and prescription. Monitor weight and growth, and, ensure the use of a properly selected multivitamin supplement daily.[27971] Nonprescription use is not advised in pediatric patients as the nonprescription product has been approved only for use in overweight adults.[60877] In pediatric patients 12 years and older, pharmacotherapy is usually reserved for pediatric patients with a BMI at the 95th percentile or more or meeting the adult BMI recommendations for use. Reserve medication therapy for overweight children (BMI 85th to 94th percentile) in those with significant, severe comorbidities who have not responded to lifestyle modification.[58571] [63035] Orlistat can reduce BMI and weight and reduces the risk for weight regain in chronic use; however, in pediatric patients, adherence at meals (e.g., school days, etc.) and side effects may be problematic.[27971] [62880] [62881] [58571] [63035]

      Revision Date: 01/07/2019, 01:50:13 PM

      References

      25613 - Davidson M, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: A randomized controlled trial. JAMA 1999;281:235-42.25615 - Zavoral JH. Treatment with orlistat reduces cardiovascular risk in obese patients. J Hypertens 1998;16:2013-7.27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.40642 - U.S. Food and Drug Administration. Completed safety review of Xenical/Alli (orlistat) and severe liver injury. Retrieved May 26, 2010. Available on the World Wide Web at http://www.fda.govDrugsDrugSafetyPostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm#DataSummary.58571 - Styne DM, Arslanian SA, Connor EL, et al. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017;102:709-757.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.62880 - Apovian CM, Aronne LJ, Bessesen DH, et al. Endocrine Society. Pharmacological management of obesity: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100:342-362. Epub 2015 Jan 15. Erratum in: J Clin Endocrinol Metab. 2015;100:2135-2136.62881 - Garvey WT, Mechanick JI, Brett EM, et al; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 Suppl 3:1-203.63035 - Greydanus DE, Agana M, Kamboj MK, et al. Pediatric obesity: Current concepts. Dis Mon. 2018;64:98-156. Foreword on p. 97 by Leikin JB.

      Mechanism of Action

      Orlistat produces weight loss through inhibition of nutrient absorption. A covalent bond is formed with the active serine residue site of gastric and pancreatic lipases within the lumen of the stomach and the small intestine. As these enzymes become unavailable to hydrolyze dietary triglycerides into free fatty acids and monoglycerides, less fat is absorbed by the body. This results in decreased caloric intake that may result in negative energy balance and weight loss. Therefore, systemic absorption of the drug is not needed to produce a weight-lowering effect. At the recommended therapeutic dose of 120 mg orlistat PO three times per day, dietary fat absorption is inhibited by approximately 30%. Because orlistat may reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, it is recommended patients take a daily multivitamin containing these vitamins during therapy, with the multivitamin supplement taken at least 2 hours before or after the administration orlistat.[27971]

      Revision Date: 04/06/2018, 02:51:22 PM

      References

      27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.

      Pharmacokinetics

      Orlistat is administered orally and has minimal systemic absorption. Sporadic intact amounts of orlistat, low plasma concentration levels (<10 ng/ml), and no evidence of accumulation were observed during therapeutic studies. In vitro, orlistat was > 99% bound to plasma proteins (primarily lipoproteins and albumin) with minimal partitioning into erythrocytes. Metabolism of orlistat to weakly active and inactive metabolites is believed to occur mainly within the gastrointestinal wall. Approximately 83% of a single oral dose of orlistat was excreted unchanged in the feces. Renal excretion was < 2% of the dose. Complete excretion of both urinary and fecal orlistat was reached in 3 to 5 days. The estimated half-life of the absorbed portion of orlistat was approximately 1 to 2 hours.

      Route-Specific Pharmacokinetics

      Oral Route

      Peak plasma concentrations of orlistat (<5 ng/ml) occurred approximately 8 hours after a 360 mg dose. Based on fecal fat measurements, the effect of orlistat may be seen within 24 to 48 hours.

      Revision Date: 02/16/2010, 08:57:44 AM

      Pregnancy/Breast-feeding

      pregnancy

      Orlistat is contraindicated for use during pregnancy because weight loss offers no potential benefit to a pregnant woman and weight loss, coupled with reduced absorption of fat-soluble vitamins (A, D, E, K) may result in fetal harm. A minimum weight gain and no weight loss is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy and the need to provide appropriate nutrition to the developing fetus. No embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.[27971] Pregnant women must also avoid nonprescription use of the drug.[60877] According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, weight loss medications must not be used during pregnancy. The AACE/ACE Obesity Guidelines recommend that women of childbearing potential receiving orlistat use adequate contraception and discontinue orlistat if pregnancy occurs.[62881]

      breast-feeding

      The manufacturer recommends caution when administering orlistat to a breast-feeding woman; nonprescription use should be avoided. The minimal systemic bioavailability of orlistat suggests that the drug is not expressed in breast milk; however, it is not known with certainty if orlistat is present in human milk.[27971] [60877] It is not known if the effects of orlistat on maternal availability of fat-soluble vitamins would affect breast milk quality or quantity. Women who are breast-feeding should be encouraged to take proper vitamin supplementation as suggested by orlistat product labeling to avoid deficiencies of fat-soluble vitamins. According to the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) Obesity Clinical Practice Guidelines, the use of orlistat in breast-feeding women is generally not recommended.[62881]

      Revision Date: 12/27/2018, 03:43:19 PM

      References

      27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.62881 - Garvey WT, Mechanick JI, Brett EM, et al; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 Suppl 3:1-203.

      Interactions

      Level 2 (Major)

      • Amiodarone
      • Amprenavir
      • Atazanavir
      • Atazanavir; Cobicistat
      • Bictegravir; Emtricitabine; Tenofovir Alafenamide
      • Cyclosporine
      • Darunavir
      • Darunavir; Cobicistat
      • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
      • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
      • Delavirdine
      • Doravirine; Lamivudine; Tenofovir disoproxil fumarate
      • Efavirenz
      • Efavirenz; Emtricitabine; Tenofovir
      • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
      • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
      • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
      • Emtricitabine; Rilpivirine; Tenofovir alafenamide
      • Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
      • Emtricitabine; Tenofovir alafenamide
      • Emtricitabine; Tenofovir disoproxil fumarate
      • Etravirine
      • Fosamprenavir
      • Indinavir
      • Lamivudine; Tenofovir Disoproxil Fumarate
      • Lopinavir; Ritonavir
      • Nelfinavir
      • Nevirapine
      • Non-nucleoside reverse transcriptase inhibitors
      • Ombitasvir; Paritaprevir; Ritonavir
      • Propafenone
      • Protease inhibitors
      • Ritonavir
      • Saquinavir
      • Tenofovir Alafenamide
      • Tenofovir Alafenamide
      • Tenofovir, PMPA
      • Tipranavir
      • Triheptanoin

      Level 3 (Moderate)

      • Abacavir
      • Abacavir; Dolutegravir; Lamivudine
      • Abacavir; Lamivudine, 3TC
      • Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
      • Acitretin
      • Apixaban
      • Aspirin, ASA; Pravastatin
      • Bexarotene
      • Cranberry, Vaccinium macrocarpon Ait.
      • Dabigatran
      • Dalteparin
      • Didanosine, ddI
      • Dolutegravir; Lamivudine
      • Edoxaban
      • Emtricitabine
      • Enoxaparin
      • Entecavir
      • Fish Oil, Omega-3 Fatty Acids (Dietary Supplements)
      • Fondaparinux
      • Heparin
      • Isotretinoin
      • Lamivudine, 3TC
      • Lamivudine, 3TC; Zidovudine, ZDV
      • Levothyroxine
      • Levothyroxine; Liothyronine (Porcine)
      • Levothyroxine; Liothyronine (Synthetic)
      • Liothyronine
      • Lorcaserin
      • Nucleoside reverse transcriptase inhibitors
      • Phentermine
      • Phentermine; Topiramate
      • Phytonadione, Vitamin K1
      • Pravastatin
      • Rivaroxaban
      • Stavudine, d4T
      • Telbivudine
      • Thyroid hormones
      • Tinzaparin
      • Tretinoin, ATRA
      • Vitamin A
      • Vitamin D
      • Vitamin D analogs
      • Vitamin E
      • Vitamin E
      • Warfarin
      • Zalcitabine, ddC
      • Zidovudine, ZDV

      Level 4 (Minor)

      • Albiglutide
      • Alogliptin
      • Alogliptin; Metformin
      • Alogliptin; Pioglitazone
      • Alpha-glucosidase Inhibitors
      • Canagliflozin
      • Canagliflozin; Metformin
      • Dapagliflozin
      • Dapagliflozin; Metformin
      • Dapagliflozin; Saxagliptin
      • Dipeptidyl Peptidase-4 Inhibitors
      • Dulaglutide
      • Empagliflozin
      • Empagliflozin; Linagliptin
      • Empagliflozin; Linagliptin; Metformin
      • Empagliflozin; Metformin
      • Ertugliflozin
      • Ertugliflozin; Metformin
      • Ertugliflozin; Sitagliptin
      • Exenatide
      • Glimepiride; Pioglitazone
      • Glimepiride; Rosiglitazone
      • Glipizide; Metformin
      • Glyburide; Metformin
      • Incretin Mimetics
      • Insulin Degludec; Liraglutide
      • Insulin Glargine; Lixisenatide
      • Insulins
      • Linagliptin
      • Linagliptin; Metformin
      • Liraglutide
      • Lixisenatide
      • Meglitinides
      • Metformin
      • Metformin; Pioglitazone
      • Metformin; Repaglinide
      • Metformin; Rosiglitazone
      • Metformin; Saxagliptin
      • Metformin; Sitagliptin
      • Pioglitazone
      • Pramlintide
      • Rosiglitazone
      • Saxagliptin
      • Semaglutide
      • SGLT2 Inhibitors
      • Simvastatin; Sitagliptin
      • Sitagliptin
      • Sulfonylureas
      • Thiazolidinediones
      Abacavir: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Abacavir; Dolutegravir; Lamivudine: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Abacavir; Lamivudine, 3TC: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Abacavir; Lamivudine, 3TC; Zidovudine, ZDV: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Acitretin: (Moderate) Due the effect of orlistat on fat absorption and the lower serum levels of fat-soluble vitamins noted during clinical trials, the bioavailability of acitretin may be decreased. Close monitoring of patients receiving acitretin with orlistat is recommended. [4687] Albiglutide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Alogliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Alogliptin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Alogliptin; Pioglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Alpha-glucosidase Inhibitors: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Amiodarone: (Major) In one pharmacokinetic study of healthy volunteers, administration of orlistat 120 mg three times daily for 13 days and a single orlistat dose of 120 mg on the morning of Day 14 in addition to a single dose of 1200 mg amiodarone on Day 4 resulted in a 23% to 27% reduction in the systemic exposure to amiodarone and its metabolite desethylamiodarone. The effect of initiating treatment with orlistat in patients stable on amiodarone therapy has not been studied; however, a reduced therapeutic effect of amiodarone is possible. The clinical response to amiodarone should be monitored closely if orlistat is initiated during chronic amiodarone therapy. [27971] Amprenavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Apixaban: (Moderate) Patients on chronic stable doses of anticoagulants, like apixaban, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Aspirin, ASA; Pravastatin: (Moderate) Serum concentrations of pravastatin increased by approximately 30% when administered with orlistat in a parallel study of 24 normal-weight, mildly hypercholesterolemic subjects. Orlistat produced additive lipid-lowering effects when used concomittantly with pravastatin. However, another study failed to show any changes in pravastatin pharmacokinetics when coadministered with orlistat. Use caution and monitor patients carefully if using these drugs together. [45507] Atazanavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Atazanavir; Cobicistat: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Bexarotene: (Moderate) Due the effect of orlistat on fat absorption and the lower serum levels of fat-soluble vitamins noted during clinical trials, the bioavailability of orally administered retinoids, such as bexarotene may also be decreased. [4687] Bictegravir; Emtricitabine; Tenofovir Alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Canagliflozin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Canagliflozin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Cranberry, Vaccinium macrocarpon Ait.: (Moderate) Administer vitamin E at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. Orlistat has been shown to inhibit the absorption of a vitamin E acetate supplement by 60%. [27971] Cyclosporine: (Major) Orlistat decreases the absorption of fat by inhibiting gastrointestinal lipases and as cyclosporine is dependent on lipid absorption, especially the Sandimmune formulation, the absorption of cyclosporine is inhibited. Caution is advised with the concomitant use of orlistat and cyclosporine therapy. More frequent cyclosporine concentration monitoring may be needed. To reduce the chance of a drug-drug interaction, cyclosporine should be administered at least 2 hours before or after orlistat in patients taking both drugs; although, as noted, separation of administration times may not always alter the course of the interaction. [4687] [5936] [6803] Dabigatran: (Moderate) Patients on chronic stable doses of anticoagulants, like dabigatran, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Dalteparin: (Moderate) Patients on chronic stable doses of anticoagulants, like dalteparin, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Dapagliflozin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Dapagliflozin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Dapagliflozin; Saxagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Darunavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Darunavir; Cobicistat: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Delavirdine: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Didanosine, ddI: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Dipeptidyl Peptidase-4 Inhibitors: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Dolutegravir; Lamivudine: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Dulaglutide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Edoxaban: (Moderate) Patients on chronic stable doses of anticoagulants like edoxaban should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Efavirenz: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Efavirenz; Emtricitabine; Tenofovir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Empagliflozin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Empagliflozin; Linagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Empagliflozin; Linagliptin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Empagliflozin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Emtricitabine: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Emtricitabine; Tenofovir alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Emtricitabine; Tenofovir disoproxil fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Enoxaparin: (Moderate) Patients on chronic stable doses of anticoagulants, like enoxaparin, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [25618] [27971] [28549] Entecavir: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Ertugliflozin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Ertugliflozin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Ertugliflozin; Sitagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Etravirine: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Exenatide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Fish Oil, Omega-3 Fatty Acids (Dietary Supplements): (Moderate) Administer vitamin E at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. Orlistat has been shown to inhibit the absorption of a vitamin E acetate supplement by 60%. [27971] Fondaparinux: (Moderate) Patients on chronic stable doses of anticoagulants, like fondaparinux, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Fosamprenavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Glimepiride; Pioglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Glimepiride; Rosiglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Glipizide; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Glyburide; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Heparin: (Moderate) Patients on chronic stable doses of anticoagulants, like heparin, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Incretin Mimetics: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Indinavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Insulin Degludec; Liraglutide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Insulin Glargine; Lixisenatide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Insulins: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of insulins or other medicines for diabetes may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Isotretinoin: (Moderate) The bioavailability of orally administered retinoids may be decreased during coadministration with isotretinoin. In patients receiving orally-administered retinoids along with orlistat, close monitoring is recommended. In addition, the manufacturer recommends that fat-soluble vitamin analogues be administered at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. [4687] Lamivudine, 3TC: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Lamivudine, 3TC; Zidovudine, ZDV: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Lamivudine; Tenofovir Disoproxil Fumarate: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Levothyroxine: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of orlistat. Concurrent use may reduce the efficacy of thyroid hormones by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Monitor TSH while orlistat is used concurrently. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine postmarketing. [27971] [28213] [33699] [53562] [60877] Levothyroxine; Liothyronine (Porcine): (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of orlistat. Concurrent use may reduce the efficacy of thyroid hormones by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Monitor TSH while orlistat is used concurrently. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine postmarketing. [27971] [28213] [33699] [53562] [60877] Levothyroxine; Liothyronine (Synthetic): (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of orlistat. Concurrent use may reduce the efficacy of thyroid hormones by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Monitor TSH while orlistat is used concurrently. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine postmarketing. [27971] [28213] [33699] [53562] [60877] Linagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Linagliptin; Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Liothyronine: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of orlistat. Concurrent use may reduce the efficacy of thyroid hormones by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Monitor TSH while orlistat is used concurrently. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine postmarketing. [27971] [28213] [33699] [53562] [60877] Liraglutide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Lixisenatide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Lopinavir; Ritonavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Lorcaserin: (Moderate) The safety and efficacy of coadministration of lorcaserin with other products intended for weight loss including prescription drugs (e.g., phentermine, fenfluramine, dexfenfluramine, orlistat, phendimetrazine, amphetamines), over-the-counter drugs (e.g., orlistat, phenylpropanolamine, ephedrine), and herbal preparations (ephedra, Ma huang) have not been established. Some of these agents (fenfluramine, dexfenfluramine) are known to increase the risk for cardiac valvulopathy and pulmonary hypertension. Co-use of sibutramine with other serotonergic medications is contraindicated due to the risk for serotonin-related adverse effects, such as serotonin syndrome. [51065] [5340] Meglitinides: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin; Pioglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin; Repaglinide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin; Rosiglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin; Saxagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Metformin; Sitagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Nelfinavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Nevirapine: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Non-nucleoside reverse transcriptase inhibitors: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral non-nucleoside reverse transcriptase inhibitors (NNRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Nucleoside reverse transcriptase inhibitors: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Ombitasvir; Paritaprevir; Ritonavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Phentermine: (Moderate) The safety and efficacy of coadministration of phentermine with other products intended for weight loss has not been established. [51256] Phentermine; Topiramate: (Moderate) The safety and efficacy of coadministration of phentermine with other products intended for weight loss has not been established. [51256] Phytonadione, Vitamin K1: (Moderate) Several drugs can interfere with the oral bioavailability of vitamin K including orlistat. In patients receiving orlistat routinely for a prolonged period of time (i.e., more than 2 weeks), vitamin K intake may need to be increased. [4687] Pioglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Pramlintide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of pramlintide or other medicines for diabetes may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Pravastatin: (Moderate) Serum concentrations of pravastatin increased by approximately 30% when administered with orlistat in a parallel study of 24 normal-weight, mildly hypercholesterolemic subjects. Orlistat produced additive lipid-lowering effects when used concomittantly with pravastatin. However, another study failed to show any changes in pravastatin pharmacokinetics when coadministered with orlistat. Use caution and monitor patients carefully if using these drugs together. [45507] Propafenone: (Major) Orlistat may limit the fraction of propafenone available for absorption. In post-marketing reports, abrupt cessation of orlistat in patients stabilized on propafenone therapy has resulted in severe adverse events including convulsions, AV block and acute circulatory failure. [5014] Protease inhibitors: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Ritonavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Rivaroxaban: (Moderate) Patients on chronic stable doses of anticoagulants like rivaroxaban should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [44854] [60877] Rosiglitazone: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Saquinavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Saxagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Semaglutide: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] SGLT2 Inhibitors: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Simvastatin; Sitagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Sitagliptin: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Stavudine, d4T: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Sulfonylureas: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Telbivudine: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Tenofovir Alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Tenofovir Alafenamide: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Tenofovir, PMPA: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with tenofovir, PMPA. Loss of virological control has been reported in HIV-infected patients taking orlistat with tenofovir disoproxil fumarate and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Thiazolidinediones: (Minor) Weight-loss may affect glycemic control in patients with diabetes mellitus. In many patients, glycemic control may improve. A reduction in dose of oral hypoglycemic medications may be required in some patients taking orlistat. Monitor blood glucose and glycemic control and adjust therapy as clinically indicated. [25616] [27971] [60877] [62881] Thyroid hormones: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of orlistat. Concurrent use may reduce the efficacy of thyroid hormones by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Monitor TSH while orlistat is used concurrently. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine postmarketing. [27971] [28213] [33699] [53562] [60877] Tinzaparin: (Moderate) Patients on chronic stable doses of anticoagulants, like tinzaparin, should be monitored closely for changes in coagulation parameters when orlistat is prescribed. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. [27971] [60877] Tipranavir: (Major) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral protease inhibitors. Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Tretinoin, ATRA: (Moderate) The bioavailability of orally administered retinoids may be decreased if coadministered with orlistat. In patients receiving orally-administered retinoids along with orlistat, close monitoring is recommended. In addition, the manufacturer recommends that fat-soluble vitamin analogues be administered at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. [4687] Triheptanoin: (Major) Avoid coadministration of triheptanoin with orlistat. Coadministration with a pancreatic lipase inhibitor, such as orlistat, may reduce exposure to the triheptanoin metabolite, heptanoate, and reduce the efficacy of triheptanoin. [65649] Vitamin A: (Moderate) Due to orlistat's mechanism of action, the potential exists for the malabsorption of drugs and dietary supplements. Patients should be advised to take a multivitamin supplement once per day that contains fat soluble vitamins A, D, E, K and beta-carotene. The manufacturer recommends that fat-soluble vitamin supplements be administered at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. [4687] Vitamin D analogs: (Moderate) Orlistat reduced the absorption of fat-soluble vitamins absorption during clinical trials. The bioavailability of orally administered vitamin D analogs may also be decreased. In patients receiving orally-administered vitamin D analogs along with orlistat, close monitoring is recommended. In addition, the manufacturer recommends that fat-soluble vitamin analogs be administered at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. [27971] Vitamin D: (Moderate) Orlistat reduced the absorption of fat-soluble vitamins during clinical trials. The bioavailability of orally administered vitamin D may also be decreased. In patients receiving orally-administered vitamin D with orlistat, close monitoring is recommended. In addition, the manufacturer recommends that fat-soluble vitamins be administered at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. [27971] Vitamin E: (Moderate) Administer vitamin E at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. Orlistat has been shown to inhibit the absorption of a vitamin E acetate supplement by 60%. [27971] Vitamin E: (Moderate) Administer vitamin E at least 2 hours before or after the administration of orlistat to limit effects on oral absorption. Orlistat has been shown to inhibit the absorption of a vitamin E acetate supplement by 60%. [27971] Warfarin: (Moderate) Warfarin therapy can be affected by changes in dietary intake of vitamin K. Since vitamin K absorption may be affected by orlistat, patients on chronic stable doses of warfarin should be monitored closely for changes in coagulation parameters when orlistat is prescribed; some experts recommend that the INR be monitored weekly during the first month of orlistat therapy. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. Orlistat 120 mg PO 3 times per day administered orally for 16 days in 12 normal-weight subjects did not appear to alter vitamin K nutritional status. No changes in the pharmacokinetics or pharmacodynamics (PT and serum Factor VII) of warfarin were noted following a single 30 mg dose of warfarin in a placebo-controlled, randomized, third-party blind, 2-way crossover study. However, vitamin K levels decreased. [25618] [27971] [28549] [60877] Zalcitabine, ddC: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971] Zidovudine, ZDV: (Moderate) According to the manufacturer of orlistat, HIV RNA levels should be frequently monitored in patients receiving orlistat while being treated for HIV infection with anti-retroviral nucleoside reverse transcriptase inhibitors (NRTIs). Loss of virological control has been reported in HIV-infected patients taking orlistat with atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir; ritonavir, and emtricitabine; efavirenz; tenofovir disoproxil fumarate. The exact mechanism for this interaction is not known, but may involve inhibition of systemic absorption of the anti-retroviral agent. If an increased HIV viral load is confirmed, orlistat should be discontinued. [27971]
      Revision Date: 07/11/2020, 02:27:00 AM

      References

      4687 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.5014 - Rythmol SR (propafenone hydrochloride) capsule extended release package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Nov.5340 - Meridia (sibutramine) package insert. North Chicago, IL: Abbott Laboratories; 2009 Apr.5936 - Sandimmune (cyclosporine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015 Mar.6803 - Zhi J, Moore R, Kanitra L, et al. Pharmacokinetic evaluation of the possible interaction between selected concomitant medications and orlistat at steady state in healthy subjects. J Clin Pharmacol 2002;42:1011-19.25616 - Hollander PA, Elbein SC, Hirsch IB, et al. Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study. Diabetes Care 1998;21:1288-94.25618 - Zhi J, Melia AT, Guerciolini R, et al. The effect of orlistat on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol 1996;36:659-66.27971 - Xenical (orlistat) package insert. South San Francisco, CA: Genentech USA, Inc.; 2016 Jun.28213 - Unithroid (levothyroxine sodium tablets, USP) package insert. Bohemia, NY: Jerome Stevens Pharmaceuticals, Inc.; 2018 Dec.28549 - Coumadin (warfarin tablets) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2017 Aug.33699 - Filippatos TD, Derdemezis CS, Gazi IR, et al. Orlistat-associated adverse effects and drug interactions. A critical review. Drug Saf 2008;31:53-65.44854 - Xarelto (rivaroxaban) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2020 Mar45507 - Pravachol (pravastatin sodium) package insert. Princeton, New Jersey: Bristol-Myers Squibb Company; 2020 Sept.51065 - Belviq and Belviq XR (lorcaserin hydrochloride) package insert. Woodcliff Lake, NJ: Eisai Inc.; 2016 Nov.51256 - Qsymia (phentermine and topiramate extended-release) package insert. Mountain View, CA: Vivus, Inc.; 2020 Sept.53562 - Synthroid (levothyroxine) tablets. North Chicago, IL: AbbVie Inc.; 2020 July.60877 - Alli (orlistat) capsules. Warren, NJ: GSK Consumer Healthcare; 2016 May.62881 - Garvey WT, Mechanick JI, Brett EM, et al; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. American Association of Clinical Endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 Suppl 3:1-203.65649 - Dojolvi (triheptanoin) oral liquid package insert. Novato, CA: Ultragenyx Pharmaceutical Inc.; 2020 Jun.

      Monitoring Parameters

      • growth rate
      • weight

      US Drug Names

      • alli
      • Xenical

      Global Drug names

      Argentina

      • Crisplus - (Elea)
      • Fingras - (Phoenix)
      • Frugal - (Bago)
      • Liposol - (Biotenk)
      • Oleofin - (Casasco)
      • Orlist - (Wunderpharm)
      • Xenical - (Investi)
      • Xeniplus - (Elea)
      • Xinplex - (Craveri)

      Australia

      • Xenical - (Roche)

      Austria

      • Alli - (GSK)
      • Xenical - (Roche)

      Belgium

      • Alli - (GSK Consumer)
      • Xenical - (BePharBel)

      Brazil

      • Lipiblock - (Germed)
      • Lipoxen - (Neo Quimica)
      • Lystate - (Glenmark)
      • Orlax - (Accord)
      • Orlipid - (Sigma)
      • Siluestat - (EMS)
      • Xenical - (Roche)
      • Xenilipe - (Legrand)

      Canada

      • Xenical - (Roche)

      Chile

      • Adell - (Silesia)
      • Liberat - (Laboratorios Chile)
      • Oradiet - (Sanitas)
      • Sagras - (Mintlab)
      • Symfona - (Andromaco)
      • Viplena - (Recalcine)
      • Xenical - (Roche)

      China

      • Xenical - (Roche)

      Czech Republic

      • Alli - (GSK)
      • Xenical - (Roche)

      Denmark

      • Alli - (GSK Consumer)
      • Beacita - (Actavis)
      • Xenical - (Roche)

      Finland

      • Alli - (GSK)
      • Xenical - (Roche)

      France

      • Alli - (GSK Sante)
      • Xenical - (Roche)

      Germany

      • Alli - (GSK Consumer)
      • Xenical - (Roche)

      Greece

      • Alli - (GSK)
      • Xenical - (Roche)

      Hong Kong

      • Alli - (GSK)
      • Aslene - (FP)
      • Cuvarlix - (HealthCare PharmaScience)
      • Optislim - (Sino Pacific)
      • Xenical - (Roche)
      • Zerocal - (Wings)
      • Zerotex - (Kolmar)

      Hungary

      • Alli - (GSK)
      • Beacita - (Actavis)
      • Xenical - (Roche)

      India

      • Cobese - (Ranbaxy)
      • Lipocut - (Biocon)
      • Lipophage - (Franco-Indian)
      • Obelit - (Intas)
      • Obiless - (Solitaire)
      • Obitrol - (Micro)
      • Olisat - (Biocon)
      • Orlica - (Torrent)
      • Orlimac - (Macleods)
      • Orlitroy - (Troikaa)

      Indonesia

      • Obeslim - (Lapi)
      • Xenical - (Roche)

      Ireland

      • Alli - (GSK)
      • Xenical - (Roche)

      Israel

      • Alli - (GSK)
      • Xenical - (Roche)

      Italy

      • Xenical - (Roche)

      Malaysia

      • Aslene - (Xepa-Soul Pattinson)
      • Cuvarlix - (Pharmaniaga)
      • Xenical - (Roche)

      Mexico

      • Amsafast - (Amsa)
      • Andanza - (Medix)
      • Belivag - (Novag)
      • Demolex - (Maver)
      • Enformast - (SBL)
      • Leben-Celtics - (IFA)
      • Lindeza - (Pisa)
      • Lysthin - (Alpharma)
      • Redustat - (Liomont)
      • Slender 1 - (Liomont)
      • Susitax - (Biomep)
      • Talissa - (Apotex)
      • Vasdecom - (Raam)
      • Ventu - (Landsteiner)
      • Xenical - (Roche)

      Netherlands

      • Alli - (GSK Consumer)
      • Xenical - (Roche)

      New Zealand

      • Xenical - (Roche)

      Norway

      • Alli - (GSK)
      • Xenical - (Farmagon)

      Philippines

      • Lesofat - (InnoGen)
      • NoFat - (Square)
      • Obestal - (Stallion)
      • Xenical - (Roche)
      • Xenista - (Geofman)

      Poland

      • Alli - (GSK)
      • Xenical - (Roche)

      Portugal

      • Alli - (GSK)
      • Beacita - (Actavis)
      • Xenical - (Roche)

      Russian Federation

      • Alli - (GSK)
      • Listata - (Izvarino)
      • Orlimax - (Polpharma)
      • Orlixen - (Ozon)
      • Orsoten - (KRKA)
      • Xenalten - (Obolenskoe)
      • Xenical - (Roche)

      Singapore

      • Xenical - (Roche)

      South Africa

      • Xenical - (Roche)

      Spain

      • Alli - (GSK)
      • Beacita - (Aurovitas)
      • Linestat - (Teva)
      • Orlidunn - (Stada)
      • Orliloss - (Sandoz)
      • Xenical - (Roche)

      Sweden

      • Alli - (GSK Consumer)
      • Beacita - (Actavis)
      • Xenical - (Roche)

      Switzerland

      • Alli - (GSK Consumer)
      • Calobalin - (Sandoz)
      • Xenical - (Roche)

      Thailand

      • Xenical - (Roche)

      Turkey

      • Thincal - (Kocak)
      • Wanabi - (Zentiva)
      • Xenical - (Roche)

      Ukraine

      • Orlip - (GM)
      • Xenical - (Roche)

      United Kingdom

      • Alli - (GSK)
      • Xenical - (Roche)

      Venezuela

      • Orlidet - (Klinos)
      • Orlisval - (Valmor)
      • Redicres - (Leti)
      • Redurlat - (Biogalenic)
      • Trimfat - (Farma)
      • Xenical - (Roche)
      • Xerograx - (La Sante)