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    Clofazimine

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    May.29.2024

    Clofazimine

    Indications/Dosage

    Labeled

      Off-Label

      • drug-resistant tuberculosis infection
      • erythema nodosum leprosum (ENL)
      • leprosy (Hansen's disease)
      • tuberculosis infection
      † Off-label indication

      For the treatment of lepromatous leprosy (Hansen's disease)†, including leprosy complicated by erythema nodosum leprosum (ENL)† reactions

      NOTE: Clofazimine is no longer commercially available in the United States. It is available via Investigational New Drug (IND) application; the National Hansen's Disease Program holds the IND for the use of clofazimine in treating Hansen's Disease.[53390]

      for the treatment of susceptible paucibacillary leprosy (Hansen's disease)†

      Oral dosage

      Adults

      50 mg PO once daily plus 300 mg PO once monthly in combination with rifampin and dapsone for 6 months.[63942]

      Adolescents 15 to 17 years

      50 mg PO once daily plus 300 mg PO once monthly in combination with rifampin and dapsone for 6 months.[63942]

      Children and Adolescents 10 to 14 years weighing 40 kg or more

      50 mg PO every other day plus 150 mg PO once monthly in combination with rifampin and dapsone for 6 months.[63942]

      Children and Adolescents 10 to 14 years and weighing less than 40 kg

      50 mg PO twice weekly plus 100 mg PO once monthly in combination with rifampin and dapsone for 6 months.[63942]

      Children 1 to 9 years

      50 mg PO twice weekly plus 100 mg PO once monthly in combination with rifampin and dapsone for 6 months.[63942]

      for the treatment of susceptible multibacillary leprosy (Hansen's disease)†

      Oral dosage

      Adults

      50 mg PO once daily in combination with rifampin and dapsone for 24 months.[53390] Alternatively, 50 mg PO once daily plus 300 mg PO once monthly in combination with rifampin and dapsone for 12 months.[63942] The shorter duration of therapy recommendation is mainly due to WHO's considerations for developing countries; longer duration of treatment is preferred.[53390] [63942]

      Adolescents 15 to 17 years

      1 mg/kg/dose PO once daily or 2 mg/kg/dose PO every other day (Max: 50 mg/day) in combination with rifampin and dapsone for 24 months. Round dose to nearest 50 mg as there is no formulation less than 50 mg and the capsule may not be opened.[53390] Alternatively, 50 mg PO once daily plus 300 mg PO once monthly in combination with rifampin and dapsone for 12 months.[63942] The shorter duration of therapy recommendation is mainly due to WHO's considerations for developing countries; longer duration of treatment is preferred.[53390] [63942]

      Children and Adolescents 10 to 14 years weighing 40 kg or more

      1 mg/kg/dose PO once daily or 2 mg/kg/dose PO every other day (Max: 50 mg/day) in combination with rifampin and dapsone for 24 months. Round dose to nearest 50 mg as there is no formulation less than 50 mg and the capsule may not be opened.[53390] Alternatively, 50 mg PO every other day plus 150 mg PO once monthly in combination with rifampin and dapsone for 12 months.[63942] The shorter duration of therapy recommendation is mainly due to WHO's considerations for developing countries; longer duration of treatment is preferred.[53390] [63942]

      Children and Adolescents 10 to 14 years and weighing less than 40 kg

      1 mg/kg/dose PO once daily or 2 mg/kg/dose PO every other day (Max: 50 mg/day) in combination with rifampin and dapsone for 24 months. Round dose to nearest 50 mg as there is no formulation less than 50 mg and the capsule may not be opened.[53390] Alternatively, 50 mg PO twice weekly plus 100 mg PO once monthly in combination with rifampin and dapsone for 12 months.[63942] The shorter duration of therapy recommendation is mainly due to WHO's considerations for developing countries; longer duration of treatment is preferred.[53390] [63942]

      Children 1 to 9 years

      1 mg/kg/dose PO once daily or 2 mg/kg/dose PO every other day (Max: 50 mg/day) in combination with rifampin and dapsone for 24 months. Round dose to nearest 50 mg as there is no formulation less than 50 mg and the capsule may not be opened.[53390] Alternatively, 50 mg PO twice weekly plus 100 mg PO once monthly in combination with rifampin and dapsone for 12 months for multibacillary disease is recommended by the WHO.[63942] The shorter duration of therapy recommendation is mainly due to WHO's considerations for developing countries; longer duration of treatment is preferred.[53390] [63942]

      for the treatment of dapsone-resistant multibacillary leprosy (Hansen's disease)†

      Oral dosage

      Adults

      100 mg/day PO in combination with 1 or more other antileprosy agents for 3 years, followed by clofazimine 100 mg/day PO monotherapy.[63936]

      for the treatment of rifampin-resistant leprosy (Hansen's disease)†

      Oral dosage

      Adults

      50 mg PO once daily in combination with ofloxacin and minocycline for 6 months, followed by clofazimine in combination with ofloxacin or minocycline for 18 months or ofloxacin and clarithromycin for 6 months, followed by clofazimine in combination with ofloxacin for 18 months. Levofloxacin or moxifloxacin may replace ofloxacin.[63942]

      for the treatment of rifampin- and ofloxacin-resistant leprosy (Hansen's disease)†

      Oral dosage

      Adults

      50 mg PO once daily in combination with clarithromycin and minocycline for 6 months, followed by clofazimine in combination with clarithromycin or minocycline for 18 months.[63942]

      for the treatment of leprosy complicated by erythema nodosum leprosum (ENL)† reactions

      Oral dosage

      Adults

      100 to 200 mg/day PO in combination with baseline antileprosy treatment and steroids as clinically indicated. Give doses above 100 mg/day for the shortest duration possible and only under close medical supervision; taper to 100 mg/day as soon as possible after the reaction is controlled.[63936]

      For the treatment of drug-resistant tuberculosis infection† as part of combination therapy

      Oral dosage

      Adults

      100 mg PO once daily.[65465] [65744] [69584] [69587]

      Children and Adolescents

      2 to 5 mg/kg/dose (Max: 100 mg/dose) PO once daily.[65465] [65744] [69584] [69586] [69587]

      Therapeutic Drug Monitoring

      Maximum Dosage Limits

      • Adults

        200 mg/day PO; 300 mg PO once monthly plus daily dosing has also been used.

      • Geriatric

        200 mg/day PO; 300 mg PO once monthly plus daily dosing has also been used.

      • Adolescents

        15 to 17 years: 50 mg/day PO, with or without 300 mg PO once monthly, has been used.

        13 to 14 years weighing 40 kg or more: 50 mg/day PO, with or without 150 mg PO once monthly, has been used.

        13 to 14 years weighing less than 40 kg: 50 mg/day PO, with or without 100 mg PO once monthly, has been used.

      • Children

        10 to 12 years weighing 40 kg or more: 50 mg/day PO, with or without 150 mg PO once monthly, has been used.

        10 to 12 years weighing less than 40 kg: 50 mg/day PO, with or without 100 mg PO once monthly, has been used.

        1 to 9 years: 50 mg/day PO, with or without 100 mg PO once monthly, has been used.

      • Infants

        Safety and efficacy have not been established.

      • Neonates

        Safety and efficacy have not been established.

      Patients with Hepatic Impairment Dosing

      Avoid clofazimine in patients with hepatic impairment (Child-Pugh class A, B, or C) unless the benefit outweighs the risk.[63936]

      Patients with Renal Impairment Dosing

      No dosage adjustment needed. Use clofazimine with caution in patients with severe renal impairment.[32569][63936]

      † Off-label indication
      Revision Date: 05/29/2024, 02:48:00 AM

      References

      32569 - Aronoff GR, Bennett WM, Berns JS, et al. Drug prescribing in renal failure: dosing guidelines for adults and children, 5th ed. Philadelphia: American College of Physicians; 2007.53390 - U.S. Department of Health and Human Services. National Hansen's Disease Program Recommended Treatment Regimens. Accessed April 1, 2018. Available on the World Wide Web at http://www.hrsa.gov/hansensdisease/diagnosis/recommendedtreatment.html.63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.63942 - World Health Organization. Guidelines for the diagnosis, treatment and prevention of leprosy. WHO Library Cataloguing-in-Publication Data. 2018. 1-87.65465 - Nahid P, Mase SR, Battista G, et al. Treatment of drug-resistant tuberculosis: an official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med 2019;200:e93-142.65744 - Curry International Tuberculosis Center and California Department of Public Health. Drug-resistant tuberculosis: a survival guide for clinicians, third edition. 2016 (updated 2022). Accessed October 10, 2023. Available on the World Wide Web at: https://www.currytbcenter.ucsf.edu/products/cover-pages/drug-resistant-tuberculosis-survival-guide-clinicians-3rd-edition.69584 - Brode SK, Dwilow R, Kunimoto D, et al. Canadian tuberculosis standards 8th ed chapter 8: drug-resistant tuberculosis. Can J Respir Crit Care Sleep Med 2022;6:S1,109-28.69586 - World Health Organization. WHO operation handbook on tuberculosis: module 4: management of tuberculosis in children and adolescents. Geneva: World Health Organization; 2022. Retrieved Oct 10, 2023. Available on the World Wide Web at: https://www.who.int/publications-detail-redirect/9789240046832.69587 - World Health Organization. WHO operation handbook on tuberculosis: module 4:drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2022. Retrieved Oct 10, 2023. Available on the World Wide Web at: https://www.who.int/publications/i/item/9789240065116.

      How Supplied

      Clofazimine Oral capsule

      Lamprene 50mg Capsule (00028-0108) (Novartis Pharmaceuticals Corporation) (off market)

      Description/Classification

      Description

      Clofazimine is an oral antimycobacterial agent indicated for dapsone-sensitive or dapsone-resistant lepromatous leprosy as part of a combination regimen as well as lepromatous leprosy complicated by erythema nodosum leprosum. Because of resistance, clofazimine is not used alone for leprosy. Clofazimine exerts a slow bactericidal effect on Mycobacterium leprae and possesses anti-inflammatory properties in treating erythema nodosum leprosum reactions. Cases of QT prolongation with torsade de pointes have been reported with clofazimine; ECG monitoring is recommended. Other significant adverse reactions associated with clofazimine include skin discoloration that has been reported to result in depression and suicide and intestinal obstruction.[63936]

      Classifications

      • General Anti-infectives Systemic
        • Antimycobacterials
          • Agents for Leprosy
      Revision Date: 05/29/2024, 02:48:00 AM

      References

      63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

      Administration Information

      General Administration Information

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

       

      Tuberculosis patients

      • Directly observed therapy (DOT) is recommended for all children as well as adolescents and adults living with HIV.[34361] [34362] [61094]

      Route-Specific Administration

      Oral Administration

      • Administer orally with meals.[63936]
      • Pediatric patients must be able to swallow the capsule whole as the capsule should never be opened up.[53390]

      Clinical Pharmaceutics Information

      From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
        Revision Date: 05/29/2024, 02:48:00 AM

        References

        34361 - Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV: Department of Health and Human Services. Accessed Oct 10, 2023. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-oi/guidelines-pediatric-oi.pdf.34362 - Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the National Institutes of Health, the Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Accessed May 24, 2024. Available at https://clinicalinfo.hiv.gov/en/guidelines/53390 - U.S. Department of Health and Human Services. National Hansen's Disease Program Recommended Treatment Regimens. Accessed April 1, 2018. Available on the World Wide Web at http://www.hrsa.gov/hansensdisease/diagnosis/recommendedtreatment.html.61094 - Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: treatment of drug-susceptible tuberculosis. Clin Infect Dis 2016.63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

        Adverse Reactions

        Mild

        • acneiform rash
        • anorexia
        • dizziness
        • drowsiness
        • dysgeusia
        • fatigue
        • fever
        • headache
        • pruritus
        • skin discoloration
        • stool discoloration
        • urine discoloration
        • weight loss
        • xerosis

        Moderate

        • anemia
        • bone pain
        • constipation
        • cystitis
        • depression
        • edema
        • elevated hepatic enzymes
        • eosinophilia
        • hepatitis
        • hepatomegaly
        • hyperbilirubinemia
        • hypokalemia
        • jaundice
        • lymphadenopathy
        • QT prolongation

        Severe

        • GI bleeding
        • GI obstruction
        • retinopathy
        • suicidal ideation
        • thromboembolism
        • torsade de pointes

        0

        • abdominal pain
        • corneal deposits
        • diarrhea
        • hyperglycemia
        • ichthyosis
        • nausea
        • ocular irritation
        • ocular pruritus
        • photosensitivity
        • rash
        • visual impairment
        • vomiting

        Clofazimine may accumulate in various organs as crystals, including the mesenteric lymph nodes and histiocytes at the lamina propria of the intestinal mucosa, spleen, and liver. Deposition in the intestinal mucosa may lead to intestinal obstruction that may necessitate exploratory laparotomy. Splenic infarction, GI bleeding, and death have been reported. Gastrointestinal intolerance was reported in 40% to 50% of patients. Other GI adverse reactions reported in more than 1% of patients include epigastric and abdominal pain, diarrhea, nausea, and vomiting. GI adverse reactions reported in less than 1% of patients include splenic infarction, GI obstruction, GI bleeding, anorexia, constipation, weight loss, hepatitis, jaundice, eosinophilic enteritis, enlarged liver (hepatomegaly), elevated hepatic enzymes (i.e., AST), and elevated bilirubin (hyperbilirubinemia). If patients complain of pain in the abdomen, nausea, vomiting, or diarrhea, initiate appropriate medical investigations, and reduce the daily dose, increase the dosing interval, or discontinue clofazimine.[63936]

        Conjunctival and corneal deposits (crystal deposits) and pigmentation have been reported in more than 1% of patients. Other ophthalmic adverse effects reported in more than 1% of patients include visual impairment, ocular dryness, ocular burning, ocular pruritus, and ocular irritation. Maculopathy (bull's eye retinopathy) was reported in less than 1% of patients.[63936]

        Central nervous system adverse reactions reported in less than 1% of clofazimine-treated patients include dizziness, drowsiness, fatigue, giddiness, headache, dysgeusia (taste disorder), and neuralgia.[63936]

        Miscellaneous and laboratory adverse reported in more than 1% of clofazimine treated patients include elevated blood glucose (hyperglycemia) and elevated erythrocyte sedimentation rate (ESR). Anemia, bone pain, cystitis, edema, fever, lymphadenopathy, thromboembolism, and vascular pain were reported in less than 1% of patients. Other laboratory value alterations included eosinophilia, hypokalemia, and elevated albumin were reported in less than 1% of patients.[63936]

        Cases of torsade de pointes with QT prolongation have been reported in patients receiving more than clofazimine 100 mg/day or in combination with QT-prolonging medications. Monitor ECGs for QT prolongation and cardiac rhythm disturbances. For QT prolongation and torsade de pointes cases, patients must remain under medical surveillance.[63936]

        Depression and suicide secondary to skin discoloration were reported in less than 1% of clofazimine-treated patients. Advise patients about skin discoloration, and monitor patients for depression or suicidal ideation during clofazimine therapy.[63936]

        Revision Date: 05/29/2024, 02:48:00 AM

        References

        63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

        Contraindications/Precautions

        Absolute contraindications are italicized.

        • apheresis
        • AV block
        • bradycardia
        • breast-feeding
        • cardiomyopathy
        • celiac disease
        • contraception requirements
        • females
        • fever
        • geriatric
        • heart failure
        • hepatic disease
        • human immunodeficiency virus (HIV) infection
        • hyperparathyroidism
        • hypocalcemia
        • hypokalemia
        • hypomagnesemia
        • hypothermia
        • hypothyroidism
        • infertility
        • long QT syndrome
        • myocardial infarction
        • pheochromocytoma
        • pregnancy
        • pregnancy testing
        • QT prolongation
        • reproductive risk
        • rheumatoid arthritis
        • sickle cell disease
        • sleep deprivation
        • stroke
        • systemic lupus erythematosus (SLE)
        • torsade de pointes

        Clofazimine is contraindicated in any patient with known hypersensitivity to clofazimine or any of the excipients of clofazimine.[63936]

         

        Clofazimine causes orange-pink to brownish skin discoloration, as well as discoloration of the conjunctivae, tears, sweat, sputum, and feces. Advise patients that skin discoloration is likely to occur and that it may take several months or years to reverse after cessation of therapy.[63936]

        Avoid clofazimine in patients with hepatic disease or impairment (Child-Pugh Class A, B, or C) unless the benefit outweighs the risk.[63936]

        Carefully select dose, starting at the lower end of the dosage range, in geriatric patients, reflecting the greater frequency of decreased renal, hepatic, or cardiac function, and concomitant disease or drug therapy.[63936]

        Cases of torsade de pointes with QT prolongation have been reported in patients receiving clofazimine at doses more than 100 mg/day or in combination with medications that prolong the QT interval. Use clofazimine with caution in patients with conditions that may increase the risk of QT prolongation including congenital long QT syndrome, bradycardia, AV block, heart failure, stress-related cardiomyopathy, myocardial infarction, stroke, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances. Females, people 65 years and older, patients with sleep deprivation, pheochromocytoma, sickle cell disease, hypothyroidism, hyperparathyroidism, hypothermia, systemic inflammation (e.g., human immunodeficiency virus (HIV) infection, fever, and some autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus (SLE), and celiac disease) and patients undergoing apheresis procedures (e.g., plasmapheresis [plasma exchange], cytapheresis) may also be at increased risk for QT prolongation.[28432] [28457] [56592] [63936] [65180]

        Use clofazimine during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no studies of clofazimine use in pregnant women to inform drug-associated risk. A few cases reported in the literature describe the skin of infants born to pregnant mothers who received clofazimine during pregnancy as deeply pigmented at birth. Limited data are available regarding the reversibility of discoloration. Based on previous observations, discoloration gradually faded over the first year. Advise pregnant women of the potential risk to the fetus. In animal studies, embryotoxicity and fetotoxicity were evident. Retardation of fetal skull ossification, increased incidences of abortions and stillbirths, and impaired neonatal survival were observed with animal prenatal exposure of 25 mg/kg (equivalent to 0.6 times the maximum recommended human daily dose of 200 mg, based on body surface area comparisons).[63936]

        Clofazimine is excreted in human breast milk. Skin discoloration has been observed in breast-fed neonates of mothers receiving clofazimine. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for clofazimine and any potential adverse effects on the breast-fed infant from clofazimine or the underlying maternal condition.[63936]

        Clofazimine may be associated with reproductive risk. Conduct pregnancy testing for sexually-active females of reproductive potential before starting treatment with clofazimine. Discuss contraception requirements with the patient. Advise sexually-active females of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during clofazimine treatment and for at least 4 months after stopping clofazimine treatment. Advise males taking clofazimine to use a condom during intercourse while on clofazimine treatment and for at least 4 months after stopping clofazimine treatment. Female infertility or impaired fertility (i.e., reduced number of offspring and a lower proportion of implantation) was observed in an animal study. There are no non-clinical data on male fertility.[63936]

        Revision Date: 05/29/2024, 02:48:00 AM

        References

        28432 - Roden, DM. Drug-induced prolongation of the QT interval. New Engl J Med 2004;350:1013-22.28457 - Crouch MA, Limon L, Cassano AT. Clinical relevance and management of drug-related QT interval prolongation. Pharmacotherapy 2003;23:881-908.56592 - van Noord C, Eijgelsheim M, Stricker BH. Drug- and non-drug-associated QT interval prolongation. Br J Clin Pharmacol 2010;70(1):16-23.63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.65180 - Woosley RL, Heise CW, Gallo T, et al. QTFactors List. Oro Valley, AZ: AZCERT, Inc.; Accessed March 31, 2020. Available on the World Wide Web at: https://crediblemeds.org/ndfa-list/

        Mechanism of Action

        Clofazimine is an antimycobacterial agent that exerts a slow bactericidal effect on Mycobacterium leprae. Clofazimine binds preferentially to mycobacterial DNA and inhibits growth. The mechanism of action is postulated through its membrane-directed activity including the bacterial respiratory chain and ion transporters. Intracellular redox cycling, involving oxidation of reduced clofazimine, leads to the generation of antimicrobial reactive oxygen species (ROS), superoxide-hydrogen peroxide (H202). Interaction of clofazimine with membrane phospholipids results in the generation of antimicrobial lysophospholipids, which promote membrane dysfunction, resulting in interference with potassium uptake. Both mechanisms cause interference with cellular energy metabolism by disrupting ATP production. Clofazimine also exerts anti-inflammatory properties in treating erythema nodosum leprosum reactions. Anti-inflammatory activity is likely primarily through inhibition of T lymphocyte activation and proliferation. Clofazimine may indirectly interfere with the proliferation of T cells by promoting the release of ROS and E-series prostaglandins (PGs), especially PGE2 from neutrophils and monocytes.[63936]

        Revision Date: 05/29/2024, 02:48:00 AM

        References

        63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

        Pharmacokinetics

        Clofazimine is administered orally. The highly lipophilic drug is distributed mainly to fatty tissue and the reticuloendothelial system. It is taken up by macrophages throughout the body. Clofazimine is bound to alpha- and primarily beta-lipoproteins in serum, and the binding is saturable at plasma concentrations of approximately 10 mcg/mL. Binding to gamma-globulin and albumin is negligible. At autopsy, clofazimine crystals have been found in mesenteric lymph nodes, adrenals, subcutaneous fat, liver, bile, gallbladder, spleen, small intestine, muscles, bones, and skin.[63936]

         

        Information on the metabolism of clofazimine is limited; however, 3 metabolites were found in urine after repeated oral doses. After a single 300 mg dose, elimination of unchanged clofazimine and its metabolites was negligible in a 24-hour urine collection. Part of the ingested drug recovered from feces may represent excretion via the bile. A small amount is also eliminated in the sputum, sebum, and sweat. The mean elimination half-life of clofazimine is approximately 25 days (range 6.5 to 160 days) after repeated oral doses of 50 or 100 mg in leprosy patients.[63936]

         

        Affected cytochrome P450 isoenzymes and drug transporters: CYP2C8, CYP2D6, CYP3A4/5

        Clofazimine inhibits the metabolism of CYP2C8, CYP2D6, and CYP3A4/5 in vitro. It may increase the concentration of CYP3A4/5 substrates if used concomitantly.[63936]

        Route-Specific Pharmacokinetics

        Oral Route

        Clofazimine absorption ranges from 45% to 62% in leprosy patients. The average serum concentrations of clofazimine in leprosy patients treated with 100 and 300 mg daily were 0.7 mcg/mL and 1 mcg/mL, respectively. Time to reach peak plasma concentration (median Tmax) decreases from 12 hours to 8 hours under fed conditions relative to the fasted state.[63936]

        Revision Date: 05/29/2024, 02:48:00 AM

        References

        63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

        Pregnancy/Breast-feeding

        pregnancy

        Use clofazimine during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no studies of clofazimine use in pregnant women to inform drug-associated risk. A few cases reported in the literature describe the skin of infants born to pregnant mothers who received clofazimine during pregnancy as deeply pigmented at birth. Limited data are available regarding the reversibility of discoloration. Based on previous observations, discoloration gradually faded over the first year. Advise pregnant women of the potential risk to the fetus. In animal studies, embryotoxicity and fetotoxicity were evident. Retardation of fetal skull ossification, increased incidences of abortions and stillbirths, and impaired neonatal survival were observed with animal prenatal exposure of 25 mg/kg (equivalent to 0.6 times the maximum recommended human daily dose of 200 mg, based on body surface area comparisons).[63936]

        breast-feeding

        Clofazimine is excreted in human breast milk. Skin discoloration has been observed in breast-fed neonates of mothers receiving clofazimine. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for clofazimine and any potential adverse effects on the breast-fed infant from clofazimine or the underlying maternal condition.[63936]

        Revision Date: 05/29/2024, 02:48:00 AM

        References

        63936 - Lamprene (clofazimine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019 Jan.

        Interactions

        Level 1 (Severe)

        • Cisapride
        • Dronedarone
        • Ketoconazole
        • Levoketoconazole
        • Pimozide
        • Thioridazine

        Level 2 (Major)

        • Adagrasib
        • Amiodarone
        • Amisulpride
        • Amoxicillin; Clarithromycin; Omeprazole
        • Anagrelide
        • Arsenic Trioxide
        • Artemether; Lumefantrine
        • Asenapine
        • Azithromycin
        • Bedaquiline
        • Buprenorphine
        • Buprenorphine; Naloxone
        • Ceritinib
        • Chloroquine
        • Chlorpromazine
        • Citalopram
        • Clarithromycin
        • Crizotinib
        • Desflurane
        • Deutetrabenazine
        • Dextromethorphan; Quinidine
        • Disopyramide
        • Dofetilide
        • Droperidol
        • Encorafenib
        • Entrectinib
        • Eribulin
        • Erythromycin
        • Fexinidazole
        • Flecainide
        • Foscarnet
        • Glasdegib
        • Halogenated Anesthetics
        • Hydroxychloroquine
        • Ibutilide
        • Iloperidone
        • Inotuzumab Ozogamicin
        • Isoflurane
        • Ivosidenib
        • Lansoprazole; Amoxicillin; Clarithromycin
        • Lefamulin
        • Lemborexant
        • Lenvatinib
        • Lofexidine
        • Lopinavir; Ritonavir
        • Macimorelin
        • Methadone
        • Midostaurin
        • Mifepristone
        • Mobocertinib
        • Moxifloxacin
        • Nanoparticle Albumin-Bound Sirolimus
        • Nilotinib
        • Ondansetron
        • Osimertinib
        • Oxaliplatin
        • Ozanimod
        • Pacritinib
        • Paliperidone
        • Panobinostat
        • Pazopanib
        • Pentamidine
        • Pimavanserin
        • Pitolisant
        • Ponesimod
        • Procainamide
        • Propafenone
        • Quetiapine
        • Quinidine
        • Quinine
        • Quizartinib
        • Ranolazine
        • Ribociclib
        • Ribociclib; Letrozole
        • Saquinavir
        • Selpercatinib
        • Sevoflurane
        • Siponimod
        • Sorafenib
        • Sotalol
        • Tetrabenazine
        • Toremifene
        • Trazodone
        • Vandetanib
        • Vemurafenib
        • Vonoprazan; Amoxicillin; Clarithromycin
        • Ziprasidone

        Level 3 (Moderate)

        • Alfentanil
        • Alfuzosin
        • Apomorphine
        • Aripiprazole
        • Atomoxetine
        • Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
        • Bismuth Subsalicylate; Metronidazole; Tetracycline
        • Cabotegravir; Rilpivirine
        • Carbamazepine
        • Celecoxib; Tramadol
        • Ciprofloxacin
        • Clozapine
        • Codeine; Phenylephrine; Promethazine
        • Codeine; Promethazine
        • Cyclosporine
        • Dasatinib
        • Degarelix
        • Dexmedetomidine
        • Dolasetron
        • Dolutegravir; Rilpivirine
        • Donepezil
        • Donepezil; Memantine
        • Efavirenz
        • Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate
        • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
        • Eliglustat
        • Emtricitabine; Rilpivirine; Tenofovir alafenamide
        • Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate
        • Escitalopram
        • Ethosuximide
        • Etrasimod
        • Fentanyl
        • Finerenone
        • Fingolimod
        • Fluconazole
        • Fluoxetine
        • Fluvoxamine
        • Fostemsavir
        • Gemifloxacin
        • Gemtuzumab Ozogamicin
        • Gilteritinib
        • Goserelin
        • Granisetron
        • Haloperidol
        • Histrelin
        • Hydroxyzine
        • Itraconazole
        • Lapatinib
        • Leuprolide
        • Leuprolide; Norethindrone
        • Levofloxacin
        • Lithium
        • Loperamide
        • Loperamide; Simethicone
        • Maprotiline
        • Mavorixafor
        • Mefloquine
        • Metronidazole
        • Mirtazapine
        • Ofloxacin
        • Olanzapine
        • Olanzapine; Fluoxetine
        • Olanzapine; Samidorphan
        • Osilodrostat
        • Pasireotide
        • Posaconazole
        • Primaquine
        • Promethazine
        • Promethazine; Dextromethorphan
        • Promethazine; Phenylephrine
        • Relugolix
        • Relugolix; Estradiol; Norethindrone acetate
        • Rilpivirine
        • Risperidone
        • Romidepsin
        • Sertraline
        • Sirolimus
        • Sodium Stibogluconate
        • Solifenacin
        • Sunitinib
        • Tacrolimus
        • Tamoxifen
        • Telavancin
        • Tolterodine
        • Tramadol
        • Tramadol; Acetaminophen
        • Triazolam
        • Triclabendazole
        • Triptorelin
        • Vardenafil
        • Venlafaxine
        • Voclosporin
        • Voriconazole
        • Vorinostat
        • Warfarin

        Level 4 (Minor)

        • Fluphenazine
        • Perphenazine
        • Perphenazine; Amitriptyline
        • Prochlorperazine
        • Trifluoperazine
        Adagrasib: (Major) Concomitant use of adagrasib and clofazimine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [68325] ALFentanil: (Moderate) Monitor for increased toxicity of alfentanil if used concomitantly with clofazimine. Concomitant use may increase the concentration of alfentanil, increasing the risk of adverse effects. Alfentanil is a CYP3A4 substrate that has a narrow therapeutic range; in vitro data suggest clofazimine inhibits CYP3A4. [30072] [63936] Alfuzosin: (Moderate) Concomitant use of clofazimine and alfuzosin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28261] [63936] Amiodarone: (Major) Concomitant use of amiodarone and clofazimine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after drug discontinuation. [28224] [28432] [28457] [63936] Amisulpride: (Major) Concomitant use of clofazimine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [65068] Amoxicillin; Clarithromycin; Omeprazole: (Major) Concomitant use of clofazimine and clarithromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28238] [63936] Anagrelide: (Major) Concomitant use of clofazimine and anagrelide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [30163] [63936] Apomorphine: (Moderate) Concomitant use of clofazimine and apomorphine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28661] [63936] ARIPiprazole: (Moderate) Monitor for aripiprazole-related adverse reactions during concomitant use of clofazimine. Patients receiving both a CYP2D6 inhibitor plus clofazimine may require an aripiprazole dosage adjustment. Dosing recommendations vary based on aripiprazole dosage form, CYP2D6 inhibitor strength, and CYP2D6 metabolizer status. See prescribing information for details. Concomitant use may increase aripiprazole exposure and risk for side effects. Additionally, concomitant use may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. Aripiprazole is a CYP3A and CYP2D6 substrate; clofazimine is a weak CYP3A inhibitor. Both medications have been associated with QT prolongation. [42845] [53394] [60196] [63328] [63936] [68911] Arsenic Trioxide: (Major) Concomitant use of clofazimine and arsenic trioxide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [59438] [63936] Artemether; Lumefantrine: (Major) Concomitant use of clofazimine and artemether increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [35401] [63936] (Major) Concomitant use of clofazimine and artemether; lumefantrine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [35401] [63936] Asenapine: (Major) Concomitant use of clofazimine and asenapine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [36343] [63936] Atomoxetine: (Moderate) Concomitant use of clofazimine and atomoxetine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28405] [63936] Azithromycin: (Major) Concomitant use of clofazimine and azithromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28855] [63936] [65170] Bedaquiline: (Major) Concomitant use of clofazimine and bedaquiline increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [52746] [63936] Bismuth Subcitrate Potassium; metroNIDAZOLE; Tetracycline: (Moderate) Concomitant use of clofazimine and metronidazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [36894] [63936] Bismuth Subsalicylate; metroNIDAZOLE; Tetracycline: (Moderate) Concomitant use of clofazimine and metronidazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [36894] [63936] Buprenorphine: (Major) Concomitant use of clofazimine and buprenorphine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [41235] [60270] [63936] Buprenorphine; Naloxone: (Major) Concomitant use of clofazimine and buprenorphine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [41235] [60270] [63936] Cabotegravir; Rilpivirine: (Moderate) Concomitant use of clofazimine and rilpivirine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with rilpivirine is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [44376] [63936] carBAMazepine: (Moderate) Monitor for increased toxicity of carbamazepine if used concomitantly with clofazimine. Concomitant use may increase the concentration of carbamazepine, increasing the risk of adverse effects. Carbamazepine is a CYP3A4 substrate that has a narrow therapeutic index; in vitro data suggest clofazimine inhibits CYP3A4. [41237] [63936] Celecoxib; Tramadol: (Moderate) Consider a tramadol dosage reduction until stable drug effects are achieved if coadministration with clofazimine is necessary. Closely monitor for seizures, serotonin syndrome, and signs of sedation and respiratory depression. Respiratory depression from increased tramadol exposure may be fatal. Concurrent use of clofazimine, a weak CYP3A inhibitor, may increase tramadol exposure and result in greater CYP2D6 metabolism thereby increasing exposure to the active metabolite M1, which is a more potent mu-opioid agonist. [32475] [40255] [51440] [63936] Ceritinib: (Major) Concomitant use of clofazimine and ceritinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [57094] [63936] Chloroquine: (Major) Concomitant use of clofazimine and chloroquine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28229] [29758] [63936] [65170] chlorproMAZINE: (Major) Concomitant use of clofazimine and chlorpromazine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28415] [43065] [63936] Ciprofloxacin: (Moderate) Concomitant use of clofazimine and ciprofloxacin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [43411] [63936] Cisapride: (Contraindicated) Avoid concomitant use of clofazimine and cisapride due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [28978] [47221] [63936] Citalopram: (Major) Concomitant use of clofazimine and citalopram increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28269] [63936] Clarithromycin: (Major) Concomitant use of clofazimine and clarithromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28238] [63936] cloZAPine: (Moderate) Concomitant use of clofazimine and clozapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28262] [63936] Codeine; Phenylephrine; Promethazine: (Moderate) Concomitant use of clofazimine and promethazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [55578] [63936] Codeine; Promethazine: (Moderate) Concomitant use of clofazimine and promethazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [55578] [63936] Crizotinib: (Major) Concomitant use of clofazimine and crizotinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [45458] [63936] cycloSPORINE: (Moderate) Monitor for increased toxicity of cyclosporine if used concomitantly with clofazimine. Concomitant use may increase the concentration of cyclosporine, increasing the risk of adverse effects. Cyclosporine is a CYP3A4 substrate that has a narrow therapeutic range; in vitro data suggest clofazimine inhibits CYP3A4. [28404] [63936] Dasatinib: (Moderate) Concomitant use of clofazimine and dasatinib may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [32387] [63936] Degarelix: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., degarelix) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [46869] [63936] Desflurane: (Major) Concomitant use of clofazimine and halogenated anesthetics increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28457] [28458] [28754] [28755] [28756] [63936] Deutetrabenazine: (Major) Monitor ECGs for QT prolongation when clofazimine is administered with deutetrabenazine. QT prolongation and torsade de pointes (TdP) have been reported in patients receiving clofazimine in combination with QT prolonging medications. Deutetrabenazine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when deutetrabenazine is administered within the recommended dosage range. [61845] [63936] dexmedeTOMIDine: (Moderate) Concomitant use of dexmedetomidine and clofazimine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [67509] Dextromethorphan; quiNIDine: (Major) Concomitant use of clofazimine and quinidine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [42280] [47357] [63936] Disopyramide: (Major) Concomitant use of clofazimine and disopyramide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28228] [63936] Dofetilide: (Major) Concomitant use of clofazimine and dofetilide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28221] [28432] [28457] [63936] Dolasetron: (Moderate) Concomitant use of clofazimine and dolasetron may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28308] [50275] [63936] Dolutegravir; Rilpivirine: (Moderate) Concomitant use of clofazimine and rilpivirine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with rilpivirine is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [44376] [63936] Donepezil: (Moderate) Concomitant use of clofazimine and donepezil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [59322] [63936] Donepezil; Memantine: (Moderate) Concomitant use of clofazimine and donepezil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [59322] [63936] Dronedarone: (Contraindicated) Avoid concomitant use of clofazimine and dronedarone due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [36101] [63936] droPERidol: (Major) Concomitant use of clofazimine and droperidol increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [57224] [63936] Efavirenz: (Moderate) Concomitant use of clofazimine and efavirenz may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28442] [63936] Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Concomitant use of clofazimine and efavirenz may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28442] [63936] Efavirenz; lamiVUDine; Tenofovir Disoproxil Fumarate: (Moderate) Concomitant use of clofazimine and efavirenz may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28442] [63936] Eliglustat: (Moderate) Concomitant use of clofazimine and eliglustat may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [57803] [63936] Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Moderate) Concomitant use of clofazimine and rilpivirine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with rilpivirine is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [44376] [63936] Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Moderate) Concomitant use of clofazimine and rilpivirine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with rilpivirine is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [44376] [63936] Encorafenib: (Major) Concomitant use of clofazimine and encorafenib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63317] [63936] Entrectinib: (Major) Concomitant use of clofazimine and entrectinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [64567] eriBULin: (Major) Concomitant use of clofazimine and eribulin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [42449] [63936] Erythromycin: (Major) Concomitant use of clofazimine and erythromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28251] [43258] [63936] Escitalopram: (Moderate) Concomitant use of clofazimine and escitalopram may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28270] [63936] Ethosuximide: (Moderate) Monitor for increased toxicity of ethosuximide if used concomitantly with clofazimine. Concomitant use may increase the concentration of ethosuximide, increasing the risk of adverse effects. Ethosuximide is a CYP3A4 substrate that has a narrow therapeutic index; in vitro data suggest clofazimine inhibits CYP3A4. [28001] [63936] Etrasimod: (Moderate) Concomitant use of etrasimod and clofazimine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. Etrasimod has a limited effect on the QT/QTc interval at therapeutic doses but may cause bradycardia and atrioventricular conduction delays which may increase the risk for TdP in patients with a prolonged QT/QTc interval. [63936] [69114] fentaNYL: (Moderate) Monitor for increased toxicity of fentanyl if used concomitantly with clofazimine. Concomitant use may increase the concentration of fentanyl, increasing the risk of adverse effects. Fentanyl is a CYP3A4 substrate that has a narrow therapeutic range; in vitro data suggest clofazimine inhibits CYP3A4. [29623] [63936] Fexinidazole: (Major) Concomitant use of clofazimine and fexinidazole increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [66812] Finerenone: (Moderate) Monitor serum potassium during initiation or dose adjustment of either finerenone or clofazimine; a finerenone dosage reduction may be necessary. Concomitant use may increase finerenone exposure and the risk of hyperkalemia. Finerenone is a CYP3A substrate and clofazimine is a weak CYP3A inhibitor. Coadministration with another weak CYP3A inhibitor increased overall exposure to finerenone by 21%. [63936] [66793] Fingolimod: (Moderate) Concomitant use of clofazimine and fingolimod may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [41823] [63936] Flecainide: (Major) Concomitant use of clofazimine and flecainide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [23774] [28752] [63936] Fluconazole: (Moderate) Concomitant use of clofazimine and fluconazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28674] [63936] FLUoxetine: (Moderate) Concomitant use of clofazimine and fluoxetine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [32127] [44058] [63936] fluPHENAZine: (Minor) QT/QTc prolongation can occur with concomitant use of clofazimine and fluphenazine although the risk of developing torsade de pointes (TdP) is low. Additional steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, may be considered in patients with additional risk factors for TdP. [28415] [63936] fluvoxaMINE: (Moderate) Concomitant use of clofazimine and fluvoxamine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [50507] [63936] Foscarnet: (Major) Concomitant use of clofazimine and foscarnet increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28377] [63936] Fostemsavir: (Moderate) Concomitant use of clofazimine and fostemsavir may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with fostemsavir is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 4 times the recommended daily dose. [63936] [65666] Gemifloxacin: (Moderate) Concomitant use of clofazimine and gemifloxacin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28424] [63936] Gemtuzumab Ozogamicin: (Moderate) Concomitant use of clofazimine and gemtuzumab may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [62292] [63936] Gilteritinib: (Moderate) Concomitant use of clofazimine and gilteritinib may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63787] [63936] Glasdegib: (Major) Concomitant use of clofazimine and glasdegib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63777] [63936] Goserelin: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28592] [63936] Granisetron: (Moderate) Concomitant use of clofazimine and granisetron may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [31723] [63936] Halogenated Anesthetics: (Major) Concomitant use of clofazimine and halogenated anesthetics increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28457] [28458] [28754] [28755] [28756] [63936] Haloperidol: (Moderate) Concomitant use of clofazimine and haloperidol may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The intravenous route may carry a higher risk for haloperidol-induced QT/QTc prolongation than other routes of administration. [28307] [63936] Histrelin: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., histrelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [30369] [63936] Hydroxychloroquine: (Major) Concomitant use of clofazimine and hydroxychloroquine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [41806] [63936] [65170] hydrOXYzine: (Moderate) Concomitant use of clofazimine and hydroxyzine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [47129] [63936] Ibutilide: (Major) Concomitant use of clofazimine and ibutilide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [41830] [63936] Iloperidone: (Major) Concomitant use of clofazimine and iloperidone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [36146] [63936] Inotuzumab Ozogamicin: (Major) Concomitant use of clofazimine and inotuzumab increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [62245] [63936] Isoflurane: (Major) Concomitant use of clofazimine and halogenated anesthetics increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28457] [28458] [28754] [28755] [28756] [63936] Itraconazole: (Moderate) Concomitant use of clofazimine and itraconazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [40233] [57441] [63936] Ivosidenib: (Major) Concomitant use of clofazimine and ivosidenib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63368] [63936] Ketoconazole: (Contraindicated) Avoid concomitant use of clofazimine and ketoconazole due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [27982] [63936] [67231] Lansoprazole; Amoxicillin; Clarithromycin: (Major) Concomitant use of clofazimine and clarithromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28238] [63936] Lapatinib: (Moderate) Concomitant use of clofazimine and lapatinib may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [33192] [63936] Lefamulin: (Major) Concomitant use of clofazimine and lefamulin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [64576] Lemborexant: (Major) Limit the dose of lemborexant to a maximum of 5 mg PO once daily if coadministered with clofazimine as concurrent use may increase lemborexant exposure and the risk of adverse effects. Lemborexant is a CYP3A4 substrate; clofazimine is a weak CYP3A4 inhibitor. Coadministration of lemborexant with a weak CYP3A4 inhibitor is predicted to increase lemborexant exposure by less than 2-fold. [63936] [64870] Lenvatinib: (Major) Concomitant use of clofazimine and lenvatinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [58782] [63936] Leuprolide: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., leuprolide) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [43800] [63936] Leuprolide; Norethindrone: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., leuprolide) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [43800] [63936] levoFLOXacin: (Moderate) Concomitant use of clofazimine and levofloxacin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28421] [63936] Levoketoconazole: (Contraindicated) Avoid concomitant use of clofazimine and ketoconazole due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [27982] [63936] [67231] Lithium: (Moderate) Concomitant use of clofazimine and lithium may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [59809] [59810] [59811] [63936] Lofexidine: (Major) Concomitant use of clofazimine and lofexidine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63161] [63936] Loperamide: (Moderate) Concomitant use of clofazimine and loperamide may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [33607] [63936] Loperamide; Simethicone: (Moderate) Concomitant use of clofazimine and loperamide may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [33607] [63936] Lopinavir; Ritonavir: (Major) Concomitant use of clofazimine and lopinavir; ritonavir increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28341] [63936] [65170] Macimorelin: (Major) Concomitant use of clofazimine and macimorelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [62723] [63936] Maprotiline: (Moderate) Concomitant use of clofazimine and maprotiline may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28759] [63936] Mavorixafor: (Moderate) Concomitant use of mavorixafor and clofazimine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with mavorixafor is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 2 times the maximum recommended dose. [63936] [70577] Mefloquine: (Moderate) Concomitant use of clofazimine and mefloquine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28301] [63936] Methadone: (Major) Concomitant use of clofazimine and methadone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [33136] [63936] metroNIDAZOLE: (Moderate) Concomitant use of clofazimine and metronidazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [36894] [63936] Midostaurin: (Major) Concomitant use of clofazimine and midostaurin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [61906] [63936] miFEPRIStone: (Major) Concomitant use of clofazimine and mifepristone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [48697] [63936] Mirtazapine: (Moderate) Concomitant use of clofazimine and mirtazapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [40942] [63936] Mobocertinib: (Major) Concomitant use of clofazimine and mobocertinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [66990] Moxifloxacin: (Major) Concomitant use of clofazimine and moxifloxacin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28423] [63936] Nanoparticle Albumin-Bound Sirolimus: (Major) Reduce the nab-sirolimus dose to 56 mg/m2 during concomitant use of clofazimine. Coadministration may increase sirolimus concentrations and increase the risk for sirolimus-related adverse effects. Sirolimus is a CYP3A substrate and clofazimine is a weak CYP3A inhibitor. [63936] [67136] Nilotinib: (Major) Concomitant use of clofazimine and nilotinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [58766] [63936] Ofloxacin: (Moderate) Concomitant use of clofazimine and ofloxacin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [29833] [30738] [48869] [63936] OLANZapine: (Moderate) Concomitant use of clofazimine and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28785] [32732] [32734] [32745] [32746] [63936] OLANZapine; FLUoxetine: (Moderate) Concomitant use of clofazimine and fluoxetine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [32127] [44058] [63936] (Moderate) Concomitant use of clofazimine and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28785] [32732] [32734] [32745] [32746] [63936] OLANZapine; Samidorphan: (Moderate) Concomitant use of clofazimine and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28785] [32732] [32734] [32745] [32746] [63936] Ondansetron: (Major) Concomitant use of clofazimine and ondansetron increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Do not exceed 16 mg of IV ondansetron in a single dose; the degree of QT prolongation associated with ondansetron significantly increases above this dose. [31266] [63936] Osilodrostat: (Moderate) Concomitant use of clofazimine and osilodrostat may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [65098] Osimertinib: (Major) Concomitant use of clofazimine and osimertinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [60297] [63936] Oxaliplatin: (Major) Concomitant use of clofazimine and oxaliplatin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [41958] [63936] Ozanimod: (Major) Concomitant use of clofazimine and ozanimod increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Ozanimod has a limited effect on the QT/QTc interval at therapeutic doses but may cause bradycardia and atrioventricular conduction delays which may increase the risk for TdP in patients with a prolonged QT/QTc interval. [63936] [65169] Pacritinib: (Major) Concomitant use of pacritinib and clofazimine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [67427] Paliperidone: (Major) Concomitant use of clofazimine and paliperidone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [40936] [63936] Panobinostat: (Major) Concomitant use of clofazimine and panobinostat increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [58821] [63936] Pasireotide: (Moderate) Concomitant use of clofazimine and pasireotide may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [52611] [63936] PAZOPanib: (Major) Concomitant use of clofazimine and pazopanib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [37098] [63936] Pentamidine: (Major) Concomitant use of clofazimine and systemic pentamidine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [23620] [23778] [28419] [28879] [63936] Perphenazine: (Minor) QT/QTc prolongation can occur with concomitant use of clofazimine and perphenazine although the risk of developing torsade de pointes (TdP) is low. Additional steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, may be considered in patients with additional risk factors for TdP. [28415] [63936] Perphenazine; Amitriptyline: (Minor) QT/QTc prolongation can occur with concomitant use of clofazimine and perphenazine although the risk of developing torsade de pointes (TdP) is low. Additional steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, may be considered in patients with additional risk factors for TdP. [28415] [63936] Pimavanserin: (Major) Concomitant use of clofazimine and pimavanserin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [60748] [63936] Pimozide: (Contraindicated) Avoid concomitant use of clofazimine and pimozide due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [43463] [63936] Pitolisant: (Major) Concomitant use of clofazimine and pitolisant increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [64562] Ponesimod: (Major) Concomitant use of clofazimine and ponesimod increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Ponesimod has a limited effect on the QT/QTc interval at therapeutic doses but may cause bradycardia and atrioventricular conduction delays which may increase the risk for TdP in patients with a prolonged QT/QTc interval. [63936] [66527] Posaconazole: (Moderate) Concomitant use of clofazimine and posaconazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [32723] [63936] Primaquine: (Moderate) Concomitant use of clofazimine and primaquine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [41984] [63936] Procainamide: (Major) Concomitant use of clofazimine and procainamide increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28250] [63936] Prochlorperazine: (Minor) QT/QTc prolongation can occur with concomitant use of clofazimine and prochlorperazine although the risk of developing torsade de pointes (TdP) is low. Additional steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, may be considered in patients with additional risk factors for TdP. [28415] [63936] Promethazine: (Moderate) Concomitant use of clofazimine and promethazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [55578] [63936] Promethazine; Dextromethorphan: (Moderate) Concomitant use of clofazimine and promethazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [55578] [63936] Promethazine; Phenylephrine: (Moderate) Concomitant use of clofazimine and promethazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [55578] [63936] Propafenone: (Major) Concomitant use of clofazimine and propafenone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28287] [63936] QUEtiapine: (Major) Concomitant use of clofazimine and quetiapine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [29118] [63936] quiNIDine: (Major) Concomitant use of clofazimine and quinidine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [42280] [47357] [63936] quiNINE: (Major) Concomitant use of clofazimine and quinine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [31403] [63936] Quizartinib: (Major) Concomitant use of quizartinib and clofazimine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [69220] Ranolazine: (Major) Concomitant use of clofazimine and ranolazine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [31938] [63936] Relugolix: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., relugolix) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [66183] Relugolix; Estradiol; Norethindrone acetate: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., relugolix) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [66183] Ribociclib: (Major) Concomitant use of clofazimine and ribociclib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [61816] [63936] Ribociclib; Letrozole: (Major) Concomitant use of clofazimine and ribociclib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [61816] [63936] Rilpivirine: (Moderate) Concomitant use of clofazimine and rilpivirine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with rilpivirine is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [44376] [63936] risperiDONE: (Moderate) Concomitant use of clofazimine and risperidone may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28225] [28414] [28416] [63936] romiDEPsin: (Moderate) Concomitant use of clofazimine and romidepsin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [37292] [63936] Saquinavir: (Major) Concomitant use of clofazimine and saquinavir increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28995] [63936] Selpercatinib: (Major) Concomitant use of clofazimine and selpercatinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [65387] Sertraline: (Moderate) Concomitant use of clofazimine and sertraline may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with sertraline is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 2 times the maximum recommended dose. [28343] [63936] Sevoflurane: (Major) Concomitant use of clofazimine and halogenated anesthetics increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28457] [28458] [28754] [28755] [28756] [63936] Siponimod: (Major) Concomitant use of clofazimine and siponimod increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [63936] [64031] Sirolimus: (Moderate) Monitor sirolimus concentrations and adjust sirolimus dosage as appropriate during concomitant use of clofazimine. Coadministration may increase sirolimus concentrations and increase the risk for sirolimus-related adverse effects. Sirolimus is a CYP3A substrate and clofazimine is a weak CYP3A inhibitor. [28610] [63936] Sodium Stibogluconate: (Moderate) Concomitant use of sodium stibogluconate and clofazimine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [64608] Solifenacin: (Moderate) Concomitant use of clofazimine and solifenacin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [30515] [63936] SORAfenib: (Major) Concomitant use of clofazimine and sorafenib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [31832] [63936] Sotalol: (Major) Concomitant use of clofazimine and sotalol increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28234] [63936] SUNItinib: (Moderate) Concomitant use of clofazimine and sunitinib may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [31970] [63936] Tacrolimus: (Moderate) Concomitant use of clofazimine and tacrolimus may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28611] [63936] Tamoxifen: (Moderate) Concomitant use of clofazimine and tamoxifen may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [61870] [61871] [61872] [63589] [63936] Telavancin: (Moderate) Concomitant use of clofazimine and telavancin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [36615] [63936] Tetrabenazine: (Major) Concomitant use of clofazimine and tetrabenazine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [34389] [63936] Thioridazine: (Contraindicated) Avoid concomitant use of clofazimine and thioridazine due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. [28225] [28293] [63936] Tolterodine: (Moderate) Concomitant use of clofazimine and tolterodine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The risk for tolterodine-associated QT/QTc prolongation may be increased in poor CYP2D6 metabolizers. [31112] [63936] Toremifene: (Major) Concomitant use of clofazimine and toremifene increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28822] [63936] traMADol: (Moderate) Consider a tramadol dosage reduction until stable drug effects are achieved if coadministration with clofazimine is necessary. Closely monitor for seizures, serotonin syndrome, and signs of sedation and respiratory depression. Respiratory depression from increased tramadol exposure may be fatal. Concurrent use of clofazimine, a weak CYP3A inhibitor, may increase tramadol exposure and result in greater CYP2D6 metabolism thereby increasing exposure to the active metabolite M1, which is a more potent mu-opioid agonist. [32475] [40255] [51440] [63936] Tramadol; Acetaminophen: (Moderate) Consider a tramadol dosage reduction until stable drug effects are achieved if coadministration with clofazimine is necessary. Closely monitor for seizures, serotonin syndrome, and signs of sedation and respiratory depression. Respiratory depression from increased tramadol exposure may be fatal. Concurrent use of clofazimine, a weak CYP3A inhibitor, may increase tramadol exposure and result in greater CYP2D6 metabolism thereby increasing exposure to the active metabolite M1, which is a more potent mu-opioid agonist. [32475] [40255] [51440] [63936] traZODone: (Major) Concomitant use of clofazimine and trazodone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [38831] [63936] Triazolam: (Moderate) Monitor for signs of triazolam toxicity during coadministration with clofazimine and consider appropriate dose reduction of triazolam if clinically indicated. Coadministration may increase triazolam exposure. Triazolam is a sensitive CYP3A substrate and clofazimine is a weak CYP3A inhibitor. [41543] [63936] Triclabendazole: (Moderate) Concomitant use of clofazimine and triclabendazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [63936] [63962] Trifluoperazine: (Minor) QT/QTc prolongation can occur with concomitant use of clofazimine and trifluoperazine although the risk of developing torsade de pointes (TdP) is low. Additional steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, may be considered in patients with additional risk factors for TdP. [28415] [63936] Triptorelin: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., triptorelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [45411] [63936] Vandetanib: (Major) Concomitant use of clofazimine and vandetanib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [43901] [63936] Vardenafil: (Moderate) Concomitant use of clofazimine and vardenafil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28216] [63936] Vemurafenib: (Major) Concomitant use of clofazimine and vemurafenib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [45335] [63936] Venlafaxine: (Moderate) Concomitant use of clofazimine and venlafaxine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [33715] [63936] Voclosporin: (Moderate) Concomitant use of clofazimine and voclosporin may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with voclosporin is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 3 times the maximum recommended dose. [63936] [66336] Vonoprazan; Amoxicillin; Clarithromycin: (Major) Concomitant use of clofazimine and clarithromycin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28238] [63936] Voriconazole: (Moderate) Concomitant use of clofazimine and voriconazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [28158] [63936] Vorinostat: (Moderate) Concomitant use of clofazimine and vorinostat may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. [32789] [63936] Warfarin: (Moderate) Closely monitor the INR if coadministration of warfarin with clofazimine is necessary as concurrent use may increase the exposure of warfarin leading to increased bleeding risk. Clofazimine is a weak CYP3A4 inhibitor and the R-enantiomer of warfarin is a CYP3A4 substrate. The S-enantiomer of warfarin exhibits 2 to 5 times more anticoagulant activity than the R-enantiomer, but the R-enantiomer generally has a slower clearance. [28549] [63936] Ziprasidone: (Major) Concomitant use of clofazimine and ziprasidone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. [28233] [63936]
        Revision Date: 05/29/2024, 02:48:00 AM

        References

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