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Mar.18.2021

Intranasal Influenza Vaccine

Indications/Dosage

Labeled

  • seasonal influenza prophylaxis

Off-Label

    † Off-label indication

    For annual seasonal influenza prophylaxis in healthy persons aged 2 to 49 years

    Intranasal dosage (FluMist Trivalent and Quadrivalent)

    Adults 50 years and older

    Not recommended at this time; further safety and efficacy data are needed. The effectiveness of the vaccine was not demonstrated in a trial of 641 patients 50 to 64 years of age. NOTE: If indicated, these patients should receive the annual injectable flu vaccine. Since elderly patients are considered a 'high-risk' group for influenza, vaccination with the injectable form is important for this age group.[28647]

    Adults 18 to 49 years old

    0.2 mL/dose intranasally (0.1 mL into each nostril, for a total of 0.2 mL).[52656]

    Children and Adolescents 9 to 17 years old

    0.2 mL/dose intranasally (0.1 mL into each nostril, for a total of 0.2 mL).[52656]

    Children 2 to 8 years

    0.2 mL/dose intranasally (0.1 mL into each nostril, for a total of 0.2 mL).[52656] Repeat the dose at least 4 weeks later for those who are receiving the flu vaccine for the first time. The Advisory Committee on Immunization Practices (ACIP) recommends that infants and children aged 6 months through 8 years who have previously received at least 2 doses of trivalent or quadrivalent influenza vaccine before the beginning of the influenza season, receive only 1 dose for the current season. The 2 previous doses need not have been given during the same season or consecutive seasons.[63436]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      < 50 years: 0.2 mL/dose intranasally.

      >= 50 years: Safety and efficacy have not been established.

    • Geriatric

      Safety and efficacy have not been established.

    • Adolescents

      0.2 ml/dose intranasally.

    • Children

      >= 2 years: 0.2 mL/dose intranasally.

      < 2 years: Safety and efficacy have not been established.

    • Infants

      Safety and efficacy have not been established.

    Patients with Hepatic Impairment Dosing

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    † Off-label indication
    Revision Date: 03/18/2021, 04:57:57 PM

    References

    28647 - Centers for Disease Control and Prevention (CDC). Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60:1-26.52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.53026 - Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older-United States, 2021. MMWR 2021;70(6):189-196.63327 - Centers for Disease Control and Prevention (CDC). Update: ACIP recommedations for the use of quadrivalent live attenuated influenza vaccine (LAIV4) - United States, 2018-19 influenza season. MMWR 2018; 67; 643-645.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458865686 - U.S. Food & Drug Administration. Influenza vaccine for the 2021-2022 season. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2020-2021-season?utm_campaign=What%27sNew2020-07-02&utm_medium=email&utm_source=Eloqua

    How Supplied

    Influenza A Virus A/Hawaii/66/2019 (H1N1) Live (Attenuated) antigen, Influenza A Virus A/Hong Kong/2671/2019 (H3N2) Live (Attenuated) antigen, Influenza B Virus B/Phuket/3073/2013 Live (Attenuated) antigen, Influenza B Virus B/Washington/02/2019 Live (Attenuated) antigen Nasal spray, suspension

    FluMist 2020-2021 Formula Nasal Spray (66019-0307) (MedImmune Inc, an AstraZeneca Company) nullFluMist 2020-2021 Formula Nasal Spray package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Nasal spray, suspension

    FluMist 2015-2016 Formula Nasal Spray (66019-0302) (MedImmune Inc, an AstraZeneca Company) (off market)FluMist 2015-2016 Formula Nasal Spray package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Nasal spray, suspension

    FluMist 2016-2017 Formula Nasal Spray (66019-0303) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Phuket 3073/2013 antigen, Influenza B Virus Brisbane 60/2008 antigen Nasal spray, suspension

    FluMist 2017-2018 Formula Nasal Spray (66019-0304) (MedImmune Inc, an AstraZeneca Company) (off market)FluMist 2017-2018 Formula Nasal Spray package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Yamagata 16/88 antigen, Influenza B Virus Victoria 2/87 antigen lineages Nasal spray, suspension

    FluMist 2013-2014 Formula Nasal Spray (66019-0300) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Yamagata 16/88 antigen, Influenza B Virus Victoria 2/87 antigen lineages Nasal spray, suspension

    FluMist 2014-2015 Formula Nasal Spray (66019-0301) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Yamagata 16/88 antigen, Influenza B Virus Victoria 2/87 antigen lineages Nasal spray, suspension

    FluMist 2018-2019 Formula Nasal Spray (66019-0305) (MedImmune Inc, an AstraZeneca Company) (off market)FluMist 2018-2019 Formula Nasal Spray package photo

    Influenza A Virus H1N1 antigen, Influenza A Virus H3N2 antigen, Influenza B Virus Yamagata 16/88 antigen, Influenza B Virus Victoria 2/87 antigen lineages Nasal spray, suspension

    FluMist 2019-2020 Formula Nasal Spray (66019-0306) (MedImmune Inc, an AstraZeneca Company) nullFluMist 2019-2020 Formula Nasal Spray package photo

    Influenza Virus Attenuated Live Trivalent Vaccine Nasal spray, solution

    FluMist 2004-2005 Formula Nasal Spray (66019-0101) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza Virus Attenuated Live Trivalent Vaccine Nasal spray, solution

    FluMist 2009-2010 Formula Nasal Spray (66019-0107) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza Virus Attenuated Live Trivalent Vaccine Nasal spray, solution

    FluMist 2011-2012 Formula Nasal Spray (66019-0109) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza Virus Attenuated Live Trivalent Vaccine Nasal spray, solution

    FluMist 2007-2008 Formula Nasal Spray (66019-0105) (MedImmune Inc, an AstraZeneca Company) (off market)

    Influenza Virus Attenuated Live Trivalent Vaccine Nasal spray, suspension

    FluMist 2012-2013 Formula Nasal Spray (66019-0110) (MedImmune Inc, an AstraZeneca Company) (off market)

    Description/Classification

    Description

    NOTE: The 2020/2021 trivalent vaccine virus strains for egg-based vaccines are an A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus, an A/HongKong/2671/2019 (H3N2)-like virus, and a B/Washington/02/2019-like virus (B/Victoria lineage). In addition to these virus strains, the 2020/2021 quadrivalent virus vaccine contains a B/Phuket/3073/2013-like virus (B/Yamagata lineage).[65686]

     

    Quadrivalent live-attenuated influenza vaccine (LAIV4) is a liquid, cold-adapted vaccine containing live-attenuated influenza viruses that are administered as a nasal spray. Intranasal administration stimulates localized mucosal antibody formation, and because the vaccine contains attenuated viruses, an adjuvant to enhance antigen immunogenicity is not needed.[52656] The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommends annual flu vaccination with an age-appropriate influenza vaccine (i.e., inactivated influenza vaccine (IIV), quadrivalent recombinant influenza vaccine (RIV4), or LAIV4), without preference of 1 product or formulation over another, for everyone 6 months and older.[63327] [63436] [63520] The LAIV4 may not be appropriate for patients with immunosuppression. The IIV is preferred over the LAIV4 for vaccinating household members, health-care workers, and others who have close contact with severely immunosuppressed persons during periods when such persons require care in a protected environment. The duration of influenza vaccine virus replication and shedding after LAIV4 administration is unknown. As a precautionary measure, recipients of LAIV4 should avoid close contact with severely immunosuppressed persons for 7 days after vaccination.[63436] [63520]

     

    Updates for coronavirus disease 2019 (COVID-19):

    The 2020-21 influenza season will coincide with the continued or recurrent circulation of SARS-CoV-2. Influenza vaccination of patients 6 months and older may reduce symptoms that might be confused with those of COVID-19. Additionally, prevention and reduction of influenza severity could decrease hospitalizations and intensive care unit admissions and alleviate stress on the health care system.[63436]

    Classifications

    • General Anti-infectives Systemic
      • Vaccines
        • Pure Vaccines
          • Influenza Vaccines
    Revision Date: 03/19/2021, 09:36:54 AM

    References

    52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.63327 - Centers for Disease Control and Prevention (CDC). Update: ACIP recommedations for the use of quadrivalent live attenuated influenza vaccine (LAIV4) - United States, 2018-19 influenza season. MMWR 2018; 67; 643-645.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e202002458865686 - U.S. Food & Drug Administration. Influenza vaccine for the 2021-2022 season. https://www.fda.gov/vaccines-blood-biologics/lot-release/influenza-vaccine-2020-2021-season?utm_campaign=What%27sNew2020-07-02&utm_medium=email&utm_source=Eloqua

    Administration Information

    General Administration Information

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

     

    • Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. Ask potential vaccine recipients about allergies, especially to eggs. Epinephrine injection or a comparable treatment must be readily available.
    • Prior to the administration of the intranasal influenza vaccine, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer.
    • According to U.S. federal laws, the health care provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.

    Route-Specific Administration

    Topical Administration

    Other Topical Formulations

    Intranasal Administration

    • Administer intranasally only. Do not administer parenterally.
    • Visually inspect the vaccine before administration. The vaccine should be colorless to a pale yellow that is clear to slightly cloudy.
    • Check the expiration date on the sprayer label.
    • Remove the rubber tip protector. Do not remove the dose-divide clip at the other end of the sprayer.
    • The vaccine recipient needs to be in the upright position. Place the sprayer tip just inside the nostril and depress the plunger as rapidly as possible to administer half of the dose (0.1 mL). Remove the dose-divider clip and spray the remaining dose (0.1 mL) into the other nostril. The total dose will be 0.2 mL.
    • Active inhalation (i.e., sniffing) is not required by the patient during administration.[52656]
    • If the vaccine recipient sneezes after administration, do not repeat the dose.[55936]
    • Each 0.2 mL sprayer is for single-use only. Throw away the used nasal sprayer in an approved biohazard waste container.
    • Storage: Store in a refrigerator between 2 to 8 degrees C (35 to 46 degrees F) upon receipt. Do not freeze. Keep sprayer in carton to protect from light. A single temperature excursion up to 25 degrees C for 12 hours has been shown to have no adverse impact on the vaccine. After a temperature excursion, the vaccine should be returned immediately to the recommended storage condition (2 to 8 degrees C) and used as soon as feasible. Subsequent excursions are not permitted.[52656]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
      Revision Date: 04/28/2017, 10:05:18 PM

      References

      52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.55936 - Centers for Disease Control and Prevention (CDC). Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, 2013-2014. MMWR. 2013 Sept;62 (7):1-43.

      Adverse Reactions

      Mild

      • abdominal pain
      • anorexia
      • chills
      • cough
      • diarrhea
      • fever
      • headache
      • irritability
      • lethargy
      • myalgia
      • nasal congestion
      • nausea
      • rash
      • rhinorrhea
      • sinusitis
      • sneezing
      • urticaria
      • vomiting
      • weakness

      Severe

      • anaphylactic shock
      • anaphylactoid reactions
      • angioedema
      • bronchospasm
      • Guillain-Barre syndrome
      • pericarditis

      Moderate

      • meningitis
      • wheezing

      Adverse reactions associated with administration of the intranasal influenza vaccine are usually mild. Adverse reactions in adults and children include nasal congestion (9% to 58%), rhinorrhea (44% to 58%), sneezing (2%), sore throat (5% to 28%), irritability (12% to 21%), headache (3% to 40%), lethargy (6% to 14%), weakness (26%), sinusitis (4%), fever (more than 100 degrees F, (7% to 16%), myalgia (2% to 17%), anorexia (13% to 21%), abdominal pain (2% to 12%), chills (2% to 9%), and cough (14%). More patients who received the vaccine than those who received placebo had otitis media (3% vs. 1%, respectively). Asthma attacks or wheezing symptoms have been reported. Rarely, immediate allergic reactions occur after influenza vaccination in all populations. An allergic reaction may present as urticaria, rash, angioedema, bronchospasm, and/or anaphylactic shock; these reactions are most likely the result of hypersensitivity to residual egg protein. Postmarketing, hypersensitivity reactions including anaphylactoid reactions, facial edema, and urticaria have been reported. Pericarditis, meningitis, eosinophilic meningitis, vaccine-associated encephalitis, nausea, vomiting, and diarrhea have also been reported postmarketing.[48603] [52656]

      No cases of Guillain-Barre syndrome (GBS) have been reported with the intranasal influenza vaccine. However, an increased risk of developing GBS after administration of the inactivated influenza virus vaccine was evident in 1976. Subsequent influenza vaccinations during the next few years were not associated with this increased risk. However, during 1993 to 94 twice the average yearly rate (for the period 1990 to 95) of influenza vaccine-associated incidences of GBS were reported, representing a risk of slightly more than 1 additional case of GBS per million persons vaccinated. In most cases, symptoms were limited and reversible, but fatalities have occurred. Persons with a history of GBS have a substantially greater likelihood of subsequently developing GBS than persons without such a history. Thus, the likelihood of coincidentally developing GBS after influenza vaccination is expected to be greater among persons with a history of GBS than among persons with no history of this syndrome. It is not known if influenza vaccination is causally associated with this risk for recurrence of GBS.[48603] [52656]

      Revision Date: 07/29/2020, 12:08:31 PM

      References

      48603 - FluMist trivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2012 Jul.52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • egg hypersensitivity
      • Reye's syndrome
      • severe combined immunodeficiency (SCID)
      • acquired immunodeficiency syndrome (AIDS)
      • agammaglobulinemia
      • aminoglycoside hypersensitivity
      • asplenia
      • asthma
      • breast-feeding
      • cardiac disease
      • chemotherapy
      • children
      • chronic lung disease (CLD)
      • chronic obstructive pulmonary disease (COPD)
      • cochlear implant
      • cranial cerebrospinal fluid leak
      • cystic fibrosis
      • diabetes mellitus
      • fever
      • gelatin hypersensitivity
      • geriatric
      • Guillain-Barre syndrome
      • hemoglobinopathy
      • hepatic disease
      • human immunodeficiency virus (HIV) infection
      • hypogammaglobulinemia
      • IgA deficiency
      • immunosuppression
      • infants
      • infection
      • leukemia
      • lymphoma
      • multiple sclerosis
      • neonates
      • neoplastic disease
      • neuromuscular disease
      • pregnancy
      • radiation therapy
      • renal failure
      • respiratory infection
      • seizure disorder
      • sickle cell disease

      Prior to administration, inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986.[52653] If a dose of influenza vaccine has been previously given, question the patient, parent, or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.[52656]

      The decision to administer or to delay vaccination with the intranasal influenza virus vaccine because of current febrile illness depends on the severity of symptoms and the etiology of the disease. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during a moderate or severe acute febrile illness unless the patient is at immediate risk of infection; administer the vaccine as soon as possible after the acute phase of illness has resolved. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. However, if nasal congestion is present that might impede delivery of the vaccine to the nasopharyngeal mucosa, then administration of the intranasal vaccine should be deferred until the congestion has resolved or the inactivated influenza vaccine should be used.[43236] Allergic rhinitis does not preclude intranasal influenza vaccine administration. There are no data regarding concurrent intranasal corticosteroid administration and the use of intranasal influenza vaccine.[52656]

      The live-attenuated influenza vaccine (LAIV4) is contraindicated in individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine or any of its components or persons who have had life-threatening reactions to any previous influenza vaccination. The FDA-approved product labeling states that LAIV4 is also contraindicated in patients with egg hypersensitivity because these vaccines are prepared using embryonated chicken eggs.[52656] The Advisory Committee on Immunization Practices (ACIP) recommends administering any licensed, age-appropriate influenza vaccine (i.e., inactivated influenza vaccine (IIV), quadrivalent recombinant influenza vaccine (RIV4), or LAIV4) to patients with egg allergy of any severity. Patients who have had symptoms other than urticaria after egg exposure (i.e., angioedema, respiratory distress, lightheadedness, or recurrent emesis) or required emergency medical intervention, may also receive any licensed, age-appropriate influenza vaccine; however, it is recommended that the vaccine only be administered in an inpatient or outpatient medical setting by a health care provider experienced in the recognition and management of severe allergic conditions. Severe allergic reactions to vaccines can occur in patients without a history of previous allergic reaction. A previous severe allergic reaction to influenza vaccine is a contraindication to receiving future influenza vaccines. Although no specific observation time is recommended for egg-allergic patients, ACIP recommends patients be observed for syncope for 15 minutes after vaccination.[53026] [63436] The American Academy of Pediatrics (AAP), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI) do not recommend any special precautions for egg-allergic recipients, regardless of severity. The AAAAI and ACAAI consider any special precautions (i.e., special observation periods or administration in a specialized medical setting) unnecessary due to the extremely rare risk of anaphylactic reactions after vaccination. They recommend that providers and screening questionnaires not ask about the egg allergy status of the influenza virus vaccine recipient.[62809] [63520] Each 0.2 mL LAIV4 dose contains 2 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, and less than 0.015 mcg/mL gentamicin sulfate. Patients with gelatin hypersensitivity, arginine hypersensitivity, or aminoglycoside hypersensitivity may be inappropriate candidates for LAIV4 receipt. As with any biologic product, the prescriber or health care professional should have procedures in place to manage allergic reactions. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the intranasal influenza vaccine.[52656]

      The intranasal influenza vaccine is not absorbed systemically after intranasal administration and use during pregnancy is not expected to result in fetal exposure to the drug. However, adequate and well-controlled studies have not been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with intranasal influenza vaccine.[52656] According to the Advisory Committee on Immunization Practices (ACIP), administration of live vaccines to pregnant women should be avoided. However, because pregnancy may increase the risk of serious medical complications from influenza, the ACIP recommends that all women who are pregnant or will be pregnant (in any trimester) during influenza season be routinely vaccinated with an inactivated influenza virus vaccine.[63436]

      According to the CDC, live-virus vaccines administered to a lactating woman do not affect the safety of breast-feeding for women or their infants. Although live viruses in vaccines can replicate in vaccine recipients (i.e., the mother), the majority of live viruses in vaccines have been demonstrated not to be excreted in human milk. If infection does occur, it is well tolerated because the virus is attenuated. There are no data to suggest that passive transfer of antibodies in human milk can affect the efficacy of live-virus vaccines. Breastfed infants should be vaccinated according to the recommended schedule.[43236] The manufacturer recommends caution when administering to nursing mothers.[52656] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

      The intranasal influenza vaccine is a live vaccine, and live vaccines are contraindicated in patients with severe combined immunodeficiency (SCID). The intranasal influenza vaccine has not been evaluated in patients with other forms of immunosuppression (i.e., IgA deficiency, hypogammaglobulinemia, agammaglobulinemia, or dysgammaglobulinemia) and use in these patients is not recommended.[43236] The vaccine should not be used in patients with anatomical or functional asplenia, anyone with cranial cerebrospinal fluid leak, or cochlear implant. Patients with cochlear implants are at risk for cerebrospinal (CSF) leak for a period after implantation. The intranasal influenza vaccine should also not be administered to those with cellular immune deficiency or those patients on immunosuppressive therapy such as high-dose corticosteroid therapy. However, corticosteroid therapy usually is not a contraindication to administering live-virus vaccines when administration is short-term (less than 2 weeks); a low-to-moderate dose (less than 2 mg/kg of body weight or 20 mg/day of prednisone or equivalent for persons who weigh more than 10 kg when administered for less than 2 weeks); long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or when administered topically (skin, eyes), inhaled, or by local injection. Healthcare providers should wait at least 1 month after discontinuation of high-dose corticosteroid therapy given for more than 2 weeks before administering the intranasal influenza vaccine.[43236] [53026] [63436] [63520]

      The live-attenuated influenza vaccine (LAIV4) is not the preferred agent for use in patients with a history of asthma or reactive airway disease, particularly pediatric patients younger than 5 years old with recurrent wheezing, due to the increased risk of wheezing after administration; weigh the potential benefit against the potential risk. In a placebo-controlled safety study, an increase in asthma events was observed among patients younger than 5 years of age. Do not administer LAIV4 to patients with severe asthma or active wheezing because these individuals have not been studied in clinical trials.[52656] The inactivated influenza virus vaccine is the recommended product for patients with asthma or a history of wheezing in the past 12 months (for pediatric patients ages 2 to younger than 5 years).[63436]

      The live-attenuated influenza vaccine is not indicated for use in geriatric patients; the vaccine is only indicated for patients 2 to 49 years of age. The effectiveness of the vaccine was not demonstrated in a clinical trial with a subgroup of patients 50 to 64 years of age.[52656]

      Neonates, infants, and children younger than 2 years of age should not receive the quadrivalent live-attenuated influenza vaccine (LAIV4). In clinical trials, an increased risk of wheezing, that required bronchodilator therapy or was associated with significant respiratory symptoms within 6 weeks of vaccination, and hospitalization (for any cause within 6 months) was observed among pediatric patients younger than 2 years who received LAIV4 (5.9% and 4.2%, respectively) compared with those who received inactivated influenza vaccine (3.8% and 3.2%, respectively). The inactivated influenza virus vaccine should be used to vaccinate infants and children 6 months to 2 years of age. In addition, children younger than 5 years of age with recurrent wheezing may be at increased risk for wheezing after administration of the intranasal influenza vaccine. LAIV4 is contraindicated in children and adolescents up to 17 years of age receiving salicylate therapy (e.g., aspirin or aspirin-containing therapy). The intranasal influenza vaccine is a live vaccine, and thus could potentially result in influenza infection and in the development of Reye's syndrome in these patients.[52656]

      Carefully consider the potential benefits and risks of the live-attenuated influenza vaccine (LAIV4) for patients who have developed Guillain-Barre syndrome (GBS) within 6 weeks of a previous influenza vaccination.[52656] Persons with a history of GBS have a substantially greater likelihood of subsequently developing GBS than persons without such a history. It is not known whether influenza vaccination is causally associated with this risk for recurrence of GBS. Nevertheless, as a precaution, the ACIP generally recommends against influenza immunization in patients who have developed GBS within 6 weeks of a previous influenza vaccination. However, for most persons with a history of GBS who are at high risk for severe complications from influenza, many experts believe the benefits of the influenza virus vaccine justify yearly vaccination.[63436]

      The safety of the quadrivalent live-attenuated influenza vaccine (LAIV4) in individuals with underlying medical conditions that may predispose them to complications after wild-type influenza infection (e.g., chronic pulmonary, including chronic obstructive pulmonary disease (COPD), cardiovascular, renal, metabolic, neurologic, hematologic, or hepatic disease) has not been established; only administer the LAIV4 if the potential benefit outweighs the potential risk.[52656] [63436] The American Academy of Pediatrics specifically recommends the use of the inactivated influenza virus vaccine for all pediatric patients with the following conditions: asthma; chronic pulmonary diseases, including chronic lung disease (CLD) and cystic fibrosis; hemodynamically significant cardiac disease; immunosuppressive disorders, including HIV infection; sickle cell disease or other hemoglobinopathy; chronic renal dysfunction (e.g., renal failure); chronic metabolic disease (e.g., diabetes mellitus); conditions that require long-term aspirin therapy, such as juvenile idiopathic arthritis or Kawasaki disease; and any condition that can compromise respiratory function or handling of secretions (e.g., neuromuscular disease such as multiple sclerosis, seizure disorder, spinal cord injuries, neurodevelopmental disorders).[63520]

      The efficacy of the intranasal influenza vaccine has not been established in patients with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). The guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV considers use of the live attenuated influenza vaccine (LAIV) administered via the nasal route as contraindicated in patients with HIV.[34362] The live virus vaccine theoretically could cause serious influenza infection in these patients. However, among 28 adult patients with HIV infection (median CD4 count of 541 cells/mm3), no serious adverse reactions were reported during the 4 weeks after vaccine receipt. Vaccine strain (type B) virus was detected in 1 of 28 HIV-infected subjects on Day 5 only.[52656] The CDC recommends immunization of HIV-infected individuals with the inactivated influenza vaccine, as this measure is safe and may confer protection against influenza.[63436] [63520]

      The intranasal influenza vaccine is not recommended in patients with neoplastic disease that causes bone marrow suppression or affects the lymphatic system such as leukemia or lymphoma, including patients currently receiving chemotherapy or radiation therapy. Patients with leukemia, lymphoma, or other malignancies whose disease is in remission and whose chemotherapy or radiation therapy has been terminated for at least 3 months can receive live-virus vaccines. The intranasal influenza vaccine is also not recommended for close contacts of severely immunosuppressed persons who require a protected environment.[43236] [53026]

      Revision Date: 06/30/2021, 02:32:49 PM

      References

      34362 - Panel on 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 Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Accessed July 1, 2021. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Adult_OI.pdf43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.52653 - National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 to 300aa-34). Retrieved from the World Wide Web December 18, 2012. http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf.52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.53026 - Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years and adults aged 19 years and older-United States, 2021. MMWR 2021;70(6):189-196.62809 - Greenhawt M, Turner PJ, Kelso JM. Administration of influenza vaccines to egg allergic recipients: A practice parameter update 2017. Ann Allergy Asthma Immunol 2018; 120: 49-52.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63520 - American Academy of Pediatrics Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2020-2021. Pediatrics. 2020;146(4):e2020024588

      Mechanism of Action

      The immune mechanisms that confer protection from influenza infection have not been fully elucidated. Intranasal influenza vaccine imparts immunity against the influenza virus by stimulating production of antibodies that are specific to the disease. Influenza strain-specific serum antibodies to the vaccine have been demonstrated. The intranasal route of administration also stimulates localized mucosal antibody formation and may enhance cytotoxic T-cell formation. In general, patients who receive the vaccine will be immune only to those strains of the virus from which the vaccine was prepared. In one clinical study, protection was afforded against an H3N2 strain that was not well-matched to the H3N2 strain contained in the virus, suggesting that the vaccine provided cross-protection against the variant strain.[27509]

       

      Influenza viruses are recognized by the surface antigens they carry, and two such antigens, hemagglutinin (H) and neuraminidase (N) have been identified and are used to classify the various viruses. Subtypes of these strains (H1, H2, H3, N1, N2) are associated with influenza A virus and have been recognized to cause disease in humans. Immunity to these surface antigens increases resistance to infection and decreases the severity of the disease if infection occurs. Eventually, antigenic variation can occur, and immunity to one strain may no longer impart immunity to distantly related subtypes of the virus. Influenza B viruses also exhibit antigenic variation, and new variants of both types of viruses continue to cause widespread epidemics of respiratory disease.

       

      The intranasal influenza vaccine is attenuated and thus, will not produce classic influenza-like illness. However, as the product is a live vaccine, some flu-like symptoms may occur shortly after vaccine receipt.

      Revision Date: 12/19/2012, 02:42:07 PM

      References

      27509 - Nichol KL, Mendelman PM, Mallon KP, et al. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA 1999;282:137-44.

      Pharmacokinetics

      The intranasal influenza vaccine is administered topically as a fine mist to the inside of the nose. Most of the dose is deposited in the nose and nasopharynx. Post-vaccine antibody titers are generally high enough in healthy young adults and children to provide resistance against infection by influenza virus strains found in the vaccine as well as related strains. The duration of immunity imparted by the intranasal influenza vaccine is unknown; annual revaccination is needed. Influenza may be transmitted by the vaccine recipient to others. The frequency and duration of viral shedding after vaccine receipt have not been established. At least one vaccine strain was recovered from 80% of 98 FluMist recipients during the monitoring period, which was the first 21 days after vaccine receipt. The mean duration of vaccine strain detection was 7.6 +/- 3.4 days.

      Revision Date: 01/28/2010, 01:23:03 PM

      Pregnancy/Breast-feeding

      pregnancy

      The intranasal influenza vaccine is not absorbed systemically after intranasal administration and use during pregnancy is not expected to result in fetal exposure to the drug. However, adequate and well-controlled studies have not been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect reproductive capacity is unknown. During animal studies, no evidence of impaired fertility or fetal harm was noted with intranasal influenza vaccine.[52656] According to the Advisory Committee on Immunization Practices (ACIP), administration of live vaccines to pregnant women should be avoided. However, because pregnancy may increase the risk of serious medical complications from influenza, the ACIP recommends that all women who are pregnant or will be pregnant (in any trimester) during influenza season be routinely vaccinated with an inactivated influenza virus vaccine.[63436]

      breast-feeding

      According to the CDC, live-virus vaccines administered to a lactating woman do not affect the safety of breast-feeding for women or their infants. Although live viruses in vaccines can replicate in vaccine recipients (i.e., the mother), the majority of live viruses in vaccines have been demonstrated not to be excreted in human milk. If infection does occur, it is well tolerated because the virus is attenuated. There are no data to suggest that passive transfer of antibodies in human milk can affect the efficacy of live-virus vaccines. Breastfed infants should be vaccinated according to the recommended schedule.[43236] The manufacturer recommends caution when administering to nursing mothers.[52656] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

      Revision Date: 03/18/2021, 04:33:39 PM

      References

      43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.52653 - National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 to 300aa-34). Retrieved from the World Wide Web December 18, 2012. http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf.52656 - FluMist quadrivalent (influenza vaccine live, intranasal) package insert. Gaithersburg, MD: MedImmune, LLC.; 2021 Aug.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.

      Interactions

      Level 1 (Severe)

      • Abatacept
      • Adalimumab
      • Aldesleukin, IL-2
      • Alefacept
      • Alemtuzumab
      • Alkylating agents
      • Alpha interferons
      • Altretamine
      • Antimetabolites
      • Antithymocyte Globulin
      • Axicabtagene Ciloleucel
      • Azathioprine
      • Basiliximab
      • Belatacept
      • Bexarotene
      • Blinatumomab
      • Brexucabtagene Autoleucel
      • Busulfan
      • Carmustine, BCNU
      • Certolizumab pegol
      • Chlorambucil
      • Cisplatin
      • Clofarabine
      • Cortisone
      • Cyclosporine
      • Cytarabine, ARA-C
      • Dacarbazine, DTIC
      • Daclizumab
      • Deflazacort
      • Dexamethasone
      • Docetaxel
      • Estramustine
      • Etanercept
      • Everolimus
      • Fingolimod
      • Floxuridine
      • Fludrocortisone
      • Fluorouracil, 5-FU
      • Folate analogs
      • Golimumab
      • Hydrocortisone
      • Idecabtagene Vicleucel
      • Ifosfamide
      • Imatinib
      • Infliximab
      • Ixabepilone
      • Leflunomide
      • Lenalidomide
      • Lisocabtagene Maraleucel
      • Lomustine, CCNU
      • Mechlorethamine, Nitrogen Mustard
      • Melphalan
      • Melphalan Flufenamide
      • Methylprednisolone
      • Mitoxantrone
      • Mycophenolate
      • Natalizumab
      • Nelarabine
      • Nilotinib
      • Obinutuzumab
      • Paclitaxel
      • Ponesimod
      • Prednisolone
      • Prednisone
      • Procarbazine
      • Purine analogs
      • Rilonacept
      • Rituximab
      • Rituximab; Hyaluronidase
      • Siltuximab
      • Sirolimus
      • Streptozocin
      • Tacrolimus
      • Temozolomide
      • Temsirolimus
      • Thiotepa
      • Tisagenlecleucel
      • Tositumomab
      • Triamcinolone
      • Ustekinumab
      • Vincristine
      • Vincristine Liposomal
      • Vinorelbine

      Level 2 (Major)

      • Amantadine
      • Anakinra
      • Baloxavir Marboxil
      • Baricitinib
      • Belimumab
      • Brodalumab
      • Canakinumab
      • Dupilumab
      • Emapalumab
      • Guselkumab
      • Inebilizumab
      • Interferon Gamma-1b
      • Ixekizumab
      • Ocrelizumab
      • Ofatumumab
      • Oseltamivir
      • Ozanimod
      • Peramivir
      • Risankizumab
      • Sarilumab
      • Satralizumab
      • Secukinumab
      • Siponimod
      • Teriflunomide
      • Tildrakizumab
      • Tocilizumab
      • Tofacitinib
      • Vedolizumab
      • Venetoclax
      • Voclosporin
      • Zanamivir
      Abatacept: (Contraindicated) If possible, administer all needed vaccines before abatacept initiation. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. The immune response of the immunocompromised patient to vaccines may be decreased and adjusted doses or boosters that are more frequent may be required. The immune response to an inactive vaccine may still be suboptimal. Live virus vaccines may induce the illness they are intended to prevent and are contraindicated for use during immunosuppressive treatment. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [31761] [43236] Adalimumab: (Contraindicated) Do not administer live vaccines to adalimumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving adalimumab. Before initiation of adalimumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Adalimumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27939] [43236] Aldesleukin, IL-2: (Contraindicated) Aldesleukin, IL-2 is associated with impaired neutrophil function. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [41853] [43236] Alefacept: (Contraindicated) The safety and efficacy of administering attenuated virus vaccines or live vaccines to patients receiving alefacept have not been studied. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [49062] Alemtuzumab: (Contraindicated) Do not administer live vaccines to alemtuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving alemtuzumab. At least 6 weeks before initiation of alemtuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Alemtuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58461] Alkylating agents: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Alpha interferons: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient, including those receiving Interferon therapy. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Altretamine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Amantadine: (Major) Do not administer the intranasal live attenuated influenza vaccine (LAIV) 2 weeks before or 48 hours after administration of amantadine, unless medically indicated. Inactivated influenza vaccines may be used, as appropriate. Because of its antiviral properties, amantadine may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live influenza virus vaccines are not recommended during treatment with amantadine. Consult currently recommended guidance on the use of antiviral drugs against influenza. [28049] [46061] [62262] [62273] [62887] Anakinra: (Major) Avoid concurrent use of live vaccines during treatment with anakinra due to potentially increased risk of infections; clinical safety of live vaccines during anakinra treatment has not been established. Live virus vaccines should generally not be administered to an immunosuppressed patient, as they may induce the illness they are intended to prevent. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving anakinra. The interval between live vaccinations and initiation of anakinra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [27940] [43236] Antimetabolites: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Antithymocyte Globulin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Axicabtagene Ciloleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during axicabtagene ciloleucel therapy, and prior to immune recovery following treatment with axicabtagene ciloleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62530] [65107] Azathioprine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Baloxavir Marboxil: (Major) Do not administer the intranasal live attenuated influenza vaccine (LAIV) 2 weeks before or 17 days after administration of baloxavir, unless medically indicated. Inactivated influenza vaccines may be used, as appropriate. Because of its antiviral properties, baloxavir may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live influenza virus vaccines are not recommended during treatment with baloxavir. Consult currently recommended guidance on the use of antiviral drugs against influenza. [63436] Baricitinib: (Major) Do not administer live virus vaccines to patients taking baricitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during baricitinib receipt. Before baricitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [63229] Basiliximab: (Contraindicated) Do not administer live vaccines to basiliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving basiliximab. At least 2 weeks before initiation of basiliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Basiliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [41849] [43236] Belatacept: (Contraindicated) Avoid the use of live vaccines such as the intranasal influenza vaccine; measles/mumps/rubella vaccines, MMR; Bacillus Calmette-Guerin Live, BCG; yellow fever vaccine; oral polio vaccine; varicella virus vaccine live; and TY21a typhoid vaccine during belatacept treatment. Further, inactive vaccine receipt may not illicit an acceptable response; belatacept may blunt the effectiveness of some immunizations. Consult the most current CDC guidances for vaccination recommendations. [44667] Belimumab: (Major) Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. Because of its mechanism of action, belimumab may interfere with the response to immunizations. No data are available on the secondary transmission of infection from persons receiving live vaccines. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [43658] Bexarotene: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Blinatumomab: (Contraindicated) Do not administer live vaccines to blinatumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving blinatumomab. At least 2 weeks before initiation of blinatumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Blinatumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58559] Brexucabtagene Autoleucel : (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel therapy, and prior to immune recovery following treatment with brexucabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [65739] Brodalumab: (Major) Avoid administration of live vaccines to brodalumab recipients. Before initiation of brodalumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving brodalumab therapy. [61762] Busulfan: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Canakinumab: (Major) Do not administer live vaccines to a patient who is receiving canakinumab; other vaccination schedules should be complete as recommended prior to initiating canakinumab treatment. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving canakinumab. The immune response to vaccines or toxoids may be decreased, as canakinumab may interfere with normal immune response to new antigens. Limited data are available on the effectiveness of vaccination with inactivated antigens in patients receiving canakinumab. Because interleukin-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with canakinumab, adult and pediatric patients receive any recommended vaccination (including pneumococcal vaccine and inactivated influenza vaccines). [41378] [43236] Carmustine, BCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Certolizumab pegol: (Contraindicated) Do not administer live vaccines concurrently with certolizumab. No data are available on the response to vaccinations or to the secondary transmission of infection by live vaccines in patients receiving certolizumab. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33930] [43236] Chlorambucil: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Cisplatin: (Contraindicated) Do not administer live vaccines to cisplatin recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cisplatin. At least 2 weeks before initiation of cisplatin therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cisplatin recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28393] [43236] Clofarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system [43236] Cortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49489] Cyclosporine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Cytarabine, ARA-C: (Contraindicated) Do not administer live vaccines to cytarabine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cytarabine. At least 2 weeks before initiation of cytarabine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cytarabine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48339] Dacarbazine, DTIC: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Daclizumab: (Contraindicated) Do not administer live vaccines to daclizumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving daclizumab. At least 2 weeks before initiation of daclizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Daclizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60841] Deflazacort: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [61750] Dexamethasone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [54286] Docetaxel: (Contraindicated) Do not administer live vaccines to docetaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving docetaxel. At least 2 weeks before initiation of docetaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Docetaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58408] Dupilumab: (Major) Avoid administration of live vaccines to dupilumab recipients. Before initiation of dupilumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving dupilumab therapy. [61836] Emapalumab: (Major) Do not administer live or live attenuated vaccines to patients receiving emapalumab and for at least 4 weeks after the last dose of emapalumab. The safety of immunization with live vaccines during or after emapalumab therapy has not been studied. [63767] Estramustine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Etanercept: (Contraindicated) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune syste [28060] [29646] [43236] Everolimus: (Contraindicated) Do not administer live vaccines to everolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving everolimus. Before initiation of everolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Everolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [49823] [49903] Fingolimod: (Contraindicated) Do not administer live vaccines to a patient who is receiving fingolimod or has discontinued the drug in the last 2 months because of the risk of infection. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving fingolimod. Before fingolimod initiation, test patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) for antibodies to VZV. Consider VZV vaccination of antibody-negative patients before fingolimod initiation, and do not start fingolimod for 1 month to allow the full effect of vaccination to occur. In addition to the concerns with live virus vaccines, the immune response to inactive vaccines or toxoids may be decreased, as fingolimod may interfere with normal immune response to new antigens. No data are available on the effectiveness of vaccination with inactivated antigens in patients receiving fingolimod. Vaccination may be less effective during and for up to 2 months after fingolimod discontinuation. For example, as compared with the response of placebo recipients, the capacity to mount a skin delayed-type hypersensitivity reaction to Candida and to tetanus toxoid was decreased by approximately 30% among fingolimod 0.5 mg daily recipients. Further, in healthy patients, antigen-specific IgM titers were decreased by 25% in response to pneumococcal polysaccharide vaccine (PPV-23) immunization as compared with the response by placebo recipients. Similarly, IgG titers were decreased by 50% among fingolimod recipients as compared with placebo. [41823] [43236] Floxuridine: (Contraindicated) Do not administer live vaccines to floxuridine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving floxuridine. At least 2 weeks before initiation of floxuridine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Floxuridine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48344] Fludrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49507] Fluorouracil, 5-FU: (Contraindicated) Do not administer live vaccines to fluorouracil recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving fluorouracil. At least 2 weeks before initiation of fluorouracil therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Fluorouracil recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [53824] Folate analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Golimumab: (Contraindicated) Do not administer live vaccines to golimumab recipients. Limited data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [35501] [43236] Guselkumab: (Major) Avoid use of live vaccines in patients being treated with guselkumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving guselkumab. In addition, guselkumab may decrease the vaccine-induced immune response. Before initiation of guselkumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. [62120] Hydrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [32057] [43236] [54049] Idecabtagene Vicleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel therapy, and prior to immune recovery following treatment with idecabtagene vicleucell. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] Ifosfamide: (Contraindicated) Do not administer live vaccines to ifosfamide recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving ifosfamide. Before initiation of ifosfamide therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Ifosfamide recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [51027] Imatinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Inebilizumab: (Major) Administer all immunizations according to immunization guidelines at least 4 weeks before initiation of inebilizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. In a neonate or infant with in utero exposure to inebilizumab, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in the exposed infant may increase the risks from live or live-attenuated vaccines. [43236] [60092] [65576] Infliximab: (Contraindicated) Do not administer live vaccines to infliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving infliximab. Before initiation of infliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Infliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27994] [43236] Interferon Gamma-1b: (Major) Avoid the concomitant use of interferon gamma-1b with other immunological preparations such as live vaccines due to the risk of an unpredictable or amplified, immune response. [49610] Ixabepilone: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Ixekizumab: (Major) Do not administer live vaccines to ixekizumab recipients. Before initiation of ixekizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving Ixekizumab therapy. [60658] Leflunomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [49634] Lenalidomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Lisocabtagene Maraleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during lisocabtagene maraleucel therapy, and prior to immune recovery following treatment with lisocabtagene maraleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [66383] Lomustine, CCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Mechlorethamine, Nitrogen Mustard: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Melphalan Flufenamide: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Melphalan: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Methylprednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [41361] [43236] Mitoxantrone: (Contraindicated) Do not administer live vaccines to mitoxantrone recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mitoxantrone. At least 2 weeks before initiation of mitoxantrone therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mitoxantrone recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48215] Mycophenolate: (Contraindicated) Do not administer live vaccines to mycophenolate recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mycophenolate. At least 2 weeks before initiation of mycophenolate therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mycophenolate recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27985] [43236] Natalizumab: (Contraindicated) The immune response to vaccines or toxoids may be decreased in patients who receive natalizumab; however, no data are available. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [30470] [43236] Nelarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Nilotinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Obinutuzumab: (Contraindicated) Do not administer live vaccines to obinutuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving obinutuzumab. Before initiation of obinutuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Obinutuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56353] Ocrelizumab: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. [43236] [60092] [61838] (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. [43236] [61838] Ofatumumab: (Major) Administer all live and live-attenuated vaccines according to immunization guidelines at least 4 weeks before initiation of ofatumumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with ofatumumab; wait until B-cell recovery occurs after discontinuation of ofatumumab before administering these vaccines to a patient. [43236] [60092] [65850] (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion. [43236] [60092] [65850] Oseltamivir: (Major) Do not administer intranasal live attenuated influenza vaccine (LAIV) 2 weeks before or 48 hours after administration of oseltamivir, unless medically indicated. Inactivated influenza vaccines may be used, as appropriate. Because of its antiviral properties, oseltamivir may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live influenza virus vaccines are not recommended during treatment with oseltamivir. Consult currently recommended guidance on the use of antiviral drugs against influenza. [31109] [63436] Ozanimod: (Major) Avoid the use of live vaccines and live attenuated vaccines during ozanimod treatment and for up to 3 months after discontinuation of ozanimod treatment. Live vaccinations may be less effective during ozanimod treatment and also may carry the risk of infection. [65169] Paclitaxel: (Contraindicated) Do not administer live vaccines to paclitaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving paclitaxel. At least 2 weeks before initiation of paclitaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Paclitaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29200] [43236] Peramivir: (Major) Do not administer the intranasal live attenuated influenza vaccine (LAIV) 2 weeks before or 5 days after administration of peramivir, unless medically indicated. Inactivated influenza vaccines may be used, as appropriate. Because of its antiviral properties, peramivir may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live influenza virus vaccines are not recommended during treatment with peramivir. Consult currently recommended guidance on the use of antiviral drugs against influenza. [58671] [63436] Ponesimod: (Contraindicated) The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ponesimod treatment and for 1 to 2 weeks after discontinuation of treatment with ponesimod. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ponesimod treatment. [60092] [65107] [66527] Prednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43740] [45339] Prednisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43319] Procarbazine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Purine analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Rilonacept: (Contraindicated) Do not administer live vaccines to a patient who is receiving rilonacept. No data are available regarding the use of live vaccines during rilonacept treatment. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33837] [43236] Risankizumab: (Major) Avoid administration of live vaccines to risankizumab recipients. Before initiation of risankizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving risankizumab therapy. [64073] Rituximab: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Rituximab; Hyaluronidase: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Sarilumab: (Major) Avoid concurrent use of live vaccines during treatment with sarilumab due to potentially increased risk of infections; clinical safety of live vaccines during sarilumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving sarilumab. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [51778] [61976] Satralizumab: (Major) Administer all live vaccines according to immunization guidelines at least 4 weeks before initiation of satralizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with satralizumab. [43236] [60092] [65841] (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab. [43236] [60092] [65841] Secukinumab: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab. [58739] Siltuximab: (Contraindicated) Do not administer live vaccines to siltuximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving siltuximab. Before initiation of siltuximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Siltuximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57062] Siponimod: (Major) Avoid the use of live vaccines during treatment with siponomid and for 4 weeks after stopping treatment due to the risk of secondary infection. Additionally, vaccines may be less effective if administered during siponimod treatment and for 4 weeks after siponimod treatment discontinuation. [64031] (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment. [64031] Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28610] [43236] Streptozocin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tacrolimus: (Contraindicated) Do not administer live vaccines to tacrolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tacrolimus. At least 2 weeks before initiation of tacrolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tacrolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60497] Temozolomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Temsirolimus: (Contraindicated) The use of live vaccines should be avoided during treatment with temsirolimus. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33280] [43236] Teriflunomide: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during teriflunomide use, concomitant vaccination with live vaccines is not recommended. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping the medication if the teriflunomide drug elimination procedure has not been performed. [51794] Thiotepa: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tildrakizumab: (Major) Avoid administration of live vaccines to tildrakizumab recipients. Before initiation of tildrakizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving tildrakizumab therapy. [62970] Tisagenlecleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel therapy, and prior to immune recovery following treatment with tisagenlecleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62282] [65107] Tocilizumab: (Major) Avoid concurrent use of live vaccines during treatment with tocilizumab due to potentially increased risk of infections; clinical safety of live vaccines during tocilizumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [38283] [51778] Tofacitinib: (Major) Do not administer live virus vaccines to patients taking tofacitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during tofacitinib receipt. Before tofacitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [52315] Tositumomab: (Contraindicated) Do not administer live vaccines to tositumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tositumomab. At least 2 weeks before initiation of tositumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tositumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [55836] Triamcinolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [56146] Ustekinumab: (Contraindicated) If possible, administer all recommended vaccines before ustekinumab initiation. Ustekinumab recipients may receive inactive vaccines, but the elicited immune response may be insufficient to prevent disease. Do not administer live vaccines to a ustekinumab recipient. Furthermore, do not administer BCG live vaccines for either 1 year before or 1 year after ustekinumab receipt, due to the infectious risk for Mycobacteria. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration of other live vaccines to ustekinumab recipients. Cautious administration of ustekinumab to household contacts of ustekinumab recipients may be warranted due to the potential risk for shedding from the household contact and transmission to the patient. Practitioners should also refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [36889] [43236] Vedolizumab: (Major) Avoid administering live vaccines to vedolizumab recipients unless the benefits outweigh the risks; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vedolizumab. Before initiation of vedolizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vedolizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57235] Venetoclax: (Major) Avoid live vaccines to venetoclax recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving venetoclax. Before initiation of venetoclax therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Venetoclax recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60706] Vincristine Liposomal: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vincristine: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vinorelbine: (Contraindicated) Do not administer live vaccines to vinorelbine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vinorelbine. Before initiation of vinorelbine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vinorelbine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56871] Voclosporin: (Major) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [66336] Zanamivir: (Major) Do not administer the intranasal live attenuated influenza vaccine (LAIV) 2 weeks before or 48 hours after administration of zanamivir, unless medically indicated. Inactivated influenza vaccines may be used, as appropriate. Because of its antiviral properties, zanamivir may interfere with the efficacy of live attenuated influenza vaccines. Therefore, live influenza virus vaccines are not recommended during treatment with zanamivir. Consult currently recommended guidance on the use of antiviral drugs against influenza. [35421] [63436]
      Revision Date: 06/04/2021, 02:29:00 AM

      References

      27939 - Humira (adalimumab) package insert. North Chicago, IL: AbbVie Inc; 2021 Feb.27940 - Kineret (anakinra) package insert. Stockholm, Sweden: Swedish Orphan Biovitrum AB; 2018 Jun.27985 - CellCept (mycophenolate mofetil) package insert. South San Francisco, CA: Genentech USA, Inc.; 2019 Dec.27994 - Remicade (infliximab) package insert. Horsham, PA: Janssen Biotech, Inc.; 2020 May.28049 - Amantadine HCl capsules package insert. Princeton, NJ: Sandoz Inc; 2015 May.28060 - Enbrel (etanercept injection) package insert. Thousand Oaks, CA: Amgen; 2020 Aug.28393 - Platinol (cisplatin) for injection package insert. Paramus, NJ: WG Critical Care, LLC; 2019 Feb.28610 - Rapamune (sirolimus) package insert. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2019 Aug.29025 - Rituxan (rituximab) injection package insert. South San Francisco, CA: Genentech, Inc.; 2021 June.29200 - Taxol (paclitaxel) package insert. Princeton, NJ: Bristol-Meyers Squibb; 2011 Apr.29646 - Moreland LW, Bucy RP, Weinblatt ME, et al. Immune function in patients with rheumatoid arthritis treated with etanercept. Clin Immunol 2002;103:13-21.30470 - Tysabri (natalizumab) package insert. Cambridge, MA: Biogen Idec Inc.; 2020 Jun.31109 - Tamiflu (oseltamivir phosphate) package insert. South San Francisco, CA: Genentech; 2019 Aug.31761 - Orencia (abatacept) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2020 Jun.32057 - Cortef (hydrocortisone tablets, USP) package insert. New York, NY: Pharmacia & Upjohn Co., Inc.; 2019 Nov.33280 - Torisel (temsirolimus injection) package insert. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2011 Jun.33837 - Arcalyst (rilonacept) package insert. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2021 Mar.33930 - Cimzia (certolizumab pegol) subcutaneous injection package insert. Smyrna, GA: UCB Inc.; 2019 Sept.35421 - Relenza (zanamivir) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Jun.35501 - Simponi (golimumab) injection package insert. Horsham, PA: Janssen Biotech, Inc.; 2019 Sept.36889 - Stelara (ustekinumab) package insert. Horsham, PA: Janssen Biotech Inc.; 2020 Dec.38283 - Actemra (tocilizumab) injection package insert. South San Francisco, CA: Genentech, Inc.; 2021 Mar.41361 - Solu-Medrol (methylprednisolone sodium succinate for injection) package insert. New York, NY: Pharmacia and Upjohn Co; 2021 May.41378 - Ilaris (canakinumab) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2020 Sept.41823 - Gilenya (fingolimod) package insert. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 2019 Dec.41849 - Simulect (basiliximab) package insert. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 2020 August41853 - Proleukin (aldesleukin) package insert. San Diego, CA: Prometheus Laboratories Inc.; 2012 Jul.41904 - Evomela (Melphalan hydrochloride) injection package insert. East Windsor, NJ:Acrotech Biopharma LLC; 2019 Aug.43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.43319 - Prednisone tablet package insert. Salisbury, MD: Cadista Pharmaceuticals Inc.; 2016 Mar.43658 - Benlysta (belimumab) injection package insert. Rockville, MD: Human Genome Sciences, Inc.; 2020 Dec.43740 - Omnipred (prednisolone acetate suspension) package insert. Fort Worth, TX: Alcon Laboratories, Inc.; 2007 Oct.44667 - Nulojix (belatacept) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2021 Jul.44928 - Alkeran (melphalan) injection package insert. Weston, FL: ApoPharma USA Inc.; 2018 Nov.45339 - Flo-Pred (prendisolone acetate) package insert. Hawthorne, NY: TaroPharma; 2021 July.46061 - Amantadine HCl oral solution package insert. Amityville, NY: Hi-Tech Pharmacal Co., Inc.; 2015 Jan.48215 - Mitoxantrone injection package insert. Irvine, CA: Teva Parenteral Medicines, Inc.; 2011 Sep.48339 - Cytarabine injection package insert. Bedford, OH: Bedford Laboratories; 2008 Sep.48344 - Fdur (floxuridine) package insert. Paramus, NJ: Mayne Pharma (USA), Inc.; 2007 Nov.49062 - Amevive (alefacept) package insert. Deerfield, IL: Astellas Pharma US, Inc.; 2011 Dec.49489 - Cortisone acetate tablet package insert. Eatontown, N.J.: Hikma Pharmaceuticals USA Inc.; 2016 July49507 - Fludrocortisone acetate package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2020 May.49610 - Actimmune (interferon gamma-1b) injection solution package insert. Lake Forest, IL: Horizon Pharma USA, Inc.; 2017 May.49634 - Arava (leflunomide) package insert. Bridgewater, NJ:. Sanofi-Aventis U.S. LLC; 2016 Feb.49823 - Afinitor (everolimus) tablets package insert. East Hanover, NJ:Novartis Pharmaceuticals Corporation; 2021 April.49903 - Zortress (everolimus) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018 Aug.51027 - Ifex (ifosfamide) package insert. Deerfield, IL: Baxter Healthcare Corp; 2018 Jul51778 - Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 1993;42:1-1851794 - Aubagio (teriflunomide) tablets package insert. Genzyme Corporation: Cambridge, MA; 2021 Apr.52315 - Xeljanz and Xeljanz XR (tofacitinib) package insert. New York, NY: Pfizer, Inc.; 2020 Sept.53824 - Fluorouracil injection package insert. New York, NY: Pfizer Labs; 2012 Aug.54049 - Solu-cortef (hydrocortisone sodium succinate) injection package insert. New York, NY: Pharmacia & Upjohn Co.; 2021 May.54286 - Dexamethasone tablets USP, Dexamethasone oral solution, and Dexamethasone Intensol (oral solution concentrate) package insert. Eatontown, NJ: West-Ward Pharmaceuticals Corp; 2016 March.55836 - Bexxar (tositumomab and iodine I 131 tositumomab) package insert. Wilmington, DE: GlaxoSmithKline LLC; 2013 May.56085 - Vincristine sulfate injection package insert. Sellersville, PA: Teva Pharmaceuticals USA; 2013 Mar.56146 - Kenalog-40 (triamcinolone acetonide) injection package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2019 April.56353 - Gazyva (obinutuzumab) injection package insert. South San Francisco, CA: Genentech, Inc.; 2020 Mar.56871 - Navelbine (vinorelbine) injection package insert. Parsippany, NJ: Pierre Fabre Pharmaceuticals Inc; 2020 Jan.57062 - Sylvant (siltuximab) injection package insert. Hertfordshire, U.K.: EUSA Pharma (UK), Ltd.; 2019 Dec.57235 - Entyvio (vedolizumab) injection. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; 2019 May.58408 - Docetaxel injection package insert. Princeton, NJ: Sandoz, Inc.; 2021 Jan.58461 - Lemtrada (alemtuzumab) injection package insert. Cambridge, MA: Genzyme Corporation; 2021 Apr.58559 - Ziextenzo (pegfilgrastim-bmez) injection package insert. Princeton, NJ: Sandoz Inc.; 2021 Mar.58671 - Rapivab (peramivir injection) package insert. Durham, NC: BioCryst Pharmacetuicals, Inc; 2021 Jan.58739 - Cosentyx (secukinumab) injection package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2021 May.60092 - Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014; 58: e44-100.60497 - Envarsus XR (tacrolimus) extended-release tablets. Cary, NC: Veloxis Pharmaceuticals, Inc.; 2020 Sept.60658 - Taltz (ixekizumab) injection package insert. Indianapolis, IN: Eli Lilly and Company; 2021 Mar.60706 - Venclexa (venetoclax) tabs package insert. South San Francisco, CA: Genentech, Inc.; 2020 Nov.60841 - Zinbryta (daclizumab) injection package insert. Cambridge, MA: Biogen, Inc.; 2017 Aug.61750 - Emflaza (deflazacort) tablets and oral suspension. South Plainfield, NJ: PTC Therapeutics; 2021 Jul.61762 - Siliq (brodalumab) injection. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017 Feb.61836 - Dupixent (Dupilumab) injection package insert. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2021 Jun.61838 - Ocrevus (ocrelizumab) injection package insert. South San Francisco, CA: Genentech, Inc.; 2020 Dec.61976 - Kevzara (sarilumab) package insert. Bridgewater, NJ: Sanofi-Aventis US. LLC; 2018 Apr.62120 - Tremfya (guselkumab) injection package insert. Horsham, PA: Janssen Biotech, Inc.; 2020 Jul.62262 - Gocovri (amantadine extended-release capsules) package insert. Emeryville, CA: Adamas Pharma LLC; 2021 Jan.62273 - Amantadine HCl immediate-release capsules package insert. Parsippany, NJ: Actavis Pharma, Inc.; 2017 Jan.62282 - Kymriah (tisagenlecleucel) suspension for IV infusion package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018 May.62530 - Yescarta (axicabtagene ciloleucel) suspension for injection package insert. Santa Monica, CA: Kite Pharma, Inc.; 2021 Mar.62887 - Osmolex ER (amantadine extended-release tablets) package insert. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; 2018 Feb.62970 - tildrakizumab-asmn (Ilumya) injection package insert. Whitehouse Station, NJ: Merck & Co., Inc.; 2018 Mar.63229 - Olumiant (baricitinib) tablets package insert. Indianapolis, IN: Lilly USA, LLC; 2020 Jul.63436 - Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-2021 Influenza Season. MMWR 2020;69(No. RR-8):1-24.63767 - Gamifant (emapalumab) package insert. Geneva, Switzerland: Novimmune SA; 2018 Nov.64031 - Mayzent (siponimod) tablets package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2021 Jan.64073 - Skyrizi (risankizumab) injection package insert. North Chicago, IL: AbbVie Inc.; 2021 Apr.65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed on July 26, 202165169 - Ozanimod (Zeposia) capsules package insert. Summit, NJ: Celgene Corporation; 2021 May.65576 - Uplizna (inebilizumab-edon) injection package insert. Gaithersburg, MD: Viela Bio, Inc.; 2020 Jun.65739 - Tecartus (brexucabtagene autoleucel) injection package insert. Santa Monica, CA: Kite Pharma, Inc.; 2020 July.65841 - Enspryng (satralizumab-mwge) injection package insert. South San Francisco, CA: Genentech, Inc.; 2021 May.65850 - Kesimpta (ofatumumab) injection package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2020 Aug.66336 - Lupkynis (voclosporin) capsules package insert. Rockville, MD: Aurinia Pharma U.S., Inc.; 2021 Jan.66383 - Breyanzi (lisocabtagene maraleucel) injection package insert. Bothell, WA: Juno Therapeutics, Inc.; 2021 Feb.66527 - Ponvory (ponesimod) tablet package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2021 Mar.

      Monitoring Parameters

      • laboratory monitoring not necessary

      US Drug Names

      • FluMist
      ;