Flumist 2026-2027 (influenza vaccine trivalent live 2026-2027 (2 yrs-49 yrs))

The dosing schedule (i.e., number of doses) of seasonal influenza vaccine live intranasal for prevention of seasonal influenza depends on the individual's age and vaccination history.

A single dose of seasonal influenza vaccine live intranasal consists of the entire contents (0.2 mL) of the sprayer (approximately one-half of the contents or 0.1 mL in each nostril).

Influenza vaccine live intranasal is administered intranasally using the prefilled, single-use sprayer supplied by the manufacturer.

The single-use sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Influenza Virus Vaccine Live/Selected Antiviral Agents

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may inactivate the intranasal live influenza virus vaccine, preventing the body from developing an immune response.

CLINICAL EFFECTS: Administration of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir,(5) may render the intranasal live influenza virus vaccine ineffective.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturers of amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir(4), baloxavir(5), and the intranasal live influenza virus vaccine(6) state that these agents should not be initiated within 2 weeks of the administration of the intranasal live influenza virus vaccine and that the vaccine should not be administered within 48 hours of the discontinuation of these agents. Inactivated influenza vaccine may be used at any time.(1)

DISCUSSION: Because antiviral drugs such as amantadine,(1) oseltamivir,(2) rimantadine,(3) zanamivir,(4) and baloxavir (5) inhibit the replication of live viruses, these agents may interfere with the efficacy of the intranasal live influenza virus vaccine.

Live Vaccines/Bevacizumab

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Systemic bevacizumab suppresses the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency. Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Intravitreal injections of small doses of bevacizumab for macular degeneration or macular edema are not expected to suppress immune function. For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Live Vaccines/Rebisufligene Etisparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1) The vaccine may result in illness.(1,2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)

DISCUSSION: Rebisufligene etisparvovec therapy may pose a risk for vaccine-derived infections and decrease the effectiveness of vaccines.(1)

Live Vaccines/Vusolimogene Oderparepvec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: The interaction potential of live virus vaccines with vusolimogene oderparepvec is unknown.

CLINICAL EFFECTS: Concurrent administration of live vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that vaccines containing live attenuated viruses should be avoided during vusolimogene oderparepvec therapy.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)

DISCUSSION: The concomitant use of live attenuated vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is based on vaccine guidance used in clinical trials.(2)

Live Vaccines; Live Bcg/Selected Immunosuppressive Agents

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Selected Live Viral Vaccines/Rho Immunoglobulin

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Immune globulin products may prevent the immune system from properly responding to the vaccine.(1-6)

CLINICAL EFFECTS: Administration of a live viral vaccine after immunoglobulins may impair the efficacy of the vaccine.(1-6) Administration of immunoglobulins within 2-4 weeks after a live viral vaccine impair the efficacy of the vaccine.(1-6)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Administration of a live viral vaccine should be postponed for three months in patients who have received immunoglobulin therapy, including Rho immunoglobulin.(1-6) If a live viral vaccine is given within two to four weeks of rho immunoglobulin, then repeat vaccination three months after the completion of immunoglobulin should be considered.(2-4)

DISCUSSION: Administration of a live viral vaccine after immunoglobulins(1-6) or administration of immunoglobulins after a live vaccine(3) may impair the efficacy of the vaccine.

Vaccines/Pariglasgene Brecaparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)

DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Influenza Virus Vaccine Live/Salicylates

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Use of salicylates during influenza infection has been associated with Reye's Syndrome.(1,2)

CLINICAL EFFECTS: Use of the live influenza virus vaccine in children and adolescents (patients age 2-17 years) receiving salicylate therapy may increase the risk of Reye's Syndrome.(1,2) Symptoms of Reye's syndrome include drowsiness, confusion, seizures, coma. In severe cases, Reye's syndrome can result in death.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The use of live influenza virus vaccine in children and adolescents (patients age 2-17 years) receiving salicylate therapy is contraindicated.(1,2) Use of salicylates should be avoided for 4 weeks after administration of live influenza vaccine.(1)

DISCUSSION: Because the use of salicylates during influenza infection has been associated with Reye's Syndrome, the use of live influenza virus vaccine in children and adolescents (patients age 2-17 years) receiving salicylate therapy is contraindicated.(1,2)

Live Vaccines/Brensocatib

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1). Brensocatib prevents the activation of neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness. Immune response to live vaccines may be decreased during periods of immunocompromise.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The coadministration of live vaccines and brensocatib should be avoided.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(2)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) The concomitant use of live attenuated vaccines and brensocatib has not been evaluated. Brensocatib may suppress the immune system by inhibiting dipeptidyl peptidase-1 (DPP-1).(1)

Live Vaccines/Leniolisib

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Leniolisib modifies the immune system. Immune response to live vaccines may be decreased during treatment with leniolisib.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The manufacturer of leniolisib states live, attenuated vaccinations may be less effective if administered during leniolisib treatment.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Live Vaccines/Live Vaccines

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The immune response to an injectable or nasally administered live vaccine may be impaired if it is administered within 28 days of another injectable or nasally administered live vaccine.(1)

CLINICAL EFFECTS: Non-simultaneous administration (i.e. given on different days) of an injectable or nasally administered live vaccine to an individual who has received another injectable or nasally administered live vaccine in the previous 28 days may result in the second vaccine being ineffective.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The CDC states that multiple injectable or nasal live vaccines (e.g. MMR and varicella) may be administered on the same day. However, injectable or nasally administered live vaccines not administered on the same day should be administered at least 4 weeks apart whenever possible. If injectable or nasal live vaccines are administered less than 4 weeks apart and not on the same day, the vaccine administered second should be considered invalid and be repeated at least 4 weeks after the last, invalid dose.(1)

DISCUSSION: The immune response to a live vaccine may be impaired if it is administered within 28 days of another live vaccine. In a study, patients who received varicella vaccine less than 28 days after MMR vaccination had an increased risk for varicella vaccine failure (i.e., varicella disease in a vaccinated person) of 2.5-fold compared with those who received varicella vaccine before or more than 28 days after MMR.(1)

Live Vaccines/Methotrexate (LOW STRENGTH INJECTION, ORAL)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: A variety of disease modifying agents such as methotrexate suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) CDC recommendations for zoster vaccine state it may be administered to patients receiving methotrexate if the dose is < or = to 0.4 mg/kg/week for treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease or other conditions.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

Live Vaccines/Systemic Corticosteroids; Corticotropin (ACTH)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system. In severely immunocompromised patients, virus replication after administration of live, attenuated-virus vaccines can be enhanced and/or the immune response to the vaccine may be decreased.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1)

PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)

PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. Live vaccines should be deferred for at least 1 month after discontinuation of high-dose systemic steroids administered for 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 4 weeks after a live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(1) The US manufacturer of corticotropin(2) and triamcinolone(3) and the Australian manufacturer of dexamethasone(4) state that administration of live or live-attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids or corticotropin. The manufacturer of deflazacort states that live or live-attenuated vaccines should be administered at least 4 to 6 weeks prior to initiation of therapy with deflazacort.(5)

DISCUSSION: Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Live Vaccines/Tuberculin Testing

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Measles infection and severe acute and chronic infections may induce an anergic state resulting in a false-negative tuberculin test. The live measles vaccine, as well as other live vaccines (e.g. smallpox, varicella, yellow fever) theoretically may also suppress response to tuberculin testing, though the degree of suppression may be less than that expected from acute infection with wild-type virus.(1-4)

CLINICAL EFFECTS: Tuberculin testing that is performed more than one day but less than 28 days after administration of a live vaccine may result in a false negative tuberculin response. Tuberculin testing may be administered simultaneously with live vaccines.(1-4)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The CDC states that live vaccines (e.g. MMR and varicella) and tuberculin testing may be administered within one day of each other at separate administration sites. If it has been more than one day since tuberculin testing has been administered, the live vaccine can be given at any interval after the tuberculin test. However, if the live vaccine has been administered more than one day previously and tuberculin testing is indicated, tuberculin testing should be deferred for at least 4-6 weeks.(1-4)

DISCUSSION: Suppression of response to tuberculin testing has been observed following measles infection, live measles vaccination, and live smallpox vaccination. The degree of suppression after live virus vaccination is likely to be less than that from an acute infection with wild-type virus. There is no data on suppression of response to tuberculin testing with other live vaccines. In the absence of data, the CDC recommends tuberculin testing within one day that a live vaccine is administered. Otherwise the tuberculin test should be deferred for at least 4-6 weeks.(1-4)

Live Vaccines; Live Bcg/Hydroxyurea

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Hydroxyurea may suppress the immune system.(1) Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies), treatments (e.g. radiation) and cytotoxic drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: Recommendations for administration of live vaccines in patients on hydroxyurea are dependent on the indication. The US manufacturers of hydroxyurea recommend avoiding live vaccine use in patients taking hydroxyurea. Evaluate hematologic status prior to and during treatment with hydroxyurea. Provide supportive care and modify the dose or discontinue hydroxyurea as needed.(1) The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued.(2) The ACIP recommendations state that routine vaccinations patients with secondary immunodeficiency such as sickle cell disease are likely effective. Live viral and bacterial vaccines are contraindicated in patients with generalized malignant neoplasm, immunosuppressive, or radiation therapy, depending on immune status.(4)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(2) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(2) A multicenter, randomized, double-blind, placebo-controlled trial in infants and young children with sickle cell disease (BABY HUG) studied the response to pneumococcal and measles, mumps, and rubella vaccines in patients using hydroxyurea. The authors concluded that hydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with sickle cell disease. Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted. No changes in current immunization schedules are recommended; however, for endemic disease or epidemics, adherence to accelerated immunization schedules for the measles, mumps, and rubella vaccine should be reinforced.(5)

Live Vaccines; Live Bcg/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1,2)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained. The vaccine may result in illness.(1,2) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(3)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live-attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) Vaccination should ideally precede the initiation of teplizumab therapy by 8 weeks. Live vaccines are not recommended within the 8 weeks prior to, during, or for 52 weeks after stopping teplizumab therapy.(2)

DISCUSSION: Vaccinations may be less effective if administered within 8 weeks before, during, and for 52 weeks following teplizumab therapy.(2) Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Vaccines/Hepatitis B Vaccine (FENDRIX)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)

CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)

DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)

*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein.

*History of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any influenza vaccine.

*Children and adolescents 2 through 17 years of age receiving aspirin or aspirin-containing therapy because of the association of Reye's syndrome with aspirin use and wild-type influenza infection.

• Cerebrospinal fluid leak
• History of splenectomy
• HIV infection
• Hyposplenism
• Immunosuppression
• Pregnancy
• Presence of cochlear implant

• Guillain-barre syndrome

• Asthma

Adverse effects reported more frequently in adults 18 through 49 years of age receiving seasonal influenza vaccine live intranasal than in those receiving placebo include runny nose (44%), headache (40%), sore throat (28%), tiredness/weakness (26%), muscle aches (17%), cough (14%), chills (9%), nasal congestion (9%), and sinusitis (4%).

Adverse effects reported more frequently in children 2 through 6 years of age receiving seasonal influenza vaccine live intranasal than in those receiving placebo include runny nose/nasal congestion (58%), decreased appetite (21%), irritability (21%), fever (16%), lethargy (14%), sore throat (11%), headache (9%), muscle aches (6%), and chills (4%). Similar adverse effects were reported in older children and adolescents through 17 years of age; in addition, abdominal pain was reported in 12% and decreased activity reported in 6% of vaccine recipients.

Less Frequent

• Asthma exacerbation

Rare or Very Rare

• Anaphylaxis
• Bell's palsy
• Facial edema
• Guillain-barre syndrome
• Meningitis
• Pericarditis
• Urticaria

More Frequent

• Fever
• Headache disorder
• Lethargy
• Nasal congestion
• Sore throat

Less Frequent

• Acute abdominal pain
• Acute bacterial otitis media
• Chills
• Cough
• Fatigue
• General weakness
• Myalgia
• Sinusitis
• Sneezing

Rare or Very Rare

• Anorexia
• Diarrhea
• Epistaxis
• Nausea
• Skin rash
• Vomiting

No enhanced messaging available.

Safety and efficacy of influenza vaccine live intranasal have been established only in children 2 years of age or older.

The effectiveness of influenza vaccine live intranasal in children 6 through 17 years of age is supported by demonstration of efficacy in younger children 6-71 months of age and effectiveness in adults 18-49 years of age.

Influenza vaccine live intranasal should not be administered to infants younger than 24 months of age. An increased incidence of wheezing and hospitalization has been reported in a clinical trial in infants 6 through 23 months of age+ who received influenza vaccine live intranasal compared with those who received parenteral influenza vaccine inactivated.

The manufacturer states that influenza vaccine live intranasal is not absorbed systemically following intranasal administration and use in pregnant women is not expected to result in fetal exposure. Animal reproduction studies performed with influenza vaccine live intranasal have not revealed evidence of harm to the fetus.

Experts state that influenza vaccine live intranasal should not be used during pregnancy. Women who are pregnant or who might become pregnant during the influenza season should be vaccinated using any licensed, age-appropriate, inactivated influenza vaccine (i.e., influenza virus vaccine inactivated or influenza vaccine recombinant).

The manufacturer states that influenza vaccine live intranasal is not absorbed systemically following intranasal administration and distribution into milk is not expected.

ACIP states that live, attenuated virus vaccines generally do not pose any unusual risks for women who are breast-feeding or their breast-fed infants. Although live, attenuated viruses in vaccines can replicate in the mother, the majority of live vaccine viruses are not distributed into milk.

Influenza vaccine live intranasal is not indicated in adults 50 years of age or older, including geriatric adults.

Influenza vaccine live intranasal is not indicated for use in geriatric individuals 65 years of age or older.