Closely (1)prednisone decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.rituximabMonitor Closely (1)rituximab, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.rituximab-hyaluronidaseMonitor Closely (1)rituximab-hyaluronidase, influenza A (H5N1) vaccine. immunosuppressive effects; risk of infection. Use Caution/Monitor. When used for rheumatoid arthritis, follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of rituximab.satralizumabMonitor Closely (1)satralizumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .secukinumabSerious - Use Alternative (1)secukinumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.siponimodSerious - Use Alternative (1)siponimod decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.streptozocinMonitor Closely (1)streptozocin decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.temozolomideMonitor Closely (1)temozolomide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.teplizumabSerious - Use Alternative (1)teplizumab decreases effects of influenza A (H5N1) vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.thioguanineMonitor Closely (1)thioguanine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.thiotepaMonitor Closely (1)thiotepa decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.tralokinumabMonitor Closely (1)tralokinumab will decrease the level or effect of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.triamcinolone acetonide injectable suspensionMonitor Closely (1)triamcinolone acetonide injectable suspension decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Corticosteroids used in greater than physiologic doses may reduce immune response to H5N1 vaccine.ublituximabMonitor Closely (1)ublituximab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.vinblastineMonitor Closely (1)vinblastine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.vincristineMonitor Closely (1)vincristine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.vincristine liposomalMonitor Closely (1)vincristine liposomal decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.vinorelbineMonitor Closely (1)vinorelbine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.voclosporinMonitor Closely (1)voclosporin decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. >10% (Audenz) Adults aged 18-64 yr Injection site pain (64%) Fatigue (25%) Headache (25%) Malaise (22%) Myalgia (14%) Adults aged 65 yr or older Injection site pain (36%) Fatigue (20%) Malaise (16%) Headache (16%) Children aged 6-17 yr Injection site pain (68%) Myalgia (30%) Fatigue (27%) Malaise (25%) Headache (22%) Loss of appetite (14%) Nausea (13%) Arthralgia (13%) Infants and children aged 6 mo through 5 yr Injection site tenderness (56%) Irritability (30%) Sleepiness (25%) Change in eating habits (18%) Fever ≥100.4ºF (16%) 1-10% (Audenz) Adults aged 18-64 yr Arthralgia (10%) Nausea (10%) Adults aged 65 yr or older Arthralgia (10%) Children aged 6-17 yr Fever ≥100.4ºF (4%) Injection site induration (2%) Injection site pain, severe (1%) Injection site erythema (1%) Fatigue, severe (1%) Malaise, severe (1%) Loss of appetite, severe (1%) Nausea, severe (1%) Fever ≥102.1ºF (1%) Infants and children aged 6 mo through 5 yr Injection site erythema (3%) Fever ≥102.1ºF (2%) Injection site tenderness (1%) Injection site induration (1%) Severe irritability (1%) Postmarketing Reports (Audenz) Blood and lymphatic system disorders: Lymphadenopathy Immune system disorders: Hypersensitivity reactions including angioedema and anaphylaxis Nervous system disorders: Bell Palsy, convulsions, including febrile convulsion, demyelination, encephalitis, Guillain-Barre Syndrome, neuritis, paresthesia, syncope Skin and subcutaneous tissue disorders: Urticaria, pruritus, nonspecific rash Musculoskeletal and connective tissue disorders: Muscular weakness Contraindications History of a severe allergic reaction (eg, anaphylaxis) to any vaccine component or after previous dose of an influenza vaccine Cautions Hypersensitivity reactions reported; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions after vaccine administration If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give influenza A (H5N1) vaccine should be based on careful consideration of potential benefits and risks Vaccination may not protect all recipients; immunocompromised individuals may have a diminished immune response Drug interaction overview No data are available to evaluate concomitant administration with other vaccines Immunosuppressive or corticosteroid therapies may reduce immune response to vaccine Pregnancy Data are insufficient to inform of vaccine-associated risks during pregnancy Animal data Female rabbits were administered MF59 adjuvant vaccine 1 and 3 weeks before mating, and on gestation days 7 and 20 No vaccine-related fetal malformations or variations and no adverse effects on preweaning development were observed Clinical considerations Limited information on risk of influenza A (H5N1) infection in pregnant women However, pregnant women infected with pandemic H1N1 or with seasonal influenza are at increased risk of severe illness associated with influenza infection compared to non-pregnant women Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery Lactation Unknown if excreted in human milk; data are not available to assess effects on breastfed infants or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Influenza vaccines induce antibodies against the viral HA in the vaccine, which then blocks viral attachment to human respiratory cells IM Preparation AS03 adjuvant vaccine Supplied as 2 separate vials that must be combined before administration: a vial of H5N1 antigen and a vial of AS03 adjuvant Place 1 vial of H5N1 antigen and 1 vial of AS03 adjuvant at room temperature for minimum of 15 minutes Mix each vial by inversion and inspect visually for particulate matter and discoloration Cleanse both vial stoppers and withdraw the entire contents of the AS03 adjuvant vial using a sterile syringe with a 23-gauge sterile needle and add it to the H5N1 antigen vial to formulate the vaccine (may substitute 22-gauge or 21-gauge needle if 23-gauge needle not available) Mix vaccine thoroughly by inversion; after mixing, label the H5N1 antigen vial (now containing the vaccine) with the date and time mixed in the designated area on the vial label Withdraw 0.5 mL for an adult dose or 0.25 mL for a pediatric dose If stored in refrigerator after mixing, place vaccine at room temperature for minimum of 15 minutes before administration Mix the vaccine thoroughly by inversion before each administration Prefilled syringe (Audenz) Gently shake syringe emulsion IM Administration Aged ≥12 months: Administer preferably in lateral aspect of deltoid muscle of upper arm Aged 6-11 months: Administer in the anterolateral thigh; do not inject gluteal region or areas where a major nerve trunk might be present Storage Unopened AS03 adjuvant vials and MF59 adjuvant (Audenz) prefilled syringes Refrigerate at 2-8ºC (35-46ºF) Do not freeze (discard if frozen) Protect from light AS03 adjuvant storage after mixing Administered within 24 hr of combining Once combined, may refrigerate at 2-8ºC (36-46ºF) or at room temperature up to 30ºC (86ºF) for up to 24 hr Do not freeze (discard if frozen) Protect from light No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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