Version May 2024
Influenza A (H5N1) prevention: Note: There are no data to support the interchangeability of vaccines.
Seqirus (MF59-adjuvanted: Audenz, Foclivia [Canadian product]) and GlaxoSmithKline (AS03-adjuvanted) products: IM: 0.5 mL followed by a second 0.5 mL dose administered 21 days later.
Sanofi Pasteur product: Adults 18 to 64 years of age: IM: 1 mL followed by second 1 mL dose administered ~28 days later (acceptable range: 21 to 35 days).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Avian influenza virus vaccine (H5N1) (United States: Availability limited to CDC distribution from Strategic National Stockpile in consultation with local health department): Pediatric drug information")
Influenza A subtype H5N1, immunization :
Note: Available vaccines are manufactured differently; dose volumes are different (eg, 0.25 mL vs 0.5 mL per dose); use caution when verifying product selection and dose volume.
GlaxoSmithKline product (AS03-adjuvanted):
Infants ≥6 months, Children, and Adolescents ≤17 years: IM: 0.25 mL, followed by a second 0.25 mL dose 21 days later.
Adolescents ≥18 years: IM: 0.5 mL, followed by a second 0.5 mL dose 21 days later.
Seqirus product (MF59-adjuvanted: Audenz, Foclivia [Canadian product]):
Infants ≥6 months, Children, and Adolescents: IM: 0.5 mL, followed by a second 0.5 mL dose 21 days later.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Actual percentages may vary by product and age group.
>10%:
Dermatologic: Diaphoresis (6% to 11%)
Gastrointestinal: Abdominal pain (children and adolescents: ≤17%), anorexia (children and adolescents: 14% to 29%), change in appetite (infants and children: 18%), diarrhea (≤17%), nausea (≤17%), vomiting (children and adolescents: ≤17%)
Local: Erythema at injection site (≤34%), induration at injection site (≤15%), pain at injection site (36% to 83%), swelling at injection site (adults: ≤15%; infants, children, and adolescents: 28% to 29%), tenderness at injection site (adults: 70%; infants and children: 56%)
Nervous system: Drowsiness (infants and children: 25% to 38%), fatigue (20% to 34%), headache (3% to 35%), irritability (infants and children: ≤51%), malaise (16% to 25%), shivering (adults: 17%; children and adolescents: 4% to 10%)
Neuromuscular & skeletal: Arthralgia (10% to 25%), myalgia (9% to 45%)
Miscellaneous: Fever (3% to 22%), fussiness in an infant or toddler (≤51%)
1% to 10%:
Gastrointestinal: Gastroenteritis (children and adolescents: 1%)
Local: Itching at injection site (adults: 2%), warm sensation at injection site (adults: 1%)
Nervous system: Chills (older adults: 4%), dizziness (adults: 1%)
<1%:
Dermatologic: Skin rash (adults)
Local: Bruising at injection site (adults)
Seqirus products (Audenz, Foclivia [Canadian product]) (MF59-adjuvanted): Severe allergic reactions (eg, anaphylaxis) to any component of the vaccine or after a previous dose of an influenza vaccine. Note: The Foclivia product labeling states that administration to persons with a history of anaphylaxis to a vaccine component may be appropriate during a pandemic situation if acute medical facilities/treatment are available.
GlaxoSmithKline product (AS03-adjuvanted): Severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or after a previous dose of an influenza vaccine.
Sanofi Pasteur product: There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); more often reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).
Disease-related concerns:
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Postpone administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]).
• Guillain-Barré syndrome: Use with caution in patients with a history of Guillain-Barré syndrome (GBS); patients with history of GBS have a greater likelihood of developing GBS than those without. Although data specific to the influenza A virus vaccine (H5N1) are unavailable, the following guidance is based on seasonal influenza vaccines: As a precaution, the Advisory Committee on Immunization Practices (ACIP) recommends that patients with a history of GBS and who are at low risk for severe influenza complications and patients known to have experienced GBS within 6 weeks following previous vaccination should generally not be vaccinated (consider influenza antiviral chemoprophylaxis in these patients). The benefits of vaccination may outweigh the potential risks in persons with a history of GBS who are also at high risk for complications of influenza (CDC/ACIP [Grohskopf 2019]). Studies of patients who received the trivalent inactivated influenza vaccine or the monovalent H1N1 influenza vaccine have shown the risk of GBS is lower with vaccination than with influenza infection (Baxter 2013; Greene 2013; Kwong 2013).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2023]).
Special populations:
• Altered immunocompetence: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adult: Sanofi Pasteur product has not been evaluated in patients ≥65 years of age
• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2023]).
Dosage form specific issues:
• Chicken egg protein: Some products may be manufactured with chicken egg protein.
• Kanamycin: Some products may be manufactured with kanamycin.
• Neomycin: Some products may be manufactured with neomycin.
• Thimerosal: Some products may contain thimerosal; hypersensitivity reactions may occur.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Products will not be commercially available; distribution will be limited as part of the US Strategic National Stockpile.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, emulsion [monovalent]:
GlaxoSmithKline product: Adjuvanted Hemagglutinin [A/Indonesia/05/2005 (H5N1)] 3.75 mcg/0.5 mL (5 mL) [contains egg protein, polysorbate 80, and thimerosal]
Seqirus product: Adjuvanted Hemagglutinin [A/turkey/Turkey/1/2005 NIBRG-23 (H5N1)] 7.5 mcg/0.5 mL (0.5 mL, 5 mL) [contains polysorbate 80; 0.5 mL prefilled syringe contains mercury; 5 mL vial contains thimerosal]
Injection, suspension [monovalent]:
Sanofi Pasteur product: Hemagglutinin [A/Vietnam/1203/2004 (H5N1)] 90 mcg/mL (5 mL) [contains chicken and egg protein, porcine gelatin, and thimerosal]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, emulsion [monovalent]:
GlaxoSmithKline product: Adjuvanted Hemagglutinin [A/Indonesia/5/2005 (H5N1)] 3.75 mcg/0.5 mL (5 mL) [contains egg protein, polysorbate 80, and thimerosal]
Seqirus product: Adjuvanted Hemagglutinin [A/Vietnam/1194/2004 (H5N1)] 7.5 mcg/0.5 mL (0.5 mL, 5 mL) [contains polysorbate 80; 5 mL vial contains thimerosal]
Commercial distribution is not planned. The vaccine will be included as part of the US Strategic National Stockpile. It will be distributed by public health officials if needed.
IM: For IM administration only. Gently shake prior to use. Inspect for particulate matter and discoloration prior to administration. Administer into the deltoid muscle; do not inject into the gluteal region or areas where there may be a major nerve trunk. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (Ref). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
GlaxoSmithKline product (AS03-adjuvanted): If vaccine is stored under refrigeration after mixing, bring to room temperature prior to administration (minimum 15 minutes). Mix thoroughly by inversion prior to administration.
Seqirus product (MF59-adjuvanted: Audenz, Foclivia [Canadian product]): Gently shake prior to administration; appearance should be milky white.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Parenteral: IM: For IM administration only. Inspect for particulate matter and discoloration prior to administration. Administer into the deltoid muscle in children and adolescents; the anterolateral thigh is preferred for infants ≥6 months. Do not inject into areas where there may be a major nerve trunk, including the gluteal region. If injected in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). US law requires that the date of administration; the vaccine manufacturer; lot number of vaccine; and the administering person's name, title, and address be entered into the patient's permanent medical record.
GlaxoSmithKline product (AS03-adjuvanted): If vaccine is stored under refrigeration after mixing, bring to room temperature prior to administration (minimum 15 minutes). Mix thoroughly by inversion prior to administration.
Seqirus product (MF59-adjuvanted: Audenz, Foclivia [Canadian product]): Gently shake syringe prior to administration; appearance should be milky-white.
For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref).
Influenza A (H5N1) prevention:
Seqirus (Audenz, Foclivia [Canadian product]) and GlaxoSmithKline products (adjuvanted): Active immunization of persons ≥6 months of age at increased risk of exposure to the influenza A (H5N1) virus subtype contained in the vaccine.
Note: Audenz: Use in persons 6 months through 17 years of age received accelerated approval based on the immune response elicited by Audenz. Effectiveness of the seasonal vaccine made by the same process has not been confirmed for this age group. Continued approval for use in this age group may be contingent upon verification and description of clinical benefit in confirmatory trials.
Sanofi Pasteur product: Active immunization of persons 18 to 64 years of age at increased risk of exposure to the influenza A (H5N1) virus subtype contained in the vaccine.
Influenza A virus vaccine (H5N1) may be confused with the nonavian or avian strains of influenza virus vaccine
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating methotrexate if possible. If vaccination occurs less than 2 weeks prior to or during methotrexate therapy, revaccinate 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Influenza Virus Vaccines. Management: Influenza virus vaccines are not recommended in the 2 weeks prior to teplizumab treatment, during treatment, or for 6 weeks after treatment. Reduced efficacy of the vaccine may occur if administer to patients taking teplizumab. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Adverse events were not observed in animal reproduction studies using the H5N1 vaccine GlaxoSmithKline adjuvanted product; animal reproduction studies have not been conducted with the Sanofi Pasteur product. Nonlive viral vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]).
It is not known if the components of this vaccine are present in breast milk. Nonlive vaccines have not been shown to affect the safety of the breastfed infant or mother (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Promotes active immunity to influenza A H5N1 (avian).
Onset of action: Most persons have antibody protection within 3 weeks (Audenz, GlaxoSmithKline vaccine, and Foclivia [Canadian product]) or 4 weeks (Sanofi Pasteur vaccine) after complete vaccination.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
