Influenza A (H1N1) Vaccine

Pronunciation: IN-floo-EN-za
Class: Vaccine, viral

Trade Names:
CSL Biotherapies
- Injection, suspension (purified split virus) 15 mcg hemagglutinin (HA) of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose

Trade Names:
Influenza A (H1N1) 2009 Monovalent Vaccine
- Spray, suspension, intranasal 10 fluorescent focus units (FFU) of live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus: A/California/7/2009 (H1N1)v per 0.2 mL dose

Trade Names:
Novartis
- Injection, suspension (purified) 15 mcg HA of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose

Trade Names:
Sanofi Pasteur
- Injection, suspension (purified split virus) 15 mcg HA of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose

Pharmacology

Induces formation of specific antibodies that protect against virus strains from which vaccine is prepared or closely related strains.

Indications and Usage

For active immunization against influenza disease caused by pandemic (H1N1) 2009 virus. The injection is indicated in persons 18 yr of age and older ( CSL Biotherapies ), 4 yr of age and older ( Novartis ), and 6 mo of age and older ( Sanofi Pasteur ). The intranasal spray is indicated in persons 2 to 49 yr of age.

Contraindications

Immediate hypersensitivity to the product or its components; hypersensitivity to eggs, egg products, or chicken proteins; life-threatening reactions after previous administration of any influenza vaccine.

Injection ( CSL Biotherapies )

Known severe hypersensitivity to neomycin or polymyxin.

Intranasal

History of hypersensitivity, especially anaphylactic reactions, to gentamicin, gelatin, or arginine; children and adolescents (2 to 17 yr of age) receiving aspirin therapy or aspirin-containing therapy because of the association of Reye syndrome with aspirin and wild-type influenza infection.

Dosage and Administration

Injection
CSL Biotherapies Adults

IM 0.5 mL administered as 1 dose.

Novartis Adults and Children 10 yr of age and older

IM 0.5 mL once.

Children 4 to 9 yr of age

IM 2 doses of 0.5 mL, administered 1 month apart.

Sanofi Pasteur Adults and Children 10 yr of age and older

IM 0.5 mL once.

Children 3 to 9 yr of age

IM 2 doses of 0.5 mL, administered 1 month apart.

Children 6 to 35 mo of age

IM 2 doses of 0.25 mL, administered 1 month apart.

Intranasal
Adults and Children 10 to 49 yr of age

Nasal inhalation 1 dose (0.2 mL) administered as 0.1 mL/nostril.

Children 2 to 9 yr of age

Nasal inhalation 2 doses (0.2 mL each, approximately 1 month apart), administered as 0.1 mL/nostril.

General Advice

  • Injection
  • For IM administration only. Not for intradermal, subcutaneous, IV, or intra-arterial administration.
  • Do not mix with any other vaccine in the same syringe or vial.
  • Shake the syringe or single-dose vials well before administering; shake the multidose vial each time before withdrawing a dose. Administer vaccine to adults in deltoid muscle using needles 1 inch or longer to ensure penetration of muscle mass.
  • Administer vaccine to children in deltoid muscle with adequate deltoid muscle mass needles ⅞ to 1¼ inches in length to ensure penetration of muscle mass.
  • Administer vaccine to infants older than 6 mo of age and young children in anterolateral aspect of thigh using needles ⅞ to 1 inch in length to ensure penetration of muscle mass.
  • If influenza A (H1N1) 2009 injection vaccine is to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered at different injection sites
  • Intranasal spray
  • For nasal use only. Not for parenteral administration.
  • Administer 50% of dose (a single spray) into each nostril while the patient is in an upright position. Insert tip of sprayer just inside nostril and depress plunger to spray. Remove dose divider clip and administer remaining 50% of dose into the other nostril.
  • Dispose of used sprayer following approved procedures for disposal of biohazardous waste.
  • Active inhalation (eg, sniffing) is not required by the patient during vaccine administration.

Storage/Stability

Injection

Store in refrigerator at 36° to 46°F; do not freeze. Protect from light.

Intranasal

Store in refrigerator at 36° to 46°F; do not freeze.

Drug Interactions

Antivirals

Do not administer intranasal influenza A (H1N1) vaccine until 48 h after cessation of antiviral therapy; do not administer antivirals until 14 days after giving intranasal influenza A (H1N1) vaccine unless medically indicated.

Aspirin

Because of the association of Reye syndrome with aspirin and wild-type influenza infection, intranasal influenza A (H1N1) vaccine is contraindicated in children and adolescents receiving aspirin or aspirin-containing products.

Hydantoins (eg, phenytoin), theophylline, warfarin

Clearance of these agents may be inhibited by influenza vaccine; however, no adverse clinical effects have been reported.

Immunosuppressive agents (eg, corticosteroid)

The response to influenza A (H1N1) vaccine may be diminished.

Vaccines

There are no data to assess concurrent use of other vaccines with influenza A (H1N1) vaccine.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Injection Novartis

Hypertension (5%); syncope, vasculitis (postmarketing).

Sanofi Pasteur

Vasculitis, vasodilation/flushing (postmarketing).

CNS

Injection CSL Biotherapies

Headache (26%); malaise (20%); convulsions, encephalopathy, Guillain-Barré syndrome, neuralgia, neuritis or neuropathy, paresthesia, transverse myelitis (postmarketing).

Novartis

Headache (33%); malaise (19%); fatigue (18%); migraine (6%); confusion, dizziness, febrile convulsions, Guillain-Barré syndrome, myelitis including encephalomyelitis and transverse myelitis, neuralgia, neuropathy, paralysis including Bell palsy, paresthesia (postmarketing).

Sanofi Pasteur

Guillain-Barré syndrome; transient encephalopathy; asthenia/fatigue, brachial neuritis, convulsions, dizziness, encephalomyelitis, facial palsy, malaise, optic neuritis/neuropathy, paresthesia, syncope (postmarketing).

Intranasal

Headache (40%); tiredness/weakness (26%); decreased appetite, irritability (21%); lethargy (14%); Bell palsy, Guillain-Barré syndrome (postmarketing).

Dermatologic

Injection CSL Biotherapies

Pruritus, rash, urticaria (postmarketing).

Novartis

Sweating (9%); pruritus (1%); facial edema, hot flashes/flushes, rash (including nonspecific, maculopapular, and vesiculobulbous), Stevens-Johnson syndrome, urticaria (postmarketing).

Sanofi Pasteur

Pruritus, Stevens-Johnson syndrome (postmarketing).

Intranasal

Rash (postmarketing).

EENT

Injection CSL Biotherapies

Nasal congestion (7%); pharyngolaryngeal pain, rhinorrhea (5%).

Novartis

Pharyngitis (13%); sore throat (8%); rhinitis (7%); rhinorrhea (6%).

Sanofi Pasteur

Pharyngitis, rhinitis (postmarketing).

Intranasal

Nasal congestion/runny nose (58%); sore throat (28%); otitis media (3%); sneezing (2%).

GI

Injection CSL Biotherapies

Nausea (6%); vomiting (1%).

Novartis

Nausea (7%); abdominal pain, diarrhea, vomiting (postmarketing).

Intranasal

Abdominal pain (12%); diarrhea, nausea, vomiting (postmarketing).

Genitourinary

Injection CSL Biotherapies

Vasculitis with transient renal involvement (postmarketing).

Hematologic-Lymphatic

Injection CSL Biotherapies

Transient thrombocytopenia (postmarketing).

Novartis

Ecchymosis (7%); hemorrhage (1%); lymphadenopathy, transient thrombocytopenia (postmarketing).

Sanofi Pasteur

Lymphadenopathy, thrombocytopenia (postmarketing).

Hypersensitivity

Injection CSL Biotherapies

Allergic reactions including anaphylactic shock and serum sickness (postmarketing).

Novartis

Hypersensitivity reactions including anaphylaxis, death, and throat and mouth edema (postmarketing).

Sanofi Pasteur

Immediate allergic reactions including anaphylaxis, angioedema, and asthma.

Intranasal

Hypersensitivity reactions including anaphylactic reaction, facial edema, and urticaria (postmarketing).

Local

Injection CSL Biotherapies

Tenderness (60%); pain (40%); redness (23%); swelling (11%); bruising (5%); induration and inflammation (postmarketing).

Novartis

Pain (55%); erythema (22%); induration, swelling (15%); mass (11%); inflammation (9%); edema (6%); pain limiting limb movement, redness, swelling, warmth (postmarketing).

Sanofi Pasteur

Soreness (10% to 61%).

Metabolic-Nutritional

Injection Novartis

Loss of appetite (postmarketing).

Musculoskeletal

Injection CSL Biotherapies

Muscle aches (14%); back pain (2%).

Novartis

Myalgia (21%); back pain (7%); arthralgia (6%); myasthenia (postmarketing).

Sanofi Pasteur

Myalgia including transverse myelitis, pain in extremities (postmarketing).

Intranasal

Muscle aches (17%).

Respiratory

Injection CSL Biotherapies

Cough (5%); upper respiratory tract infection (2%); lower respiratory tract infection (1%).

Novartis

Cough (6%); difficulty breathing, wheezing (1%); chest pain, dyspnea (postmarketing).

Sanofi Pasteur

Dyspnea (postmarketing).

Intranasal

Cough (14%); sinusitis (4%); epistaxis (postmarketing).

Miscellaneous

Injection CSL Biotherapies

Chills/shivering (7%); fever (1%); influenza-like illness (postmarketing).

Novartis

Chills (7%); fever, infection (5%); chest tightness, shivering (1%).

Sanofi Pasteur

Chest pain, fever, pain. (postmarketing).

Intranasal

Chills (9%); decreased activity (6%); fever; exacerbation of symptoms of mitochondrial encephalomyopathy (postmarketing).

Precautions

Pregnancy

Category C.

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 mo of age ( Sanofi Pasteur ). Safety and efficacy not established in children younger than 4 yr of age ( Novartis ). Safety and efficacy not established in children younger than 2 yr of age (intranasal). CSL Biotherapies injection formulation is not indicated for use in children.

Elderly

Intranasal

Not indicated for persons 50 to 64 yr of age; safety and efficacy not established in persons 65 yr of age and older.

Hypersensitivity

Anaphylactic reactions have been reported.

Asthma

Do not administer intranasal influenza A (H1N1) vaccine to persons with asthma or to children younger than 5 yr of age with recurrent wheezing unless the benefit outweighs the risk.

Bleeding disorders

Because of the risk of hematoma, do not administer parenteral influenza A (H1N1) vaccine to persons with bleeding disorders such as hemophilia or thrombocytopenia, or to persons receiving anticoagulants.

Efficacy

Influenza A (H1N1) vaccination may not protect all persons.

Febrile illness

Defer vaccination in patients with acute febrile illness for at least 72 h or until symptoms have abated.

Guillain-Barré syndrome

Avoid administration to persons known to have experienced Guillain-Barré syndrome within 6 wk after a previous influenza vaccination unless benefit outweighs the risk.

High-risk persons

Intranasal influenza A (H1N1) vaccine is not indicated for persons with underlying medical conditions that could predispose them to severe disease following wild-type influenza infection (eg, patients with chronic disorders of the CV and pulmonary systems, pregnant women, chronic metabolic diseases requiring regular medical follow-up or hospitalization during the proceeding year, renal function impairment, hemoglobinopathies).

Immunocompromised persons

Immune response may be diminished. Because intranasal influenza A (H1N1) vaccine is a live virus vaccine, use with caution in immunocompromised persons.

Patient Information

  • Review benefits and risks of the vaccine and importance of completing the immunization series.
  • Provide patient, parent, or guardian with immunization history record and record this immunization in patient immunization record.
  • Provide and review patient information leaflet prior to immunization.
  • Advise patient, parent, or caregiver that vaccine will be prepared and administered by health care provider.
  • Remind patient, parent, or caregiver that vaccine needs to be administered every year in order to provide ongoing protection.
  • Instruct patient to report any severe or unusual adverse reactions to health care provider.
  • Injection
  • Educate patient, parent, or caregiver that vaccine contains noninfectious killed viruses and cannot cause influenza, but coincidental respiratory disease unrelated to influenza vaccine can occur after vaccination.
  • Advise patient receiving parenteral vaccine that soreness at injection site is the most common adverse reaction and may last for up to 2 days.
  • Advise patient, parent, or caregiver that fever, general body discomfort, and muscle pain can develop, and to use nonnarcotic analgesic and antipyretic (eg, ibuprofen) for symptomatic relief. Advise patient, parent, or caregiver to report severe or persistent symptoms to health care provider.
  • Advise patient, parent, or caregiver to notify health care provider immediately if unusual neurologic reactions (eg, abnormal skin sensations, paralysis, unexplained change in thinking or behavior) are noted.
  • Advise parent or guardian of child younger than 9 yr of age who has not previously received influenza vaccine that a second dose, at least 4 wk after the first dose, is required to obtain max protection.
  • Intranasal spray
  • Caution patient, parent, or caregiver to have vaccine recipient avoid close contact (eg, within same household) with immunocompromised persons for at least 21 days following vaccination.
  • Caution health care worker who receives vaccine to avoid contact with severely immunocompromised patients for 7 days following vaccination.
  • Advise parent or guardian of child 2 to 9 yr of age who has not previously received intranasal influenza A (H1N1) vaccine that a second dose, at least 4 wk after the first dose, is required to obtain max protection.

Copyright © 2009 Wolters Kluwer Health.

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