Influenza A (H1N1) VaccinePronunciation: IN-floo-EN-za
Class: Vaccine, viral
- Injection, suspension (purified split virus) 15 mcg hemagglutinin (HA) of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose
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
- Injection, suspension (purified) 15 mcg HA of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose
- Injection, suspension (purified split virus) 15 mcg HA of influenza A/California/7/2009 (H1N1)v-like virus per 0.5 mL dose
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.
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 AdministrationInjection
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.
- 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.
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.
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.
Hypertension (5%); syncope, vasculitis (postmarketing).Sanofi Pasteur
Vasculitis, vasodilation/flushing (postmarketing).
CNSInjection 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).
DermatologicInjection 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
EENTInjection 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%).
GIInjection CSL Biotherapies
Nausea (6%); vomiting (1%).Novartis
Nausea (7%); abdominal pain, diarrhea, vomiting (postmarketing).Intranasal
Abdominal pain (12%); diarrhea, nausea, vomiting (postmarketing).
GenitourinaryInjection CSL Biotherapies
Vasculitis with transient renal involvement (postmarketing).
Hematologic-LymphaticInjection CSL Biotherapies
Transient thrombocytopenia (postmarketing).Novartis
Ecchymosis (7%); hemorrhage (1%); lymphadenopathy, transient thrombocytopenia (postmarketing).Sanofi Pasteur
Lymphadenopathy, thrombocytopenia (postmarketing).
HypersensitivityInjection 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).
LocalInjection 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%).
Loss of appetite (postmarketing).
MusculoskeletalInjection 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%).
RespiratoryInjection 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
Cough (14%); sinusitis (4%); epistaxis (postmarketing).
MiscellaneousInjection 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).
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.
Not indicated for persons 50 to 64 yr of age; safety and efficacy not established in persons 65 yr of age and older.
Anaphylactic reactions have been reported.
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.
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.
Influenza A (H1N1) vaccination may not protect all persons.
Defer vaccination in patients with acute febrile illness for at least 72 h or until symptoms have abated.
Avoid administration to persons known to have experienced Guillain-Barré syndrome within 6 wk after a previous influenza vaccination unless benefit outweighs the risk.
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).
Immune response may be diminished. Because intranasal influenza A (H1N1) vaccine is a live virus vaccine, use with caution in immunocompromised persons.
- 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.
- 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.