A-Z Drug Facts > Influenza Virus Vaccine

Influenza Virus Vaccine

Pronouncation: (IN-floo-EN-za)
Class: Vaccine, viral

Trade Names:
Afluria
- Injection (purified split virus) hemagglutinin (HA) 15 mcg each of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.5 mL

Trade Names:
Fluarix
- Prefilled syringes for injection (purified split virus) HA 15 mcg each of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.5 mL

Trade Names:
FluLaval
- Injection (purified split-virus) HA 15 mcg each of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.5 mL

Trade Names:
FluMist
- Intranasal spray fluorescent focus units 10 ^6.5-7.5 of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.2 mL

Trade Names:
Fluvirin
- Injection (purified split-virus) HA 15 mcg each of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.5 mL

Trade Names:
Fluzone
- Injection (purified split-virus) HA 15 mcg each of A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 per 0.5 mL

Fluviral S/F (Canada)
Vaxigrip (Canada)

Pharmacology

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

Indications and Usage

Induction of active immunity against the specific influenza viruses corresponding to strains in current-year vaccine formula. Fluvirin is not indicated for children younger than 4 yr of age. FluMist is not indicated in persons younger than 2 yr of age or older than 50 yr of age. Fluzone is not indicated in children younger than 6 mo of age. Afluria , Fluarix , and FluLaval are not indicated in persons younger than 18 yr of age.

Contraindications

Immediate hypersensitivity to product or other components; hypersensitivity to eggs, egg products, or chicken proteins; delayed immunization is recommended for persons with active neurologic disorder characterized by changing neurologic findings; defer immunization during acute respiratory disease or other active infection or during acute febrile illness; known or suspected immune deficiency diseases; life-threatening reaction to previous influenza vaccination.

Afluria

Hypersensitivity to neomycin or polymyxins.

FluMist

Do not administer to persons with a history of hypersensitivity to gentamicin, gelatin, or arginine; do not administer to children and adolescents 2 to 17 yr of age receiving aspirin; do not administer to persons with severe asthma or active wheezing.

Fluvirin

Hypersensitivity to thimerosal. Occurrence of any neurological signs or symptoms following use of Fluvirin is a contraindication to further use.

Dosage and Administration

Afluria , Fluarix , and FluLaval
Adults

IM 0.5 mL administered as 1 dose.

Fluvirin
Adults and Children 9 yr of age and older

IM 0.5 mL administered as 1 dose.

Children 4 to 8 yr of age

IM 0.5 mL administered as 1 dose; however, if previously unvaccinated, give 2 doses at least 1 mo apart, administering the second dose before December if possible.

FluMist (nasal inhalational only)
Adults and Children 9 to 49 yr of age

Nasal 0.2 mL/season.

Children 2 to 8 yr of age

Nasal 0.2 mL/season if previously vaccinated with FluMist ; 2 doses of 0.2 mL/season at least 60 days apart if not previously vaccinated with FluMist .

Fluzone
Adults and Children 9 yr of age and older

IM 0.5 mL administered as 1 dose.

Children 3 to 8 yr of age

IM 0.5 mL administered as 1 dose; however, if previously unvaccinated, give 2 doses at least 1 mo apart, administering the second dose before December, if possible.

Children 6 to 35 mo of age

IM 0.25 mL administered as 1 dose; however, if previously unvaccinated, give as 2 doses at least 1 mo apart, administering the second dose before December if possible.

General Advice

• Do not use vaccine prepared for a previous season to provide protection for current season.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration and name and title of person administering vaccine.

• Parenteral
• For IM administration only. Not for intradermal, subcutaneous, IV, or intra-arterial administration.
• May be coadministered with childhood vaccines.
• May be coadministered with pneumococcal vaccine, using separate syringes and at different sites.
• Do not administer Fluvirin using needleless injectors.
• There are insufficient data to assess coadministration of Fluarix with other vaccines.
• Do not mix Fluarix with any other vaccine in the same syringe or vial.
• Shake multidose vial well before withdrawing dose.
• Shake prefilled syringe well before administering dose.
• Do not administer if solution is discolored or if particulate matter is noted.
• 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 7/ 8 to 1¼ inch 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 7/ 8 to 1 inch in length to ensure penetration of muscle mass.

• Intranasal spray
• For nasal use only. Not for parenteral administration.
• Avoid coadministration of other vaccines.
• 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.

Storage/Stability

Afluria , Fluarix , and FluLaval

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

Fluvirin

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

FluMist and Fluzone

Store in refrigerator at 35° to 46°F; do not freeze.

Drug Interactions

Antivirals

Do not administer FluMist until 48 h after cessation of antiviral therapy; do not administer antivirals until 14 days after giving FluMist unless medically indicated.

Aspirin

Contraindicated in children or adolescents receiving FluMist .

Immunosuppressant drugs (eg, high-dose corticosteroids), radiation therapy

May result in inadequate response to immunization.

Other vaccines

Do not mix with any other vaccine in the same syringe or vial.

Phenytoin, theophylline, warfarin

Use with caution in patients receiving flu vaccine because studies have yielded inconsistent results.

Laboratory Test Interactions

Nasopharyngeal secretions or swabs collected from persons receiving FluMist may test positive for influenza virus for up to 3 wk.

Adverse Reactions

Cardiovascular

Fluarix

Henoch-Schönlein purpura, tachycardia, vasculitis (postmarketing).

FluLaval

Flushing, pallor (postmarketing).

CNS

Afluria

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

Fluarix

Fatigue (20%); asthenia, convulsions, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia (postmarketing).

FluLaval

Headache (18%); fatigue (17%); malaise (11%); pharyngolaryngeal pain (2%); abnormal gait, asthenia, convulsions/seizures, dizziness, encephalopathy, facial or cranial paralysis, Guillain-Barré syndrome, hypoesthesia, hypokinesia, insomnia, limb paralysis, paresthesia, somnolence, syncope, tremor (postmarketing).

FluMist

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

Fluvirin

Guillain-Barré syndrome, insomnia, irritability (25%); malaise.

Fluzone

Guillain-Barré syndrome; transient encephalopathy.

Dermatologic

Afluria

Pruritus, rash, urticaria (postmarketing).

Fluarix

Angioneurotic edema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, urticaria (postmarketing).

FluLaval

Localized or generalized rash, periorbital edema, pruritus, sweating, urticaria (postmarketing).

FluMist

Rash (postmarketing).

Fluvirin

Rash.

EENT

Afluria

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

Fluarix

Nasopharyngitis (3%); nasal congestion (2%); conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling, pharyngitis, rhinitis, tonsillitis, vertigo (postmarketing).

FluLaval

Sore throat (10%); reddened eyes (6%); nasal congestion, nasopharyngitis (1%); conjunctivitis, eye pain, laryngitis, pharyngitis, photophobia, rhinitis, throat tightness (postmarketing).

FluMist

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

GI

Fluarix

Diarrhea (2%); vomiting (1%); abdominal pain or discomfort, nausea, swelling of the mouth, tongue, and/or throat (postmarketing).

FluMist

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

FluLaval

Diarrhea, nausea (1%); dysphagia, vomiting (postmarketing).

Fluzone

Transient optic neuritis/neuropathy.

Genitourinary

Afluria

Vasculitis with transient renal involvement (postmarketing).

Fluarix

Dysmenorrhea (1%).

Hematologic-Lymphatic

Afluria

Transient thrombocytopenia (postmarketing).

Fluarix

Autoimmune hemolytic anemia, lymphadenopathy, thrombocytopenia (postmarketing).

FluLaval

Lymphadenopathy (postmarketing).

Hypersensitivity

Afluria

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

Fluarix

Anaphylactic reaction, including shock, anaphylactoid reaction, hypersensitivity, and serum sickness (postmarketing).

FluLaval

Allergic edema of the face, mouth, and throat; anaphylaxis (postmarketing).

FluMist

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

Fluvirin

Allergic reactions, including anaphylaxis, angioedema, asthma, and hives.

Fluzone

Immediate allergic reactions, including anaphylaxis, angioedema, and asthma.

Local

Afluria

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

Fluarix

Pain (55%); redness (18%); swelling (17%); injection-site abscess, injection-site cellulitis, injection-site mass, injection-site reaction, injection-site warmth, pain (postmarketing).

FluLaval

Pain (24%); redness (11%); swelling (10%); injection-site erythema (1%); injection-site bruising, injection-site inflammation, injection-site rash, injection-site sterile abscess (postmarketing).

Fluvirin and Fluzone

Soreness (10% to 64%).

Musculoskeletal

Afluria

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

Fluarix

Muscle aches (23%); arthralgia 11%); pain in extremities (postmarketing).

FluLaval

Myalgia (13%); arthralgia, back pain (1%); arthritis, bronchospasm, dysphonia, dyspnea, muscle weakness, rigors (postmarketing).

FluMist

Muscle aches (17%).

Fluvirin

Body aches (25%); myalgia.

Respiratory

Afluria

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

Fluarix

Asthma, bronchospasm, cough, dyspnea, pneumonia, respiratory distress, stridor (postmarketing).

FluLaval

Cough (6%); upper respiratory tract infection (1%).

FluMist

Cough (14%); sinusitis (4%); epistaxis, mediastinal and thoracic disorders (postmarketing).

Miscellaneous

Afluria

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

Fluarix

Shivering (7%); fever, influenza-like illness (2%); chest pain, chills, feeling hot (postmarketing).

FluLaval

Fever (11%); chills (5%); chest tightness (3%); facial swelling (1%); cellulitis, chest pain, influenza-like symptoms (postmarketing).

FluMist

Chills (9%); decreased activity (6%); fever.

Fluvirin

Fever (27%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 6 mo of age ( Fluzone ). Safety and efficacy not established in children younger than 4 yr of age ( Fluvirin ). Safety and efficacy not established in children younger than 2 yr of age ( FluMist ). Afluria , Fluarix , and FluLaval are not indicated for use in children.

Elderly

FluMist

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

Hypersensitivity

Anaphylactic reactions have been reported.

Asthma

FluMist

Do not administer to persons with asthma and 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 virus vaccine to persons with bleeding disorders such as hemophilia or thrombocytopenia, or to persons receiving anticoagulants.

Efficacy

Influenza vaccination may not protect all persons.

Febrile convulsions

Fluzone

Since the risk of febrile convulsions is greater in children 6 to 35 months of age, do not administer unless benefit outweighs the risk.

Febrile illness

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

Guillain-Barré syndrome

Afluria , Fluarix , FluLaval , and FluMist

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

Fluzone

Do not administer to persons with a history of Guillain-Barré syndrome.

High-risk persons

Intranasal influenza 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.

FluMist

Because product is a live virus vaccine, use with caution in immunocompromised persons.

Impaired immune response

Patients with impaired immune responsiveness, whether caused by genetic defect, immunodeficiency disease, or immunosuppressive therapy, may have a reduced antibody response to inactivated influenza vaccine and may remain susceptible despite immunization.

Latex sensitivity

Tip cap and rubber plunger of Fluarix needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive persons.

Thrombocytopenia/Coagulation disorder

Do not give injectable influenza virus vaccine to persons with thrombocytopenia or any coagulation disorder that would contraindicate IM injections unless benefit clearly outweighs the risk.

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.

• Parenteral
• 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 5 to 8 yr of age who has not previously received intranasal flu vaccine that a second dose, at least 6 wk after the first dose, is required to obtain max protection.

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