influenza virus vaccine quadrivalent (Fluarix Quadrivalent, Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, FluLaval Quadrivalent, Flucelvax Quadrivalent, Afluria Quadrivalent)

Dosing and uses of Fluarix Quadrivalent, Fluzone Quadrivalent (influenza virus vaccine quadrivalent)

• Adult
• Pediatric

 

Adult dosage forms and strengths

IM suspension

• 0.5mL/syringe
• 0.5mL/vial
• Note: Flucelvax uses mammalian culture instead of chicken embyros

intradermal suspension

• 0.1mL/microinjection system

 

Influenza Prophylaxis

CDC's ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination

0.5 mL IM x1 dose/season

For more vaccine information see https://www.cdc.gov/vaccines/

IntradermaL

• 18-64 yr: 0.1 mL ID x1 dose at beginning of flu season

 

Dosing Considerations

Contains the following 4 viral strains for 2016-2017 northern hemisphere season

A/California/7/2009 (H1N1) pdm09-like virus (same strain as was used for 2009 H1N1 monovalent vaccines)

A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)

B/Phuket/3073/2013-like virus (B/Yamagata lineage)

B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus)

 

Pediatric dosage forms and strengths

IM suspension

• 0.25mL/syringe (Fluzone Quadrivalent)
• 0.5mL/syringe
• 0.5mL/vial
• Note: Flucelvax uses mammalian culture instead of chicken embyros

 

Influenza Prophylaxis

CDC's ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination; https://www.cdc.gov/vaccines/

See Administration section for information regarding if 1 or 2 doses are required for children up to age 8 years

6 months through 35 months (Fluzone Quadrivalent): 0.25 mL IM x 1-2 doses/season

3-8 years: 0.5 mL IM (deltoid) x1-2 doses/season

≥9 years: 0.5 mL IM x1 dose/season

Safety and efficacy not established

• <6 months: Fluzone Quadrivalent
• <3 years: Fluarix Quadrivalent, FluLaval Quadrivalent
• <4 years: Flucelvax Quadrivalent
• <18 years: Afluria Quadrivalent

 

Dosing Considerations

Contains the following 4 viral strains for 2016-2017 northern hemisphere season

A/California/7/2009 (H1N1) pdm09-like virus (same strain as was used for 2009 H1N1 monovalent vaccines)

A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)

B/Phuket/3073/2013-like virus (B/Yamagata lineage)

B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus)

 

Fluarix Quadrivalent, Fluzone Quadrivalent (influenza virus vaccine quadrivalent) adverse (side) effects

>10%

Injection site pain (36%)

Muscle aches (16%)

Headache (16%)

Fatigue (16%)

Children 3-17 years

• Injection site pain (44%)
• Injection site redness (23%)
• Injection site swelling (19%)

Children 3-5 years

• Drowsiness (17%)
• Irritability (17%)
• Loss of appetite (16%)

Children 6-17 years

• Fatigue (20%)
• Muscle aches (18%)
• Headache (16%)

 

1-10%

Arthralgia (8%)

Gastrointestinal symptoms (7%)

Shivering (4%)

Fever 99.5°F (37.5°C) or greater (2%)

Injection site redness or swelling (2%)

Children 3-5 years

• Fever 99.5°F (37.5°C) or greater (9%)

Children 6-17 years

• Arthralgia (10%)
• Gastrointestinal symptoms (10%)
• Shivering (6%)
• Fever 99.5°F (37.5°C) or greater (6%)

 

Postmarketing Reports

Blood and lymphatic disorders: Lymphadenopathy

Cardiac disorders: Tachycardia

Ear and labyrinth disorders: Vertigo

Eye disorders: Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling

Gastrointestinal disorders: Abdominal pain or discomfort, swelling of the mouth, throat, and/or tongue

General disorders and administration site conditions: Asthenia, chest pain, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches

Immune system disorders: Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness

Infections and infestations: Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis

Nervous system disorders: Convulsion, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope

Respiratory, thoracic, and mediastinal disorders: Asthma, bronchospasm, dyspnea, respiratory distress, stridor

Skin and subcutaneous tissue disorders: Angioedema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria

Vascular disorders: Henoch-Schönlein purpura, vasculitis

 

Warnings

Contraindications

Severe hypersensitivity (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine

Persons with hives-only allergy to eggs, can receive the inactivated influenza vaccine

 

Cautions

Use split or purified surface antigen in children

Defer vaccine with febrile illnesses until illness is resolved; may administer vaccine with minor illnesses without fever (eg, URIs)

Expected immune response may not be obtained in immunocompromised individuals, including those receiving immunosuppressive therapy

Influenza vaccine may not protect all susceptible individuals Guillain-Barre syndrome has been reported within 6 weeks of receipt of influenza vaccines

Tip of syringe may contain natural rubber latex

Syncope reported with injectable vaccines

IM injections may cause hematoma in individuals with bleeding disorders (eg, hemophilia, anticoagulant therapy)

 

Pregnancy and lactation

Pregnancy category: B

CDC recommends Influenza vaccine be administered during pregnancy (all trimesters); vaccination during pregnancy shown to decrease risk of illness in the mother, as well as the risk of influenza and influenza hospitalization in their infants during the first 6 months of life (MMWR August 26, 2011;60[33]:1128-32)

Lactation: Unknown whether distributed in breast milk

 

Pregnancy 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.

 

Pharmacology of Fluarix Quadrivalent, Fluzone Quadrivalent (influenza virus vaccine quadrivalent)

Mechanism of action

Inactivated influenza virus types A & B subunits

Conveys active immunity via stimulation of production of endogenously produced antibodies

 

Pharmacokinetics

Onset: Within days to several weeks

Duration: few months

Effectiveness: 70-90%; lower elderly or immunosuppressed individuals

 

Administration

Instructions

Administer at beginning of influenza season

Should not be mixed with any other vaccine in the same syringe or viaL

Shake well before administration

Adults and children >8 years

• IM: Administer IM in deltoid muscle of upper arm
• ID (18-64 yr): Administer ID in deltoid region of upper arm

Children aged 6 months through 8 years

• IM (aged 6-35 months): Administer IM in anterolateral thigh; do not inject in the gluteal area or areas where there may be a major nerve trunk
• IM (aged 3-8 years): Administer IM in deltoid muscle of upper arm
• If child requires 2 doses, administer at least 4 weeks apart (see dosing algorithm)
• Dosing algorithm for children aged 6 months through 8 years
  • Did the child receive at least 1 dose of the previous year’s seasonal influenza vaccine?
  • If yes, give 1 dose
  • If no or don’t know, did the child receive a total of at least 2 doses of seasonal influenza vaccine since July 1, 2010?
  • If yes, give 1 dose and if no or don’t know, give 2 doses
  • From ACIP recommendations: MMWR 2014 Aug 15 / 63(32);691-697

 

Storage

Store refrigerated between 2-8ºC (36-46ºF)

Do not freeze and protect from light