influenza virus vaccine quadrivalent, recombinant (Flublok Quadrivalent): Dosing and Uses

Dosing and uses of Flublok Quadrivalent (influenza virus vaccine quadrivalent, recombinant)

• Adult
• Pediatric

Adult dosage forms and strengths

IM solution

• 0.5mL/prefilled syringe

Influenza Prophylaxis

Indicated for active immunization against influenza virus subtypes A and B contained in the vaccine for adults aged ≥18 yr

Available for 2017-2018 flu season

0.5 mL IM x1/season

Dosing Considerations

Contents 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) (new for the trivalent vaccine for 2016-2017)

Egg allergy

• The Advisory Committee on Immunization Practices (ACIP) recommends Flublok for vaccination of persons with egg allergy of any severity
• Flublok does not use the influenza virus or chicken eggs in its manufacturing process

Pediatric dosage forms and strengths

<18 years: Safety and efficacy not established

Flublok Quadrivalent (influenza virus vaccine quadrivalent, recombinant) adverse (side) effects

>10%

Injection site tenderness (34-48%)

Injection site pain (19-37%)

Headache (13-20%)

Fatigue (12-17%)

Myalgia (13%)

1-10%

Arthralgia (10%)

Nausea (9%) Chills (7%)

Injection site swelling/bruising (5%)

Injection site redness (4%)

Warnings

Contraindications

Severe hypersensitivity (eg, anaphylaxis) to any component of the vaccine

Cautions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine

Influenza vaccine may not protect all susceptible individuals

If the rare occurrence of Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give the vaccine should be based on careful consideration of the potential benefits and risks

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

Pregnancy and lactation

Pregnancy

Available data on the trivalent or quadrivalent formulations administered to pregnant women are insufficient to inform vaccine-associated risks in pregnant women

Pregnancy outcomes in women who have been exposed to Flublok Quadrivalent during pregnancy are being monitored

Contact: Protein Sciences Corporation 1-888-855-7871

Clinical considerations

• Pregnant women are at increased risk of complications associated with influenza infection compared with nonpregnant women
• Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

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 Flublok Quadrivalent (influenza virus vaccine quadrivalent, recombinant)

Mechanism of action

Contains recombinant hemagglutinin (HA) proteins of the 4 strains of influenza virus specified by health authorities for inclusion in the annual seasonal vaccine

These proteins function as antigens, which induce a humoral immune response, measured by hemagglutination inhibition (HI) antibody

Administration

IM Preparation

Invert the prefilled syringe gently prior to affixing the appropriate size needle for IM administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit

If either of these conditions exists, the vaccine should not be administered

Do not mix in the same syringe with any other vaccine

IM Administration

Preferred IM injection site is the deltoid muscle

Storage

Refrigerate between 2-8°C (36-46°F)

Do not freeze; discard if product has been frozen

Protect syringes from light

Do not use after expiration date