influenza virus vaccine quadrivalent, recombinant (Rx)

Brand and Other Names:Flublok Quadrivalent
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Dosing & Uses

AdultPediatric

Dosage Forms & 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 2017-2018 northern hemisphere season:

  • A/Michigan/45/2015 (H1N1)pdm09-like virus (new for 2017-2018)
  • A/Hong Kong/4801/2014 (H3N2)-like virus (no change from last season)
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)
  • B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (no change from last season)

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

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and influenza virus vaccine quadrivalent, recombinant

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            Adverse 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%)

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            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

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            Pregnancy & 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.

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            Pharmacology

            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

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            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

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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