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

0.5 mL IM x1/season

Dosing Considerations

Contents for 2021-2022 Northern Hemisphere season:

  • A/Wisconsin/588/2019 (H1N1)pdm09-like virus (new for 2021-2022)
  • A/Cambodia/30826360/2020 (H3N2)-like virus (new for 2021-2022)
  • B/Washington/02/2019 (B/Victoria lineage)-like virus (no change from last season)
  • B/Phuket/3073/2013-like virus (B/Yamagata lineage) (no change from last season)

Egg allergy

  • The Advisory Committee on Immunization Practices (ACIP) recommends Flublok Quadrivalent for vaccination of persons with egg allergy of any severity
  • Flublok Quadrivalent 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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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • ustekinumab

              ustekinumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            Serious - Use Alternative (5)

            • brodalumab

              brodalumab, influenza virus vaccine quadrivalent, recombinant. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

              brodalumab, influenza virus vaccine quadrivalent, recombinant. Other (see comment). Avoid or Use Alternate Drug. Comment: Prior to initiating brodalumab, complete all age appropriate immunizations. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab.

            • ixekizumab

              ixekizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.

            • ofatumumab SC

              ofatumumab SC decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 2 weeks before initiating ofatumumab SC for inactivated vaccines, and whenever possible.

            • secukinumab

              secukinumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

            • siponimod

              siponimod decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            Monitor Closely (49)

            • adalimumab

              adalimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • alefacept

              alefacept decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • anakinra

              anakinra decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • antithymocyte globulin equine

              antithymocyte globulin equine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • azathioprine

              azathioprine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • basiliximab

              basiliximab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • belimumab

              belimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • budesonide

              budesonide decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • canakinumab

              canakinumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • certolizumab pegol

              certolizumab pegol decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • chloroquine

              chloroquine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • cortisone

              cortisone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • cyclosporine

              cyclosporine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. If possible, complete all age-appropriate vaccinations at least 2 weeks before initiating immunosuppressant therapy. Patients vaccinated <14 days before starting immunosuppressive therapy or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Longer waiting periods may be required for drugs that maintain their immunosuppressive effects for more than 3 months after discontinuation (eg, ocrelizumab). .

            • deflazacort

              deflazacort decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • dexamethasone

              dexamethasone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • etanercept

              etanercept decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • everolimus

              everolimus decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • fludrocortisone

              fludrocortisone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • glatiramer

              glatiramer decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • golimumab

              golimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • hydrocortisone

              hydrocortisone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • ibrutinib

              ibrutinib decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ifosfamide

              ifosfamide decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • infliximab

              infliximab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • leflunomide

              leflunomide decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • lomustine

              lomustine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mechlorethamine

              mechlorethamine decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • melphalan

              melphalan decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • mercaptopurine

              mercaptopurine decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • methotrexate

              methotrexate decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • methylprednisolone

              methylprednisolone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • muromonab CD3

              muromonab CD3 decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • mycophenolate

              mycophenolate decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. When initiating systemic corticosteriod therapy, wait 2 weeks after an inactivated vaccine.

            • oseltamivir

              oseltamivir decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Avoid administration of live attenuated influenza vaccine intranasal within 2 weeks before or 48 hours after administration of oseltamivir, unless medically indicated.

            • oxaliplatin

              oxaliplatin decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ponesimod

              ponesimod decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.

            • prednisolone

              prednisolone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • prednisone

              prednisone decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • procarbazine

              procarbazine decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • rilonacept

              rilonacept decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • sirolimus

              sirolimus decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • tacrolimus

              tacrolimus decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • temsirolimus

              temsirolimus decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • tocilizumab

              tocilizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • voclosporin

              voclosporin decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.

            Minor (2)

            • amantadine

              amantadine decreases levels of influenza virus vaccine quadrivalent, recombinant by Other (see comment). Minor/Significance Unknown. Comment: Because of its antiviral properties, amantadine may interfere with the efficacy of live attenuated influenza vaccines (LAIV). Coadministration of LAIV and amantadine is not recommended. Inactivated influenza vaccines may be used, as appropriate.

            • ozanimod

              ozanimod decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

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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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            Images

            No images available for this drug.
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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.