influenza virus vaccine quadrivalent, intranasal (Rx)

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Brand and Other Names:FluMist Quadrivalent

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intranasal suspension

  • 0.2mL (prefilled single use sprayer)
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Influenza Prophylaxis

Indicated for prevention of influenza A and B infection in individuals aged 2-49 years

2-49 years: 0.2 mL/dose (0.1 mL/nostril); 1 dose/season

Intranasal administration for age ≥50 years: Safety and efficacy not established

ALERT: ACIP states intranasal flu vaccine should NOT be used for 2016-2017 season

  • June 22, 2016: CDC’s Advisory Committee on Immunization Practices (ACIP) voted that live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine, should not be used during the 2016-2017 flu season
  • This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016
  • In late May 2016, preliminary data on the effectiveness of LAIV among children aged 2-17 yr during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network
  • That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3% (with a 95% Confidence Interval (CI) of -49% to 37%); this 3% estimate means no protective benefit could be measured
  • In comparison, IIV (flu shots) had a VE estimate of 63% (with a 95% CI of 52-72%) against any flu virus among children aged 2-17 yr
  • http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

Dosing Considerations

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

A/California/7/2009 (H1N1)-like (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 (B/Victoria lineage vaccine virus)

Dosage Forms & Strengths

intranasal suspension

  • 0.2mL (prefilled single use sprayer)
more...

Influenza Prophylaxis

Indicated for prevention of influenza A and B infection individuals aged 2-49 years

<2 year: Safety and efficacy not established

2-8 years: 0.2 mL/dose (0.1 mL in each nostril) x1-2 doses/season (see Administration)

≥9 years: As in adults; 0.2 mL/dose (0.1 mL/nostril); 1 dose/season

ALERT: ACIP states intranasal flu vaccine should NOT be used for 2016-2017 season

  • June 22, 2016: CDC’s Advisory Committee on Immunization Practices (ACIP) voted that live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine, should not be used during the 2016-2017 flu season
  • This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016
  • In late May 2016, preliminary data on the effectiveness of LAIV among children aged 2-17 yr during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network
  • That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3% (with a 95% Confidence Interval (CI) of -49% to 37%); this 3% estimate means no protective benefit could be measured
  • In comparison, IIV (flu shots) had a VE estimate of 63% (with a 95% CI of 52-72%) against any flu virus among children aged 2-17 yr
  • http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

Dosing Considerations

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

A/California/7/2009 (H1N1)-like (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 (B/Victoria lineage vaccine virus)

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Interactions

Interaction Checker

and influenza virus vaccine quadrivalent, intranasal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Adults

            • Runny nose (41-45%)
            • Headache (41-45%)
            • Sore throat (26-30%)
            • Weakness (26-30%)
            • Myalgia (16-20%)
            • Cough (11-15%)

            Children

            • Runny nose/nasal congestion (46-50%)
            • Cough (36-40%)
            • Irritability (16-20%)
            • Headache (16-20%)

            1-10%

            Adults

            • Chills (6-10%)
            • Nasal congestion (6-10%)
            • Sinusitis (2-5%)
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            Warnings

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            Contraindications

            Hypersensitivity to eggs, sulfites

            IV/IM administration

            Children/adolescents receiving aspirin

            Asthma, reactive airway disease

            Diabetes, renal dysfunction

            Hemoglobinopathies

            Immunodeficiency diseases

            Patients on immunosuppressants

            Any chronic pulmonary/cardivascular disorder

            Cautions

            Do not administer within 2 wk of inactivated vaccine or 4 week of live virus vaccine

            Treatment for anaphylactoid and/or hypersensitivity reactions must be present during vaccine use

            Use caution in patients with history of Guillain-Barre

            Nasal congestion may impair delivery of vaccine (avoid use)

            Not recommended in patients with neurologic or neuromuscular disorders

            Avoid use in children aged 2 through 4 years who had wheezing in the past 12 months, or those who have any other underlying medical conditions that predispose them to influenza complications

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            Pregnancy & Lactation

            Pregnancy Category: C

            Live virus vaccine; indicated for nonpregnant adolescents and adults

            Lactation: unknown; avoid intranasal live vaccine while breastfeeding newborn

            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

            Vaccine; vaccines convey active immunity via stimulation of production of endogenously produced antibodies

            Pharmacokinetics

            Onset: Three weeks after vaccination

            Duration: 6 months or more

            Distribution: Nasal cavity, stomach, brain, and lungs

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            Administration

            Instructions

            Administer at beginning of influenza season

            Dosing algorithm for children aged 2 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
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            Images

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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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