meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine (Rx)

Brand and Other Names:MenQuadfi
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection, solution

  • 0.5mL single-dose vial
  • Each 0.5-mL dose contains 10 mcg each of meningococcal A, C, W, and Y polysaccharide antigens conjugated to ~55 mcg tetanus toxoid protein carrier; also contains 3.35 mg sodium chloride (0.67%) and 1.23 mg sodium acetate (30 mM)
  • No preservative or adjuvant is added

Meningococcal Immunization

Indicated for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged ≥2 years

Primary vaccination: 0.5 mL IM x1 dose

Booster for individuals at continued risk

  • Consider in individuals aged ≥15 yr if at least 4 yr have elapsed since a prior dose of meningococcal (groups A, C, W, Y) conjugate vaccine
  • 0.5 mL IM x1 dose

Dosing Considerations

Does not prevent N meningitidisserogroup B disease

Dosage Forms & Strengths

injection, solution

  • 0.5mL single-dose vial
  • Each 0.5-mL dose contains 10 mcg each of meningococcal A, C, W, and Y polysaccharide antigens conjugated to ~55 mcg tetanus toxoid protein carrier; also contains 3.35 mg sodium chloride (0.67%) and 1.23 mg sodium acetate (30 mM)
  • No preservative or adjuvant is added

Meningococcal Immunization

Indicated for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in persons aged ≥2 years

<2 years: Safety and efficacy not established

2 years or older

  • Primary vaccination: 0.5 mL IM x1 dose
  • Booster for individuals at continued risk
    • Consider in individuals aged ≥15 yr if at least 4 yr have elapsed since a prior dose of meningococcal (groups A, C, W, Y) conjugate vaccine
    • 0.5 mL IM x1 dose

Dosing Considerations

Does not prevent N meningitidisserogroup B disease

Vaccine recipients aged ≥65 yr had lower geometric mean antibody titers and seroresponse rates for all serogroups compared with recipients aged 56-64 yr

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Interactions

Interaction Checker

and meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% All Grades

            Children aged 2-9 yr

            • Injection site pain (38.6%)
            • Injection site erythema (22.6%)
            • Malaise (21.1%)
            • Myalgia (20.1%)
            • Injection site swelling (13.8%)
            • Headache (12.5%)

            Adolescents aged 10-17 yr

            • Injection site pain (45.2%)
            • Myalgia (35.3%)
            • Headache (30.2%)
            • Malaise (26%)

            Adults aged 18-55 yr

            • Injection site pain (41.9%)
            • Myalgia (35.6%)
            • Headache (29%)
            • Malaise (22.9%)

            Adults aged 56 yr or older

            • Injection site pain (25.5%)
            • Myalgia (21.9%)
            • Headache (19%)
            • Malaise (14.5%)

            1-10% All Grades

            Children aged 2-9 yr

            • Fever (1.9%)

            Adolescents aged 10-17 yr

            • Injection site swelling (5.4%)
            • Injection site erythema (5%)
            • Fever (1.4%)

            Adults aged 18-55 yr

            • Injection site erythema (5.1%)
            • Injection site swelling (4.3%)
            • Fever (1.4%)

            Adults aged 56 yr or older

            • Injection site erythema (5.2%)
            • Injection site swelling (4.5%)
            • Fever (2.1%)

            1-10% Grade 3

            Children aged 2-9 yr

            • Injection site erythema (3.1%)
            • Malaise (1.8%)
            • Injection site swelling (1.4%)

            Adolescents aged 10-17 yr

            • Malaise (2.2%)
            • Headache (1.8%)
            • Myalgia (1.6%)
            • Injection site pain (1.4%)

            Adults aged 18-55 yr

            • Myalgia (3.6%)
            • Headache (2.9%)
            • Malaise (2.9%)
            • Injection site pain (1.9%)

            Adults aged 56 yr or older

            • Myalgia (1.6%)
            • Malaise (1.4%)

            <1% Grade 3

            Children aged 2-9 yr

            • Injection site pain (0.6%)
            • Myalgia (0.4%)

            Adolescents aged 10-17 yr

            • Injection site erythema (0.4%)
            • Fever (0.4%)
            • Injection site swelling (0.2%)

            Adults aged 18-55 yr

            • Injection site erythema (0.3%)
            • Injection site swelling (0.2%)
            • Fever (0.1%)

            Adults aged 56 yr or older

            • Injection site pain (0.7%)
            • Headache (0.7%)
            • Injection site erythema (0.2%)
            • Fever (0.2%)
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            Warnings

            Contraindications

            Severe allergic reaction to any component of the vaccine after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine

            Cautions

            Acute allergic reactions may occur; appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following vaccine administration

            Syncope can occur following (or before) administration; assure procedures are in place to prevent falling or injury

            Guillain-Barré syndrome reported in temporal relationship following administration of another meningococcal quadrivalent polysaccharide conjugate vaccines

            Immunization with MenQuadfi does not substitute for routine tetanus immunization

            Vaccination may not protect all vaccine recipients

            Altered immunocompetence

            • Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses
            • Persons with certain complement deficiencies or those receiving drugs that inhibit terminal complement activation (eg, eculizumab, ravulizumab) are at increased risk for invasive disease caused by N meningitidis

            Drug interaction overview

            • Coadministration with other vaccines
              • Lower geometric mean antibody concentrations for antibodies to the pertussis antigens filamentous hemagglutinin, pertactin, and fimbriae observed when coadministered with Tdap and HPV, compared with concomitant administration of Tdap and HPV (without MenQuadfi)
            • Immunosuppressive treatment
              • Immunosuppressive therapies may reduce the immune response to meningococcal vaccine
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            Pregnancy & Lactation

            Pregnancy

            Data are not available for exposure during pregnancy in humans

            Pregnancy exposure registry that monitors pregnancy outcomes in females exposed during pregnancy; 1-800-822-2463

            Animal data

            • Female rabbits received a human dose by IM injection on 5 occasions: 30 days and 10 days before mating, gestation days 6, 12, and 27
            • No adverse effects on preweaning development up to postnatal day 35 were observed
            • No vaccine-related fetal malformations or variations were observed

            Lactation

            Unknown if excreted in human milk

            Data are not available to assess effects on breastfed infants or on milk production/excretion

            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

            Meningococcal serogroup A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to tetanus toxoid protein carrier

            Conveys active immunity via stimulation of production of endogenously produced antibodies

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            Administration

            IM Preparation

            Remove vial from refrigerator and inspect visually for particulate matter and/or discoloration; do not use if any of these conditions exist

            Solution should appear clear

            IM Administration

            Administer intramuscularly

            Storage

            Refrigerate at 2-8ºC (35-46ºF)

            Do not freeze

            Do not use vaccine that has been frozen

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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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.