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

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • ofatumumab SC

                ofatumumab SC decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine 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.

              Monitor Closely (2)

              • cyclosporine

                cyclosporine decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine 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). .

              • voclosporin

                voclosporin decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine 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 (0)

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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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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                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.
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                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.