Menquadfi

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  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Menquadfi Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Neisseria meningitidis polysaccharide antigens (conjugated to approx. 55mcg of tetanus toxoid protein carrier); 10mcg each of Group A, C, W, and Y; per 0.5mL; soln for IM inj; preservative-free.

    Pharmacological Class

    Meningitis vaccine.

    How Supplied

    Single-dose vials—5

    Manufacturer

    Sanofi Pasteur, Inc.

    Generic Availability

    NO

    Mechanism of Action

    MenQuadfi induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitidis serogroups A, C, W, and Y.

    Menquadfi Indications

    Indications

    Meningitis immunization.

    Menquadfi Dosage and Administration

    Adults and Children

    <2yrs: not established. Give by IM inj only. Primary vaccination: ≥2yrs: 0.5mL once as single inj. Booster vaccination: ≥15yrs: may give a single (0.5mL) dose for those at continued risk, if at least 4yrs have elapsed since the prior dose.

    Menquadfi Contraindications

    Contraindications

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

    Menquadfi Boxed Warnings

    Not Applicable

    Menquadfi Warnings/Precautions

    Warnings/Precautions

    Not for the prevention of N. meningitidis serogroup B disease. Not a substitute for routine tetanus immunization. Have epinephrine inj (1:1000) available. History of Guillain-Barre syndrome. Immunosuppressed. Complement deficiency. Eculizumab therapy. Risk of syncope. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have medical treatment readily available in case of an anaphylactic event following administration.

    Altered Immunocompetence

    • May reduce immune responses in some individuals with altered immunocompetence, including those receiving immunosuppressant therapy.

    • Increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, in persons with certain complement deficiencies and those receiving treatment that inhibits terminal complement activation (eg, eculizumab) even if they develop antibodies following vaccination with MenQuadfi.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting and manage syncope.

    Guillain-Barré Syndrome

    • Consider the potential benefits and risks of administering MenQuadfi in persons with a history of Guillain-Barré Syndrome (GBS).

    • Temporal relationship has been reported with GBS following administration of Menactra.

    Tetanus Immunization

    • MenQuadfi does not substitute for routine tetanus immunization.

    Limitations of Vaccine Effectiveness

    • May not protect all vaccine recipients.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MenQuadfi during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463.

    Risk Summary

    • No clinical studies are available for MenQuadfi administration in pregnant women.

    • Available human data on MenQuadfi are insufficient to inform vaccine-associated risks in pregnancy. 

    Nursing Mother Considerations

    • Unknown whether MenQuadfi is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for MenQuadfi and any potential adverse effects on the breastfed child from MenQuadfi.

    Pediatric Considerations

    • Safety and efficacy of MenQuadfi have not been established in individuals younger than 2 years of age in the US.

    Menquadfi Pharmacokinetics

    See Literature

    Menquadfi Interactions

    Interactions

    Immunosuppressants may get suboptimal response. Concomitant other vaccines: see full labeling.

    Interactions

    Concomitant Administration with Other Vaccines 

    • In a clinical trial in adolescents 10 through 17 years of age, MenQuadfi was administered concomitantly with Tdap and HPV. 

    • When MenQuadfi was co-administered with Tdap and HPV, lower geometric mean antibody concentrations (GMCs) for antibodies to the pertussis antigens filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae (FIM) were observed compared to concomitant administration of Tdap and HPV (without MenQuadfi).

    Immunosuppressive Therapies

    • Immunosuppressive therapies may reduce the suboptimal response. 

    Menquadfi Adverse Reactions

    Adverse Reactions

    Inj site reactions (pain, erythema, swelling), myalgia, headache, malaise.

    Adverse Reactions

    Most commonly reported adverse reactions (≥10%) following a primary dose were as follows:

    • Children 2 through 9 years of age: pain (38.6%), erythema (22.6%), and swelling (13.8%) at the injection site; malaise (21.1%), myalgia (20.1%), and headache (12.5%).

    • Adolescents aged 10 through 17 years of age: injection site pain (34.8%– 45.2%), myalgia (27.4%–35.3%), headache (26.5%–30.2%), and malaise (19.4%–26.0%).

    • Adults aged 18 through 55 years: injection site pain (41.9%), myalgia (35.6%), headache (29.0%), and malaise (22.9%). 

    • Adults 56 years of age and older: pain at the injection site (25.5%), myalgia (21.9%), headache (19.0%), and malaise (14.5%).

    In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination.

    Menquadfi Clinical Trials

    Clinical Trials

    Primary Vaccination

    Immunogenicity in Children 2 through 9 Years of Age

    • Study 1 (NCT03077438) – The immunogenicity of MenQuadfi was compared to Menveo in participants 2 through 9 years of age. MenQuadfi achieved noninferiority to Menveo for seroresponse rates for all 4 serogroups.

    Immunogenicity in Adolescents 10 through 17 Years of Age 

    • Study 2  (NCT02199691) – The immunogenicity of MenQuadfi was compared to Menveo in healthy meningococcal vaccine naïve participants 10 through 17 years of age. Participants received either MenQuadfi alone, Menveo alone, MenQuadfi co-administered with Tdap, and HPV, or Tdap and HPV alone. MenQuadfi achieved noninferiority to Menveo for seroresponse rates for all 4 serogroups.

    • Study 3 (NCT02842853) – The immunogenicity of MenQuadfi was compared to Menactra in healthy meningococcal-naïve participants 10 through 17 years of age. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.

    Immunogenicity in Adults 18 through 55 Years of Age

    • Study 3 (NCT02842853) – The immunogenicity of MenQuadfi was compared to Menactra in participants 18 through 55 years of age. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.

    Immunogenicity in Adults 56 Years of Age and Older 

    • Study 4 (NCT02842866) – The immunogenicity of MenQuadfi was compared to Menomune in participants 56 years of age and older. Seroresponse rates for MenQuadfi were noninferior to Menomune for all serogroups.

     

    Booster

    • Study 5 (NCT02752906) – The immunogenicity of a booster dose of MenQuadfi was compared to a booster dose of Menactra in participants 15 years of age and older who previously received a primary dose of Menveo or Menactra 4 to 10 years prior. Seroresponse rates for MenQuadfi were noninferior to Menactra for all serogroups.

    Menquadfi Note

    Notes

    To enroll pregnant patients or obtain information call (800) 822-2463.

    Menquadfi Patient Counseling

    Patient Counseling

    Inform the patients, parents or guardians about: 

    • Potential benefits and risks of immunization with MenQuadfi. 

    • Potential for adverse reactions that have been temporally associated with administration of MenQuadfi or other vaccines containing similar components. 

    • Reporting any adverse reactions to their healthcare provider. 

    • The Sanofi Pasteur Inc. Pregnancy Registry, as appropriate.

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