Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- elivaldogene autotemcel
elivaldogene autotemcel, meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- 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.
- teplizumab
teplizumab decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.
Monitor Closely (5)
- 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). .
- satralizumab
satralizumab decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .
- tralokinumab
tralokinumab will decrease the level or effect of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.
- ublituximab
ublituximab decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
- 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)
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%)
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
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.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
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
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