MENQUADFI- neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: T4GYX3110D) (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:T4GYX3110D), NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: ZT89E5A103) (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:ZT89E5A103), NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: 4WAN8PQK15) (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:4WAN8PQK15), NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: L77OK410KW) (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN - UNII:L77OK410KW)

Dostupné s:

Sanofi Pasteur Inc.

Podání:

INTRAMUSCULAR

Terapeutické indikace:

MenQuadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is indicated for use in individuals 2 years of age and older. MenQuadfi does not prevent N. meningitidis serogroup B disease. Severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine [see Description (11) ]. 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 All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There are no clinical studies of MenQuadfi in pregnant women. Available human data on MenQuadfi administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study in female rabbits administered a full human dose (0.5 mL) prior to mating and during gestation period revealed no evidence of harm to the fetus due to MenQuadfi (see Animal Data ). Data Animal Data In a developmental toxicity study, female rabbits received a human dose of MenQuadfi by intramuscular injection on five occasions: 30 days and 10 days prior to mating, gestation days 6, 12 and 27. No adverse effects on pre-weaning development up to post-natal day 35 were observed. There were no vaccine-related fetal malformations or variations observed. Risk Summary It is not known whether MenQuadfi is excreted in human milk. Data are not available to assess the effects of MenQuadfi on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MenQuadfi and any potential adverse effects on the breastfed child from MenQuadfi or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Safety and effectiveness of MenQuadfi have not been established in individuals younger than 2 years of age in the US. A total of 249 participants 65 years of age and older, including 71 participants 75 years of age or older, in Study 4 received one dose of MenQuadfi [see Adverse Reactions (6.1) and Clinical Studies (14.1) ]. MenQuadfi recipients ≥ 65 years of age had lower GMTs and seroresponse rates for all serogroups compared to MenQuadfi recipients 56 through 64 years of age [see Clinical Studies (14.1) ].

Přehled produktů:

MenQuadfi is supplied in a single-dose vial (NDC 49281-590-58): in packages of 1 vial (NDC 49281-590-01); in packages of 5 vials (NDC 49281-590-05); in packages of 10 vials (NDC 49281-590-10). Not all pack sizes may be marketed. The vial stopper is not made with natural rubber latex. Store at 2°C to 8°C (35°F to 46°F). Do not freeze. Do not use vaccine that has been frozen. Do not use after expiration date.

Stav Autorizace:

Biologic Licensing Application

Charakteristika produktu

MENQUADFI- NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE
TETANUS
TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR
POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA
MENINGITIDIS
GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, AND
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS
TOXOID
CONJUGATE ANTIGEN INJECTION, SOLUTION
SANOFI PASTEUR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MENQUADFI® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MENQUADFI.
MENQUADFI, MENINGOCOCCAL (GROUPS A, C, Y, W) CONJUGATE VACCINE
SOLUTION FOR INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
MenQuadfi is a vaccine indicated for active immunization for the
prevention of invasive meningococcal
disease caused by _Neisseria meningitidis_ serogroups A, C, W, and Y.
MenQuadfi is approved for use in
individuals 2 years of age and older. (1)
MenQuadfi does not prevent _N. meningitidis_ serogroup B disease.
DOSAGE AND ADMINISTRATION
0.5 mL dose for intramuscular injection. (2)
Primary Vaccination
Individuals 2 years of age and older: a single dose.
Booster Vaccination
A single dose of MenQuadfi may be administered to individuals 13 years
of age and older who are at
continued risk for meningococcal disease if at least 3 years have
elapsed since a prior dose of
meningococcal (groups A, C, W, Y) conjugate vaccine.
Vaccination Following Prior Dose of Meningococcal Polysaccharide
Vaccine
A single dose of MenQuadfi may be administered if at least 3 years
have elapsed since a prior dose of
meningococcal polysaccharide vaccine.
DOSAGE FORMS AND STRENGTHS
Solution for injection in 0.5 mL single-dose vial. (3)
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, or after a
previous dose of MenQuadfi or any
other tetanus toxoid-containing vaccine. (4)
ADVERSE REACTIONS
Most commonly reported adverse reactions (≥10%) following a primary
dose were a