BEXSERO- neisseria meningitidis serogroup b nhba fusion protein antigen, neisseria meningitidis serogroup b fhbp fusion protein antigen and neisseria meningitidis serogroup b nada protein antigen injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN (UNII: 28E911Y7AE) (NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN - UNII:28E911Y7AE), NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN (UNII: 25DB599G64) (NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN - UNII:25DB599G64), NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN (UNII: 1S25R442RS) (NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN - UNII:1S25R442RS), NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN (UNII: 91523M4S24) (NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE ANTIGEN - UNII:91523M4S24)

Available from:

GlaxoSmithKline Biologicals SA

INN (International Name):

NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN

Composition:

NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN 50 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years. Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed. Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of BEXSERO in pregnant women in the U.S. Available human data on BEXSERO administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study was performed in female rabbits administered BEXSERO prior to mating and during gestation. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). This study revealed no adverse effects on fetal or pre-weaning development due to BEXSERO (see Data) . Data Animal Data: In a developmental toxicity study, female rabbits were administered BEXSERO by intramuscular injection on Days 29, 15, and 1 prior to mating and on Gestation Days 7 and 20. The total dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). No adverse effects on pre-weaning development up to Postnatal Day 29 were observed. There were no fetal malformations or variations observed. Risk Summary It is not known whether the vaccine components of BEXSERO are excreted in human milk. Available data are not sufficient to assess the effects of BEXSERO 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 BEXSERO and any potential adverse effects on the breastfed child from BEXSERO 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 BEXSERO have not been established in children younger than 10 years. Safety and effectiveness of BEXSERO have not been established in adults older than 65 years.

Product summary:

BEXSERO is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. Presentation Carton NDC Number Components Pre-filled syringe       Carton of 10 syringes 58160-976-20 0.5-mL single-dose prefilled syringe NDC 58160-976-02 Do not freeze. Discard if the vaccine has been frozen. Store refrigerated, at 36°F to 46°F (2°C to 8°C). Protect from light. Do not use after the expiration date.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BEXSERO- NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN
ANTIGEN,
NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN AND
NEISSERIA
MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN INJECTION, SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BEXSERO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BEXSERO.
BEXSERO (MENINGOCOCCAL GROUP B VACCINE) SUSPENSION, FOR INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.3) - Removed
4/2023
INDICATIONS AND USAGE
BEXSERO is a vaccine indicated for active immunization to prevent
invasive disease caused by _Neisseria_
_meningitidis_ serogroup B. BEXSERO is approved for use in individuals
aged 10 through 25 years. (1)
Approval of BEXSERO is based on demonstration of immune response, as
measured by serum bactericidal
activity against three serogroup B strains representative of prevalent
strains in the United States. The
effectiveness of BEXSERO against diverse serogroup B strains has not
been confirmed. (1)
DOSAGE AND ADMINISTRATION
For intramuscular use only. (2)
Administer 2 doses (0.5-mL each) of BEXSERO at least 1 month apart.
(2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for intramuscular injection in 0.5-mL single-dose prefilled
syringes. (3)
CONTRAINDICATIONS
Hypersensitivity, including severe allergic reaction, to any component
of the vaccine, or after a previous
dose of BEXSERO. (4)
ADVERSE REACTIONS
The most common solicited adverse reactions observed in clinical
trials were pain at the injection site
(≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%),
headache (≥33%), induration (≥28%),
nausea (≥18%), and arthralgia (≥13%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDI