Meningococcal Group B Vaccine (2 dose)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Meningococcal Group B Vaccine (2 dose) is a vaccine that is FDA approved for the prevention of invasive disease caused by Neisseria meningitidis serogroup B. Common adverse reactions include pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥ 28%), nausea (≥18%), and arthralgia (≥13%).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Meningococcal Group B Vaccine is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Meningococcal Group B Vaccine is approved for use in individuals 10 through 25 years of age.
Approval of Meningococcal Group B Vaccine 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 Meningococcal Group B Vaccine against diverse serogroup B strains has not been confirmed.
Dosage
- For intramuscular use only.
- Administer two doses (0.5 mL each) of Meningococcal Group B Vaccine at least 1 month apart.
Use of Meningococcal Group B Vaccine with other Meningococcal Group B Vaccines Sufficient data are not available on the safety and effectiveness of using Meningococcal Group B Vaccine and other meningococcal group B vaccines interchangeably to complete the vaccination series.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Meningococcal Group B Vaccine (2 dose) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Meningococcal Group B Vaccine (2 dose) in pediatric patients.
Contraindications
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Contraindications in the drug label.
Warnings
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Meningococcal Group B Vaccine (2 dose) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Meningococcal Group B Vaccine (2 dose) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Meningococcal Group B Vaccine (2 dose) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in geriatric settings.
Gender
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Meningococcal Group B Vaccine (2 dose) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Meningococcal Group B Vaccine (2 dose) in patients who are immunocompromised.
Administration and Monitoring
Administration
Shake the syringe immediately before use to form a homogeneous suspension. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.
Administer Meningococcal Group B Vaccine as a 0.5 mL intramuscular injection into the deltoid muscle of the upper arm.
Monitoring
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Meningococcal Group B Vaccine (2 dose) and IV administrations.
Overdosage
There is limited information regarding Meningococcal Group B Vaccine (2 dose) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Mechanism of Action in the drug label.
Structure
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Meningococcal Group B Vaccine (2 dose) How Supplied in the drug label.
Storage
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Meningococcal Group B Vaccine (2 dose) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
BEXSERO®
Look-Alike Drug Names
There is limited information regarding Meningococcal Group B Vaccine (2 dose) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.