HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRUMENBA safely and effectively. See full prescribing information for TRUMENBA.
TRUMENBA® (Meningococcal Group B Vaccine)
Suspension for intramuscular injection
Initial U.S. Approval: 2014
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age. (1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3)
Severe allergic reaction (e.g., anaphylaxis) to any component of Trumenba. (4)
WARNINGS AND PRECAUTIONS
Syncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting. (5.4)
The most common solicited adverse reactions in adolescents and young adults were pain at the injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness have not been established in children <10 years of age. In a clinical study, 90% of infants <12 months of age who were vaccinated with a reduced dosage formulation had fever. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
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