Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 17 May 2018

Indication(s)

• 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)
• The effectiveness of the two-dose schedule of Trumenba against diverse N. meningitidis serogroup B strains has not been confirmed. (1)

Full Prescribing information

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Advisory information

contraindications
• Severe allergic reaction after a previous dose of Trumenba. (4)
Adverse reactions

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)

Usage information

Dosing and administration

• For intramuscular use only. (2)
Three-dose schedule: Administer a dose (0.5 mL) at 0, 1-2, and 6 months. (2.1)
Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months.
If the second dose is administered earlier than 6 months after the first dose, a third dose should be administered at least 4 months after the second dose. (2.1)

Use in special 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)

More information

Category Value
Authorisation number BLA125549
Orphan designation No
Product NDC 0005-0100
Date First Approved 05-11-2014
Marketing authorisation holder Wyeth Pharmaceuticals, Inc.