HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 INDICATIONS AND USAGETrumenba 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 STRENGTHSSuspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3) CONTRAINDICATIONSSevere allergic reaction (e.g., anaphylaxis) to any component of Trumenba. (4) WARNINGS AND PRECAUTIONSSyncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting. (5.4) ADVERSE REACTIONSThe 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) USE IN SPECIFIC POPULATIONSPediatric 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. Revised: 6/2024 |
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 INDICATIONS AND USAGETrumenba 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 STRENGTHSSuspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3) CONTRAINDICATIONSSevere allergic reaction (e.g., anaphylaxis) to any component of Trumenba. (4) WARNINGS AND PRECAUTIONSSyncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting. (5.4) ADVERSE REACTIONSThe 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) USE IN SPECIFIC POPULATIONSPediatric 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. Revised: 6/2024 |
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