TRUMENBA® Highlights

(Meningococcal Group B Vaccine)

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, removal of statement regarding limitations of two-dose schedule of Trumenba (1)11/2021
Dosage and Administration, Dose and Schedule (2.1)11/2021

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

  • For intramuscular use only. (2)
  • 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)
  • Three-dose schedule: Administer a dose (0.5 mL) at 0, 1–2, and 6 months. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3)

CONTRAINDICATIONS

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)

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)


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.

Revised: 11/2021

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Highlights

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, removal of statement regarding limitations of two-dose schedule of Trumenba (1)11/2021
Dosage and Administration, Dose and Schedule (2.1)11/2021

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

  • For intramuscular use only. (2)
  • 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)
  • Three-dose schedule: Administer a dose (0.5 mL) at 0, 1–2, and 6 months. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for intramuscular injection in 0.5 mL single-dose prefilled syringe. (3)

CONTRAINDICATIONS

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)

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)


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.

Revised: 11/2021

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FDA Medwatch

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