Trumenba®

Product Overview

• Brand Name: Trumenba®
• Type: Meningococcal Group B Vaccine (bivalent recombinant lipoprotein [rLP2086])
• Form: Suspension for injection
• Dosage Form/Strength: 0.5 mL dose containing:
  • Neisseria meningitidis serogroup B rLP2086 subfamily A 60 mcg
  • Neisseria meningitidis serogroup B rLP2086 subfamily B 60 mcg
• Manufacturer: Pfizer Canada ULC

Indications and Clinical Use

• Purpose: Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years.

Contraindications

• Hypersensitivity: Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or previous dose of Trumenba.

Warnings and Precautions

• General:
  • Ensure medical treatment for anaphylactic events is available.
  • Syncope (fainting) may occur; procedures should be in place to prevent injury.
  • Administer intramuscularly, not intravenously, intradermally, or subcutaneously.
• Hematologic: Caution in individuals with thrombocytopenia or coagulation disorders.
• Immune: Limited data in immunocompromised individuals; efficacy may be reduced.
• Special Populations:
• Pregnant Women: No data; use only if benefits outweigh risks.
• Nursing Women: Unknown if excreted in human milk; use only if benefits outweigh risks.
• Pediatrics (<10 years): Safety and efficacy not established.
• Geriatrics (>65 years): Not studied.

Adverse Reactions

• Common Adverse Reactions: Pain at the injection site, fatigue, headache, and muscle pain.
• Serious Adverse Events (SAEs): Reported by 1.6% of subjects receiving Trumenba in clinical trials.
• Post-Market Reactions: Allergic reactions, syncope.

Dosage and Administration

• Standard Schedule:
  • 2 doses (0.5 mL each) administered at 0 and 6 months.
• For Increased Risk Individuals:
  • 2 doses (0.5 mL each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose.
• Administration: Intramuscular injection, preferably in the deltoid muscle.

Storage and Stability

• Storage Temperature: 2°C to 8°C (refrigeration).
• Stability: Stable up to 25°C for 4 days; do not freeze.
• Special Handling: Dispose of any unused product or waste according to local requirements.

Clinical Trials and Immunogenicity

• Immunogenicity: Evaluated in 11 clinical trials with 20,803 subjects. Demonstrated high immune response and safety profile.
• Concomitant Vaccine Administration: Can be given with HPV4, MCV4, and Tdap vaccines without affecting immunogenicity.