TRUMENBA- meningococcal group b vaccine injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN (UNII: 583WCD0IZI) (NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN - UNII:583WCD0IZI), NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN (UNII: 7MBD4K530D) (NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN - UNII:7MBD4K530D)

Available from:

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

INN (International Name):

NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN

Composition:

NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN 60 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

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. Severe allergic reaction (e.g. anaphylaxis) to any component of Trumenba [see Description (11)] . Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of Trumenba in pregnant women. Available human data on Trumenba administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Two developmental toxicity studies were performed in female rabbits administered Trumenba prior to mating and during gestation. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL). These studies revealed no evidence of harm to the fet

Product summary:

Trumenba is supplied in the following strengths and package configurations: Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-0100-10. Prefilled Syringe, 1 Dose (5 per package) – NDC 0005-0100-05. Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-0100-02 (This Package Not for Sale). After shipping, Trumenba may arrive at temperatures between 2°C to 25°C (36°F to 77°F). The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex. Upon receipt, store refrigerated at 2°C to 8°C (36°F to 46°F). Store syringes in the refrigerator horizontally (laying flat on the shelf) to minimize the re-dispersion time. Do not freeze. Discard if the vaccine has been frozen.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

TRUMENBA- MENINGOCOCCAL GROUP B VACCINE INJECTION, SUSPENSION
WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS LLC
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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
▪
▪
▪
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
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
®
For intramuscu