Casa Physicians Alliance News

Pfizer - Trumenba Recent Major Changes for Dosage and Adminstration - Two Dose Schedule

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRUMENBA safely and effectively.

To see full prescribing information for TRUMENBA® CLICK HERE :

(Meningococcal Group B Vaccine) Suspension for intramuscular injection
 Initial U.S. Approval: 2014

Dosage and Administration, Dose and Schedule [4/2016]

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) § Approval of Trumenba is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of Trumenba against diverse serogroup B strains has not been confirmed.

For intramuscular use only.

Three-dose schedule: Administer a dose (0.5 mL) at 0, 1-2, and 6-months.

Two-dose schedule: Administer a dose (0.5 mL) at 0 and 6 months.

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

Severe allergic reaction after a previous dose of Trumenba.

The most common solicited adverse reactions were pain at the injection site (≥85%), fatigue (≥40%), headache (≥35%), muscle pain (≥30%), and chills (≥15%).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985
or VAERS at 1-800-822-7967 or .

Pregnancy: Trumenba should be used during pregnancy only if clearly needed.

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. 

Posted by Chris Dixon on 22nd April, 2016 | Comments | Trackbacks
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CASA Physicians Alliance - A Group Purchasing Organization for Physicians, was started 16 years ago for the sole purpose of joining physicians into a large buying group to obtain the best possible discounts on pediatric, adolescent and adult vaccines. Since then, CASA has forged very successful partnerships on behalf of our members.


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