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 :http://labeling.pfizer.com/ShowLabeling.aspx?id=1796
(Meningococcal Group B Vaccine) Suspension for intramuscular injection
Initial U.S. Approval: 2014
RECENT MAJOR CHANGES
Dosage and Administration, Dose and Schedule [4/2016]
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) § 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.
DOSAGE AND ADMINISTRATION
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.
DOSAGE FORMS AND STRENGTHS
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 http://vaers.hhs.gov .
USE IN SPECIFIC POPULATIONS
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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