Tuesday, April 11, 2017 by Gregory Van Dyke
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BEXSERO safely and effectively. See full prescribing information for BEXSERO.
See full insert sheet at this link at the Natural News Reference website.
BEXSERO® (Meningococcal Group B Vaccine)
Suspension for intramuscular injection
Initial U.S. Approval: 2015
INGREDIENTS AND EXCIPIENTS
BEXSERO (Meningococcal Group B Vaccine) is a sterile, white, opalescent, suspension for intramuscular injection. Each 0.5 mL dose of BEXSERO is formulated to contain 50 micrograms each of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), 25 micrograms of Outer Membrane Vesicles (OMV), 1.5 mg aluminum hydroxide (0.519 mg of Al3+), 3.125 mg sodium chloride, 0.776 mg histidine, and 10 mg sucrose at pH 6.4 – 6.7.
The NadA component is a fragment of the full-length protein derived from N. meningitidis strain 2996 (peptide 8 variant 2/3)5 . The NHBA component is a recombinant fusion protein comprised of NHBA (peptide 2)5 and accessory protein 953 derived from N. meningitidis strains NZ98/254 and 2996, respectively. The fHbp component is a recombinant fusion protein comprised of fHbp (variant 1.1)5 and the accessory protein 936 derived from N. meningitidis strains MC58 and 2996, respectively. These three recombinant proteins are individually produced in Escherichia coli and purified through a series of column chromatography steps. The OMV antigenic component is produced by fermentation of N. meningitidis strain NZ98/254 (expressing outer membrane protein PorA serosubtype P1.4) 6 , followed by inactivation of the bacteria by deoxycholate, which also mediates vesicle formation. The antigens are adsorbed onto aluminum hydroxide .
Each dose contains less than 0.01 micrograms kanamycin (by calculation).
INDICATIONS AND USAGE
BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age. (1)
Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed. (1)
DOSAGE AND ADMINISTRATION
For intramuscular use only. (2)
Administer two doses (0.5 mL each) of BEXSERO at least 1 month apart. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for intramuscular injection in 0.5 mL single-dose pre-filled syringes. (3)
Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO. (4)
WARNINGS AND PRECAUTIONS
The tip caps of the pre-filled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. (5.3)
The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥ 28%), nausea (≥18%), and arthralgia (≥13%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Vaccines at 1-877-683-4732 or VAERS at 1-800- 822-7967 or http://vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
Pregnancy Category B
Reproduction studies have been performed in rabbits at doses up to 15 times the human dose on a body weight basis and have revealed no evidence of impaired fertility in females or harm to the fetus due to BEXSERO. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive.
Pregnancy Registry for BEXSERO
Novartis Vaccines and Diagnostics Inc. maintains a pregnancy registry to monitor the fetal outcomes of pregnant women exposed to BEXSERO. Health care providers are encouraged to register women who receive BEXSERO during pregnancy by calling 1-877-683-4732.
It is not known whether BEXSERO is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BEXSERO is administered to a nursing woman.
Safety and effectiveness of BEXSERO have not been established in children younger than 10 years of age.
Safety and effectiveness of BEXSERO have not been established in adults older than 65 years of age.