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Drug intelligence / Profile preview
Fendrix
- Development stage
- Unknown
- Lead developer
- GSK
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Administration
- Intramuscular
01
Overview
Fendrix is a recombinant hepatitis B vaccine developed by GSK, specifically indicated for active immunization against hepatitis B virus (HBV) in patients aged 15 years and older with renal insufficiency, including pre-hemodialysis and hemodialysis patients. The vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced in *Saccharomyces cerevisiae* yeast cells. Its enhanced immunogenicity in immunocompromised populations is attributed to the proprietary AS04 adjuvant system, which combines 3-O-desacyl-4'-monophosphoryl lipid A (MPL), a detoxified derivative of lipopolysaccharide, with aluminum phosphate. Fendrix is administered intramuscularly, typically following a four-dose schedule at 0, 1, 2, and 6 months, to stimulate the production of protective anti-HBs antibodies.
- Brand names
- Fendrix
- Other names
- Hepatitis B vaccine (recombinant, adjuvanted, adsorbed)AS04-adjuvanted hepatitis B vaccineAS-04-adjuvanted hepatitis B vaccineAS 04-adjuvanted hepatitis B vaccineHBV-AS04HBV-AS-04HBV-AS 04
02
Targets
HBsAg (Hepatitis B surface antigen)
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