Pharmacotherapeutic group: Specific immunoglobulins. ATC code: J06BB04.
Pharmacology: Pharmacodynamics: Fovepta contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Clinical experience: In an open, randomised parallel study a single dose (200 IU, administered < 12 hours after birth) of Fovepta was administered by subcutaneous (SC) or intramuscular (IM) injection to 34 neonates (17 SC and 17 IM) of a gestational age ≥ 37+0 weeks born to HBsAg positive mothers. Serum anti-HBs concentrations ≥ 100 IU/L (primary efficacy endpoint) were found in 30/31 (16 SC vs. 17 IM) newborns. Mean anti-HBs levels were comparable with 278.1 ± 92.4 IU/L (280.2) SC vs. 294.1 ± 112.6 IU/L (260.5) IM.
Both routes of administration were considered to be effective, safe and well-tolerated.
Pharmacokinetics: Fovepta is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days.
Fovepta has a half-life of about 3-4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
Toxicology: Preclinical safety data: Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.
In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Fovepta.
No other non-clinical trials have been carried out.