FENDRIX Suspension for injection Ref.[28269] Active ingredients: Hepatitis B, purified antigen

Pharmacotherapeutic group: Vaccines, hepatitis vaccines
ATC code: J07BC01

Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies). An anti-HBs antibody titre ≥10 mIU/ml correlates with protection to HBV infection.

It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

Immunological data

In pre-haemodialysis and haemodialysis patients

In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), protective levels of specific humoral antibodies (anti-HBs titres ≥10 mIU/ml) were observed in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 52.4% of patients in the control group who received a double dose of a commercially available hepatitis B vaccine (N = 83) for this population.

At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.

After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were seroprotected (≥10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who received the commercially available hepatitis B vaccine.

At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.

Antibody persistence

In pre-haemodialysis and haemodialysis patients

Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month primary course of Fendrix in pre-haemodialysis and haemodialysis patients. At month 36, 80.4% of these patients retained protective antibody levels (anti-HBs titres ≥10 mIU/ml), as compared to 51.3% of patients who received a commercially available hepatitis B vaccine.

At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres 100 mIU/ml respectively.