HEPATECT CP SOLUTION FOR INFUSION 50 IU/ML [SIN14652P]

Product Info

HEPATECT CP SOLUTION FOR INFUSION 50 IU/ML

[SIN14652P]

4.1 Therapeutic indications
Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.

Immunoprophylaxis of hepatitis B

• In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown).

• In haemodialysed patients, until vaccination has become effective.

• In the newborn of a hepatitis B virus carrier-mother.

• In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.

4.2 Posology and method of administration
Posology

Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure:
In adults:
10 000 international units on the day of transplantation, peri-operatively then 2000–10 000 international units (40–200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100–150 international units/l in HBV-DNA negative patients and above 500 international units/l in HBV-DNA positive patients.

In children:
Posology should be adjusted according to body surface area, on the basis of 10 000 international units/1.73 m².

Immunoprophylaxis of hepatitis B:

• Prevention of hepatitis B in case of accidental exposure in non-immunised subjects:
  At least 500 international units (10 ml), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24 – 72 hours.

• Immunoprophylaxis of hepatitis B in haemodialysed patients:
  8–12 international units (0.16–0.24 ml)/kg with a maximum of 500 international units (10 ml), every 2 months until seroconversion following vaccination.

• Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30–100 international units (0.6–2 ml)/kg. The hepatitis B immunoglobulin administration may be repeated until seroconversion following vaccination.

In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected on the same day as human hepatitis B immunoglobulin, however in different sites.

In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 international units (10 ml) to adults and 8 international units (0.16 ml)/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 milli-international units/mL.

Hepatic impairment
No evidence is available to require a dose adjustment.

Renal impairment
No dose adjustment unless clinically warranted, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Elderly
No dose adjustment unless clinically warranted, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of administration
Intravenous use
Hepatect CP should be infused intravenously at an initial rate of 0.1 ml/kg/hr for 10 minutes. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg/hr.

Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that Hepatect CP intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.