Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start.
The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B reinfection prophylaxis.
In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels.
Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing. Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections on a weekly or fortnightly basis, according to the serum antiHBs concentrations and at the discretion of the physician in charge. Antibody levels >100 IU/l should be maintained.
Patients must be monitored for serum anti-HBs antibody levels regularly. Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
There is no relevant indication for use of Zutectra in children under the age of 18.
For subcutaneous use only.
Injection of the medicinal product by the patient or by caregiver in a home treatment requires training by a physician experienced in the guidance of patients for home treatment. The patient or caregiver will be instructed in injection techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events. A sufficient surveillance period with stable anti-HBs trough serum levels of >100 IU/l as well as a fixed dosage regimen is required: the monitoring schedule of patients anti-HBs antibody levels (see above) needs to be closely followed. In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels >100 IU/l after extended periods between level controls.
Consequences of an overdose are not known.
2 years.
The solution should be administered immediately after opening the syringe.
Store and transport refrigerated (2°C-8°C).
Do not freeze.
Keep the container in the outer carton in order to protect from light.
One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
Pack size of five syringes in a blistered pack.
This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.
The solution can vary from colourless to pale yellow up to light brown.
Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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