Zutectra

/ Kamada

In HBV-DNA negative adults at least one week after liver transplantation:
Subcutaneous injections per week or fortnightly according to serum anti-HBs trough levels.
Prior to the initiation of subcutaneous treatment with this drug, 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 anti-HBs 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.
Paediatric population
There is no relevant indication for use of this drug in children under the age of 18.
Method of administration
For subcutaneous use only.
Precautions to be taken before handling or administering the medicinal product
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.

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 re-infection prophylaxis.

Hypersensitivity to the active substance or to any of the excipients or to human immunoglobulins. In particular, in very rare cases of IgA deficiency when the patient to be treated has antibodies against IgA.
This medicinal product must not be administered intravascularly.

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment.
Ensure that this drug is not administered into a blood vessel, because of the risk of shock.
If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
There is no data about efficacy in post-exposure prophylaxis.
Hypersensitivity
True hypersensitivity reactions are rare.
This medicinal product contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with this drug against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Potential complications can often be avoided by ensuring that patients:
– are not sensitive to human normal immunoglobulin, by initially injecting the product slowly;
– are carefully monitored for any symptoms throughout the injection. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative product or when there has been a long interval since the previous injection should be monitored during the first injection and for the first hour after the first injection, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs’ test).
Transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV). The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

Common: Injection site pain, injection site urticaria, injection site haematoma, injection site erythema.
See prescribing information for full details.

Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months. After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.

Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Breast-feeding
The safety of this medicinal product for use in breast-feeding has not been established in controlled clinical trials and therefore should only be given with caution to breast-feeding mothers.
Fertility
No fertility studies have been performed.

Consequences of an overdose are not known.

Store and transport refrigerated (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.