What is Zutectra?
Zutectra is a solution for injection. The medicine is available in a pre-filled syringe containing 500 international units (IU) of the active substance, human hepatitis B immunoglobulin.
What is Zutectra used for?
Zutectra is used in adults who have undergone liver transplantation following liver failure caused by hepatitis B infection. Zutectra is used to prevent reinfection with hepatitis B virus. Ordinary antiviral drugs can be used with Zutectra to prevent re-infection with hepatitis B.
The medicine can only be obtained with a prescription.
How is Zutectra used?
Zutectra is given as an injection under the skin once a week. Patients weighing less than 75 kg must receive 500 IU once a week. The dose can be increased up to a maximum of 1 000 IU. Patients weighing 75 kg or more should receive 1 000 IU once a week.
Treatment with Zutectra starts at least six months after liver transplantation. Before starting Zutectra, the patient will need to receive medicines that contain the same active ingredient as Zutectra, but given into a vein, to produce stable levels of the active substance in the blood. Patients should be monitored regularly during treatment with Zutectra to verify that the levels of the active substance in the blood remain sufficiently high.
Zutectra injections can be administered by the patients themselves or by their carers as long as they are properly trained. The patient or caregiver will also receive instructions on how to keep a treatment journal and what to do if serious side effects occur. For all the details, please refer to the summary of product characteristics (included with the EPAR).
How does Zutectra work?
The active substance in Zutectra, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood. Antibodies are naturally occurring proteins in the blood that help the body fight infections and other diseases. Zutectra prevents hepatitis B reinfection by keeping the levels of human hepatitis B immunoglobulins in the blood sufficiently high so that they can bind to the virus and stimulate the immune system to destroy it. Medicines given in a vein containing human specific hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
How has Zutectra been studied?
The applicant presented data on another medicinal product containing human hepatitis B immunoglobulins resulting from studies conducted in experimental models.
Zutectra has been studied in one main study involving 30 adults who have recently undergone liver transplantation. The main measure of effectiveness was the number of patients with an anti-hepatitis B immunoglobulin level in the blood above 100 IU per liter after 18 - 24 weeks. This level is considered sufficient for protection against re-infection with hepatitis B virus.
What benefit has Zutectra shown during the studies?
Zutectra was effective in maintaining the antibody level needed to protect against hepatitis B reinfection. All 23 patients who completed the treatment had antibody levels above 100 IU per liter.
What are the risks associated with Zutectrar?
The most common side effects with Zutectra (seen in more than 1 patient in 10) are pain, hives (itchy rash) and hematoma (blood under the skin) at the injection site. For the full list of all side effects reported with Zutectra, see the Package Leaflet.
Zutectra should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other substances or to human immunoglobulins. Zutectra should not be administered into a blood vessel.
Why has Zutectra been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zutectra's benefits are greater than its risks and recommended that Zutectra be given marketing authorization.
More information on Zutectra
On November 30, 2009, the European Commission issued a marketing authorization valid throughout the European Union to Biotest Pharma GmbH for Zutectra. The marketing authorization is valid for five years and can be renewed upon expiry.
For the full EPAR for Zutectra, click here.
Last update of this summary: 10-2009.
