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 had a liver transplant following liver failure caused by hepatitis B infection. Zutectra is used to prevent reinfection with the hepatitis B virus. prevent hepatitis B reinfection.
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 should be given 500 IU once a week. The dose can be increased up to a maximum of 1 000 IU. Patients who weigh 75 kg or more should be given 1 000 IU once a week.
Treatment with Zutectra starts at least six months after the liver transplant. Before starting Zutectra, the patient will need to receive medicines that contain the same active substance as Zutectra, but administered into a vein, to produce stable levels of the active substance in the blood. Patients should be monitored regularly during treatment with Zutectra to ensure that the levels of the active substance in their blood remain sufficiently high.
Zutectra injections can be administered by the patients themselves or by their caregivers as long as they are properly trained. The patient or caregiver will also be instructed on how to keep a treatment diary and what to do if serious side effects occur. For full details, see the Summary of Product Characteristics (included in 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 human hepatitis B immunoglobulin levels high enough in the blood so that they can bind to the virus. and stimulate the immune system to destroy it. Medicines administered into a vein containing specific human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
How has Zutectra been studied?
The applicant submitted data on another medicinal product containing human hepatitis B immunoglobulins from studies conducted in experimental models.
Zutectra has been studied in one main study involving 30 adults who had recently undergone liver transplantation. The main measure of effectiveness was the number of patients with an anti-hepatitis B immunoglobulin level in their blood above 100 IU per liter after 18 to 24 weeks. This level is considered sufficient for protection against hepatitis B virus reinfection.
What benefit has Zutectra shown during the studies?
Zutectra was shown to be effective in maintaining the antibody level needed to protect against hepatitis B reinfection. All 23 patients who completed 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 in 10 patients) are pain, hives (itchy rash) and hematoma (blood under the skin) at the injection site. For the complete list of side effects reported with Zutectra, see the package leaflet.
Zutectra must 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 must not be given 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 a Marketing Authorization.
Learn more about Zutectra
On 30 November 2009, the European Commission granted Biotest Pharma GmbH a "Marketing Authorization" for Zutectra, valid throughout the European Union. The "Marketing Authorization" is valid for five years and can be renewed at expiration.
For the full version of Zutectra's EPAR, click here.
Last update of this summary: 10-2009.
Information about Zutectra published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
