Zutectra | European Medicines Agency (2024)

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

Zutectra is a solution for injection. It is available as a prefilled syringe containing 500 international units (IU) of the active substance, human hepatitis-B immunoglobulin.

Zutectra is used in adults who have had a liver transplant because of liver failure that was caused by hepatitis B infection. Zutectra is used to prevent re-infection with the hepatitis B virus in patients without active infection (i.e. those who test negative for the presence of the hepatitis B protein (HBsAg) and for hepatitis B DNA (HBV-DNA)). The use of standard antiviral medicines to prevent hepatitis B re-infection should be considered together with Zutectra.

The medicine can only be obtained with a prescription.

Zutectra is given as an injection under the skin once a week or every 2 weeks. The recommended dose normally ranges from 500 IU to 1,000 IU, and exceptionally up to 1,500 IU. The dose is established based on the patient’s blood levels of antibodies against the hepatitis B virus.

Zutectra treatment starts at least one week after the liver transplant. Before starting Zutectra, the patient will need to receive medicines that contain the same active substance as in Zutectra, but given into a vein.

Zutectra injections can be given by the patients themselves or their caregiver once they have been trained appropriately. The patient or caregiver will also be trained on how to keep a treatment diary and what to do if severe side effects occur. For full details, see the summary of product characteristics (also part of the EPAR).

The active substance in Zutectra, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood. Antibodies are proteins naturally found in the blood that help the body to fight infections and other diseases. Zutectra prevents the patient from being re-infected with hepatitis B by keeping the blood levels of human hepatitis B immunoglobulins high enough, so that they can attach to the virus and stimulate the immune system to destroy it.

Zutectra has been studied in one main study involving 30 adults who had undergone liver transplants. Zutectra treatment was started at least three months after the liver transplant. The main measure of effectiveness was the number of patients who had a blood level of hepatitis B immunoglobulin above 100 IU per litre after 18 to 24 weeks. This level is considered adequate to protect against re-infection with the hepatitis B virus.

In another study in 49 patients, Zutectra was given at least one week (approximately 8-11 days) after the liver transplant. The main measure of effectiveness was the number of patients in whom treatment failed, defined as blood levels of hepatitis B immunoglobulins falling below 100 IU per litre or re-infection by hepatitis B virus during the 24 weeks of treatment.

Zutectra has been shown to be effective at maintaining antibody levels required to protect against hepatitis B re-infection.

In the first study, all 23 of the patients who completed treatment had antibody levels above 100 IU per litre. In the second study, all of the 49 patients had antibody levels above 100 IU per litre and none of them was re-infected during the 24 weeks of treatment.

The most common side effects with Zutectra (seen in between 1 and 10 patients in 100) are reactions at the injection site, such as pain, urticaria (itchy rash), haematoma (blood under the skin) and erythema (reddening of the skin). For the full list of all side effects reported with Zutectra, see the package leaflet.

Zutectra must not be used in people who are hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins. Zutectra must not be given into a blood vessel.

The CHMP decided that Zutectra’s benefits are greater than its risks and recommended that Zutectra be given marketing authorisation.

A risk management plan has been developed to ensure that Zutectra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zutectra, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the EU for Zutectra on 30 November 2009.

For more information about treatment with Zutectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Zutectra : EPAR - Summary for the public

Adopted

English (EN) (75.18 KB - PDF)

First published: 12/02/2010Last updated: 23/02/2016

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Product information

Zutectra : EPAR - Product Information

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First published: 12/02/2010Last updated: 13/02/2024

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Latest procedure affecting product information: N/0064

12/02/2024

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

summary of product characteristics(annex I);
manufacturing authorisationholder responsible for batch release (annex IIA);
conditions of themarketing authorisation(annex IIB);
labelling(annex IIIA);
package leaflet(annex IIIB).

Zutectra : EPAR - All Authorised presentations

English (EN) (22.06 KB - PDF)

First published: 12/02/2010Last updated: 12/02/2010

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Product details

Name of medicine

Zutectra

Active substance

human hepatitis B immunoglobulin

International non-proprietary name (INN) or common name

human hepatitis B immunoglobulin

Therapeutic area (MeSH)

Immunization, Passive
Hepatitis B
Liver Transplantation

Anatomical therapeutic chemical (ATC) code

J06BB04

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

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.

Authorisation details

EMA product number: EMEA/H/C/001089
Marketing authorisation holder: Biotest Pharma GmbH
Landsteinerstrasse 5
D-63303 Dreieich
Germany
Marketing authorisation issued: 30/11/2009
Revision: 17

Assessment history

Zutectra : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (175.74 KB - PDF)

First published: 07/08/2010Last updated: 13/02/2024

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Zutectra-H-C-1089-II-0024 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/842266/2015

English (EN) (1.64 MB - PDF)

First published: 23/02/2016Last updated: 23/02/2016

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CHMP post-authorisation summary of positive opinion for Zutectra

AdoptedReference Number: EMA/CHMP/729343/2015

English (EN) (67.91 KB - PDF)

First published: 20/11/2015Last updated: 20/11/2015

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Zutectra : EPAR - Public assessment report

Adopted

English (EN) (420.86 KB - PDF)

First published: 12/02/2010Last updated: 12/02/2010

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Committee for Medicinal Products for Human use Summary of positive opinion for Zutectra

AdoptedReference Number: EMEA/CHMP/603846/2009

English (EN) (32.43 KB - PDF)

First published: 24/09/2009Last updated: 24/09/2009

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News on Zutectra

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015

20/11/2015

Topics

Medicines

This page was last updated on 13/02/2024