Author: Biotest Pharma GmbH


Long information

What is it?

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.

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

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. Standard antiviral medicines to prevent hepatitis B re-infection can be used together with Zutectra. The medicine can only be obtained with a prescription.

How is it used?

Zutectra is given as an injection under the skin once a week. Patients weighing less than 75 kg should receive 500 IU once a week, which 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.
Zutectra treatment 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 given into a vein, to produce stable levels of the active substance in the blood. Patients must be monitored regularly during Zutectra treatment to check that the blood levels of the active substance remain high enough.
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).

How does it work?

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.
Medicines given into a vein containing specific human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.

How has it been studied?

The applicant presented data on another medicine that contains human hepatitis B immunoglobulins from studies in experimental models.
Zutectra has been studied in one main study involving 30 adults who had recently had liver transplants. 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.

What benefits has it shown during the studies?

Zutectra was effective at maintaining an antibody level required to protect against hepatitis B re-infection. All 23 of the patients who completed treatment had antibody levels above 100 IU per litre.

What is the risk associated?

The most common side effects with Zutectra (seen in more than 1 patient in 10) are pain, urticaria (itchy rash) and haematoma (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 ingredients or to human immunoglobulins. Zutectra must not be given into a blood vessel.

Why has it 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 authorisation.

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