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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/45410/2016

EMEA/H/C/002127

EPAR summary for the public

Hizentra

human normal immunoglobulin (SCIg)

This is a summary of the European public assessment report (EPAR) for Hizentra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Hizentra.

What is Hizentra?

Hizentra is a solution for injection under the skin. It contains the active substance human normal immunoglobulin (200 mg/ml).

What is Hizentra used for?

Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins. It is used to treat the following conditions:

•    primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);

•    low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections.

The medicine can only be obtained with a prescription.

How is Hizentra used?

Treatment with Hizentra should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems, but patients (or their carers) may administer it themselves once they have been trained and initially monitored. Hizentra is given as a subcutaneous infusion (very

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slow injection under the skin) in an area such as the abdomen (belly), thigh, upper arm or hip. The injection is normally given on a weekly basis, to provide a total monthly dose of around 2 to 4 ml per kg body weight, but the dose and frequency of injection may be adjusted according to the patient's response. At the start of treatment the doctor may decide to give an initial loading dose of 1 to 2.5 ml/kg.

How does Hizentra work?

The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. Hizentra works by restoring abnormally low IgG levels to their normal range in the patient's blood.

How has Hizentra been studied?

As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, Hizentra was investigated in one main study involving 51 PID patients who had already received human immunoglobulin treatment for at least six months. The patients received Hizentra every week for 28 weeks. The main measure of effectiveness was how the lowest IgG levels (called 'trough levels') seen during Hizentra treatment compared with the lowest levels seen during previous immunoglobulin treatment.

What benefit has Hizentra shown during the studies?

The lowest IgG levels seen during treatment with Hizentra (average trough level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.

What is the risk associated with Hizentra?

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain may occur occasionally. For the full list of all side effects reported with Hizentra, see the package leaflet.

Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood). It must not be injected into a blood vessel such as a vein or an artery. For the full list of restrictions, see the package leaflet.

Why has Hizentra been approved?

The CHMP noted that Hizentra can prevent serious bacterial infections in PID patients through weekly injections which may be given at home, while the side effects are not frequent or severe. It decided that Hizentra's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Hizentra?

A risk management plan has been developed to ensure that Hizentra is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and

Hizentra

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the package leaflet for Hizentra, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Hizentra

The European Commission granted a marketing authorisation valid throughout the European Union for Hizentra on 14 April 2011.

The full EPAR for Hizentra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Hizentra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2016.

Hizentra

EMA/45410/2016