Privigen

human normal immunoglobulin

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 their 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 of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Privigen?

Privigen is a solution for infusion (drip into a vein). It contains the active substance human normal immunoglobulin.

What is Privigen used for?

Privigen is used in three main groups of patients:

• Patients who are at risk of infection because they do not have sufficient antibodies (proteins naturally found in the blood that help the body to fight infections and other diseases). These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID). It also includes patients whose lack of antibodies is due to a cancer of the blood (myeloma or chronic lymphoid leukaemia) or children born with acquired immune deficiency syndrome (AIDS), who suffer from frequent infections. These types of conditions are called ‘immunodeficiency syndromes’ and their treatment is called ‘replacement therapy’.
• Patients with certain immune disorders. These patients have an abnormal immune system (the body’s defence system) that needs to be adjusted. They include patients with idiopathic thrombocytopenic purpura (ITP) who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding, and patients with certain diseases (Guillain-Barré syndrome or Kawasaki disease). This type of treatment is called ‘immunomodulation’ (immune adjustment).
• Patients who have had a bone marrow transplant.

The medicine can only be obtained with a prescription.

How is Privigen used?

Privigen is usually given as an intravenous infusion by a doctor or nurse. The dose and frequency of infusions (how often it is given) depend on the disease being treated. In replacement therapy, the dose may need to be adjusted for patients depending on their response. For full details, see the Summary of Product Characteristics (also part of the EPAR).

How does Privigen work?

The active substance in Privigen, 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. Privigen works by restoring abnormally low IgG levels to their normal range in the blood. At higher doses, it can help to adjust an abnormal immune system and modulate the immune response.

How has Privigen been studied?

As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, only two small studies were needed to establish the effectiveness and safety of Privigen in patients.

In the first study, Privigen was used as replacement therapy in 80 patients with PID, with the medicine being infused every three or four weeks. The main measure of effectiveness was the number of serious bacterial infections over a year’s treatment.

The second study looked at using Privigen for immunomodulation in 57 patients with ITP. Privigen was given on two consecutive days. The main measure of effectiveness was the highest blood platelet level that was achieved in the week after Privigen was given.

Privigen was not compared to any other treatment in either study.

What benefit has Privigen shown during the studies?

In the first study, the patients had an average of 0.08 serious infections per year. Since this is below the predefined threshold of one infection per year, this indicates that the medicine is effective as replacement therapy.

In the second study, 46 (81%) of the 57 patients had a platelet count above 50 million platelets per millilitre at least once during the study. This confirmed that Privigen is effective in immunomodulation.

What is the risk associated with Privigen?

The most common side effect with Privigen (seen in more than 1 patient in 10) is headache. Some side effects are more likely to occur when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Privigen before or for a long time. For the full list of all side effects reported with Privigen, see the Package Leaflet.

Privigen should not be used in people who may be allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA. Privigen must not be used in patients with hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).

Why has Privigen been approved?

According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children. They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing a bone marrow transplant, without the need for specific studies in these diseases.

Therefore, the Committee for Medicinal Products for Human Use (CHMP) concluded that Privigen’s benefits are greater than its risks for patients who require IgG for replacement therapy, for immunomodulation or because of bone marrow transplantation. The Committee recommended that Privigen be given marketing authorisation.

Other information about Privigen

The European Commission granted a marketing authorisation valid throughout the European Union for Privigen to CSL Behring GmbH on 25 April 2008.

This EPAR was last updated on 17/04/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

19/03/2012  Privigen -EMEA/H/C/000831 -II/0058

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Replacement therapy in Primary immunodeficiency (PID) syndromes such as:

• congenital agammaglobulinaemia and hypogammaglobulinaemia
• common variable immunodeficiency
• severe combined immunodeficiency
• Wiskott Aldrich syndrome
• Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
• Children with congenital AIDS and recurrent infections.

Immunomodulation

• Immune thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.
• Guillain-Barré syndrome.
• Kawasaki disease.

Allogeneic bone marrow transplantation

Changes since initial authorisation of medicine

Initial marketing-authorisation documents