What is Privigen?
Privigen is a solution for infusion (drip into a vein). Privigen contains the active substance human normal immunoglobulin.
What is Privigen used for?
Privigen is used in three main patient groups:
- patients at risk of infection because they do not have enough antibodies (naturally occurring proteins in the blood that help the body fight infections and other diseases). These patients have congenital antibody deficiency (primary immunodeficiency syndrome, PID) as well as patients with whom the antibody deficiency is due to blood cancer (myeloma or chronic lymphoid leukemia) or children with acquired immunodeficiency syndrome (AIDS), prone to frequent infections. These conditions are called immunodeficiency syndromes and the indicated treatment is replacement therapy;
- patients with certain immune system disorders. These patients have an abnormality of the immune system (the defense system of the human body) that needs to be resolved. These may be patients with idiopathic thrombocytopenic purpura (ITP) with an insufficient number of platelets (components of the blood that promote clotting) and who are at high risk of bleeding and patients with certain diseases (Guillain Barré syndrome, Kawasaki disease ); this type of treatment is called immunomodulation (immune regulation);
- bone marrow transplant patients.
The medicine can only be obtained with a prescription.
How is Privigen used?
Privigen is given by intravenous infusion, usually by a doctor or nurse. The dose and frequency of infusions (how often they are given) depend on the disease being treated. In replacement therapy, the dose may need to be adjusted according to the patient's response. For complete information, please refer to the Summary of Product Characteristics included in the EPAR.
How does Privigen work?
The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (a component of blood). Basically, it contains immunoglobulin G (IgG), which is a type of antibody. IgG is used. in medicine since the 1980s and has a broad spectrum of activity against infectious organisms. Privigen helps restore abnormally low IgG levels in the blood to normal levels. At higher doses, it can help regulate an abnormal immune system and modulate the immune response.
How has Privigen been studied?
As human normal immunoglobulin has long been used to treat the indicated diseases, only two minor studies were needed to confirm the efficacy and safety of Privigen for patients according to current guidelines.
In the first study, Privigen was used as replacement therapy in 80 patients with PID, given at three to four week intervals. The main measure of effectiveness was the number of serious bacterial infections over a year of treatment.
The second study looked at the use of Privigen for immunomodulation in 57 subjects with ITP. Privigen was administered for two consecutive days. The main measure of effectiveness was the maximum number of platelets obtained during the week following the administration of Privigen.
In neither of the two studies was Privigen compared with other treatments.
What benefit has Privigen shown during the studies?
In the first study, patients had an average of 0.08 severe infections in one year. Since this value is below the predefined threshold of one infection per year, this indicates the effectiveness of the medicine in replacement therapy.
In the second study, 46 (81%) of the 57 patients had a platelet count greater than 50 million platelets per milliliter 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 of Privigen (seen in more than 1 in 10 patients) is headache. Some side effects are more likely to occur if infused at a high rate, in patients with low immunoglobulin levels or in patients treated with Privigen for the first time or a long time after the last administration. For the full list of side effects reported with Privigen, see the package leaflet.
Privigen should not be used in people who may be allergic to human normal immunoglobulin or any other ingredient or in patients who are allergic to other types of immunoglobulins, particularly if they have immunoglobulin A (IgA) deficiency and have anti-IgA antibodies. Privigen must not be given to patients with hyperprolinemia (a genetic dysfunction causing high levels of the amino acid proline in the blood).
Why has Privigen been approved?
Under current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be authorized for the treatment of all types of primary immunodeficiency as well as cases of antibody deficiency due to blood and cancer. of AIDS in children. They may also be authorized, without the need for specific studies, for the treatment of patients with Guillain Barré syndrome, patients with Kawasaki disease and patients about to undergo bone marrow transplantation.
Therefore, the Committee for Medicinal Products for Human Use (CHMP) concluded that Privigen's benefits are greater than its associated risks for patients requiring IgG for replacement therapy, immunomodulation or bone marrow transplantation, and recommended that it be released. of the authorization to place the product on the market. The committee recommended the granting of a marketing authorization for Privigen.
More information about Privigen
On April 25, 2008, the European Commission granted CSL Behring GmbH a "Marketing Authorization" for Privigen, valid throughout the European Union.
For the full version of the EPAR for Privigen, click here.
Last update of this summary: 03-2008.
The information on Privigen - human normal immunoglobulin 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.
