Kiovig is a solution for infusion (drip into a vein). It contains the active substance human normal 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?|
Kiovig is used in patients who need more antibodies in their blood to help fight infections and other diseases. It is used to treat the following conditions:
Primary immunodeficiency syndromes PID, when people are born with an inability to produce enough antibodies.
Hypogammaglobulinaemia low levels of antibodies in patients
with chronic lymphocytic leukaemia a cancer of a type of white blood cell and frequent bacterial infections after preventive treatment with antibiotics has failed
with multiple myeloma another cancer of a type of white blood cell and frequent bacterial infections, in whom vaccination against pneumococcal bacteria has failed
who have had haematopoietic blood stem cell transplantation when the patient receives stem cells from a matched donor to help restore the bone marrow.
Acquired immune deficiency syndrome AIDS in children who contracted HIV from birth and have frequent infections.
Kiovig is also used to treat certain immune system disorders:
Idiopathic thrombocytopenic purpura ITP, a condition where people do not have enough platelets in the blood
Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body
Kawasaki disease, which causes multiple inflammations of several organs in the body.
The medicine can only be obtained with a prescription.
Kiovig is given as an infusion into a vein by a doctor or nurse. The dose and frequency of infusions depend on the disease being treated and may need to be adjusted for patients depending on their response. Kiovig can be diluted before administration. For full details, see the summary of product characteristics (also part of the EPAR).
The active substance in Kiovig, 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. Kiovig 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.
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 Kiovig in patients.
In the first study, Kiovig was used to replace antibodies in 22 patients with PID who had very low or no levels of immunoglobulin. The main measure of effectiveness was the number of serious bacterial infections and the amount of antibiotic used.
The second study looked at using Kiovig for immunomodulation in 23 patients with ITP. The main measure of effectiveness was the increase in platelets.
In the first study, Kiovig was as effective as the standard treatment in preventing infections and reducing antibiotic use. In the second study, Kiovig was shown to be effective in increasing the platelet count.
The most common side effects with Kiovig (seen in more than 1 patient in 10) are headache and pyrexia (fever). 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 Kiovig before or for a long time. For the full list of all side effects reported with Kiovig, see the package leaflet.
Kiovig should not be used in people who may be hypersensitive (allergic) to human normal immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
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 haematopoietic stem cell transplantation, without the need for specific studies in these diseases.
Therefore, the CHMP concluded that Kiovig?s benefits are greater than its risks and recommended that Kiovig be given marketing authorisation.