Kiovig - normal human immunoglobulin

What is Kiovig?

Kiovig is a solution to be administered by infusion (drip into a vein). Kiovig contains the active substance human normal immunoglobulin.

What is Kiovig used for?

Kiovig is used in three main groups of patients:

Patients at risk of infection because they do not have enough antibodies (proteins naturally present in the blood that help the body fight infections and other diseases). These patients may be individuals with congenital antibody deficiency (primary immunodeficiency syndrome - PID). It also includes individuals whose antibody deficiency is due to a blood tumor (myeloma or chronic lymphoid leukemia) or children born with acquired immunodeficiency syndrome (AIDS) and subject to frequent infections. These conditions are called "immunodeficiency syndromes" and treatment is referred to as "substitution therapy".
Patients with certain immune diseases. These patients have an abnormality of the immune system (the defense system of the human body must be regulated). They include patients with idiomatic thrombocytopenic purpura (ITP) who do not have enough platelets (blood components that contribute to coagulation) and who are at high risk of bleeding or patients with certain specific diseases (Guillain-Barré syndrome or Kawasaki disease) . This type of treatment is called "immunomodulation" (immune regulation).
Patients who have had a bone marrow transplant.

The medicine can only be obtained with a prescription.

How is Kiovig used?

Kiovig is usually given by a doctor or nurse as an intravenous infusion. The dose and frequency of infusions depend on the disease being treated. In replacement therapy the dose may be adjusted based on the patient's response. Kiovig can be diluted before use. For more details read the summary of product characteristics (also included with the EPAR).

How does Kiovig work?

The active substance in Kiovig, a normal human immunoglobulin, is a highly purified protein extracted from human plasma (a component of blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used in medicine since the 1980s and has a broad spectrum of activity against organisms that can cause infection. Kiovig helps to restore abnormally low IgG levels in the blood to normal levels. In higher doses, Kiovig can help regulate an immune system affected by abnormalities and modulate the immune response.

What studies have been carried out on Kiovig?

Human immuniglobulin has been used for some time to treat these diseases and according to current guidelines only two small studies were needed to establish the efficacy and safety of Kiovig in patients.

In the first study, Kiovig was used as a replacement therapy in patients with PID with very low or zero immunoglobulin levels (22 patients). The main measure of effectiveness was the number of serious bacterial infections and the amount of antibiotics used.

The second study examined the use of Kiovig for immunomodulation in 23 subjects with ITP. The main measure of effectiveness was the increase in platelets.

What benefit has Kiovig shown during the studies?

In the first study, Kiovig proved to be as efficient as standard treatment in preventing infections and reducing antibiotic use. In the second study, Kiovig was effective in increasing the platelet count.

What is the risk associated with Kiovig?

The most common side effects seen with Kiovig are headache and fever (more than 1 in 10 patients). Occasionally there are side effects that occur when a high rate of infusion is used, in patients with low immunoglobulin levels, or in patients who have never been given Kiovig 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 normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, particularly when they have a deficiency (very low levels) of immunoglobulin A ( IgA) and possess antibodies against IgA.

Why has Kiovig been approved?

According to current directives, medicines that have been shown to be effective in patients with PID and in ITP patients, can be approved to treat all types of primary immunodeficiency as well as low levels of antibodies due to blood cancer and AIDS in children . They can also be approved for the treatment of patients with Guillain-Barré syndrome, Kawasaki disease and patients whose bone marrow needs to be transplanted, without the need for specific studies for these diseases.

Therefore, the Committee for Medicinal Products for Human Use (CHMP) concludes that the benefits of Kiovig outweigh the risks for patients for whom IgG is required for replacement therapy, immunomodulation or bone marrow transplantation. The committee recommended that Kiovig be given marketing authorization.