Advate

What is Advate?

Advate consists of a powder and a solvent which are mixed to make a solution for injection. Advate contains the active substance octocog alfa (human coagulation factor VIII).

What is Advate used for?

Advate is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by a lack of factor VIII). Advate is intended for short-term or long-term use.
The medicine can only be obtained with a prescription.

How is Advate used?

Advate should be prescribed by a physician experienced in the treatment of haemophilia. Advate is administered intravenously (injection into a vein) at a maximum rate of 10 ml per minute. The dose and frequency vary depending on whether Advate is used to treat. bleeding or to prevent it during surgery. The dose should also be adjusted according to the severity of the bleeding or the type of surgery. All information on how to calculate doses can be found in the package leaflet.

How does Advate work?

Advate contains the active substance octocog alfa, which is a protein that causes blood to clot. In the body, factor VIII is one of the substances (factors) involved in blood clotting. Hemophilia A is characterized by a lack of factor VIII, which causes blood clotting problems, such as bleeding in the joints, muscles or in internal organs. Advate, used to replace the missing factor VIII, makes it possible to remedy the factor VIII deficiency and to temporarily control bleeding disorders.
Octocog alfa is not extracted from human plasma but is produced by a method known as "recombinant DNA technology": it is made by a cell that has received a gene (DNA), which makes it able to produce the human coagulation factor VIII.

How has Advate been studied?

Advate is similar to another medicine authorized in the European Union (EU) called Recombinate, but it is prepared differently so that it does not contain human or animal proteins. For this reason, in the main study carried out on Advate, it was compared with Recombinate. in 111 patients with haemophilia A to show that the two medicines are equivalent. The study also analyzed the number of bleeding episodes and evaluated the effectiveness of Advate in "stopping" bleeding on a scale ranging from "none" "to" excellent in 107 patients, all treated with Advate.
Three other studies looked at the use of the medicine in bleeding prevention and surgery in patients with severe or moderately severe haemophilia A; one of these studies involved 53 children under the age of six.

What benefit has Advate shown during the studies?

In the main study, the efficacy of Advate in preventing bleeding was rated "excellent" or "good" in 86% of 510 new bleeding episodes. However, 81% of these bleeding episodes required a single treatment with Advate.
The additional studies confirmed the effectiveness of Advate, including in children under the age of six.

What is the risk associated with Advate?

Patients with haemophilia A can develop antibodies (inhibitors) against factor VIII. An antibody is a protein that the body, within its natural defense system, produces in response to unknown agents. If antibodies develop, Advate does not work effectively. The most common side effects of Advate (seen in 1 to 10 patients in 100) are dizziness, headache, pyrexia (fever) and the presence of antibodies to factor VIII. Sometimes allergic (hypersensitivity) reactions have occurred in patients treated with factor VIII-containing medicines. For the full list of side effects reported with Advate, see the Package Leaflet.
Advate must not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, mouse or hamster proteins, or other ingredients of the medicine.

Why has Advate been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Advate's benefits are greater than its risks for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The committee recommended the granting of a marketing authorization for Advate.

Learn more about Advate

On 2 March 2004, the European Commission granted Baxter AG a "Marketing Authorization" for Advate, valid throughout the European Union. The "Marketing Authorization" was renewed on 2 March 2009.
For the full version of Advate's EPAR, click here.

Last update of this summary: 03-2009

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