ADVATE 250 IU powder and solvent for solution for injection

ATC Code
B02BD02
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About this drug

Admission country
Manufacturer Baxter AG
Narcotic drug No
Psychotropic No
Anatomical group Blut und blutbildende organe
Therapeutic group Antihämorrhagika
Pharmacological group Vitamin k und andere hämostatika
Chemical group Blutgerinnungsfaktoren
Substance Blutgerinnungsfaktor viii

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All to know

Author

Baxter AG

What is it?

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

What is it used for?

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

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How is it used?

Advate should be started by a doctor who has experience in the treatment of haemophilia. Advate is given by injection into a vein at a rate of up to 10 ml per minute. The dose and frequency depend on whether Advate is used to treat haemorrhage (bleeding) or to prevent it during surgery. The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery. Full details on how to calculate the doses are included in the Package Leaflet.

How does it work?

The active substance in Advate, octocog alfa, is a blood coagulation factor protein. In the body, factor VIII is one of the substances (factors) involved in blood coagulation (clotting). Patients with haemophilia A lack factor VIII, and this causes blood coagulation problems, such as bleeding in the joints, muscles or internal organs. Advate is used to replace the missing factor VIII. It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
Octocog alfa is not extracted from human plasma but 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 human coagulation factor VIII.

How has it been studied?

Advate is similar to another medicine approved in the European Union (EU) called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine. Because of this, the main study done with Advate compared it with Recombinate in 111 patients with haemophilia A to show that the two medicines are equivalent. The study went on to look at the number of bleeding episodes and rated Advate?s effectiveness in stopping bleeding on a scale from ?none? to ?excellent? in 107 patients, all of whom received Advate.
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of six years.

What benefits has it shown during the studies?

In the main study, the effectiveness of Advate in the prevention of bleeding was rated as ?excellent? or ?good? in 86% of the 510 new bleeding episodes. In addition, 81% of these bleeding episodes required only a single treatment with Advate.
The additional studies confirmed Advate?s effectiveness, including in children under six years of age.

What is the risk associated?

Haemophilia A patients may develop antibodies (inhibitors) to factor VIII. An antibody is a protein produced by the body in reaction to unknown agents as part of the natural defence system of the body. If antibodies develop, Advate will not work effectively. The most common side effects with Advate (seen in between 1 to 10 patients in 100) are dizziness, headache, pyrexia (fever) and the presence of antibodies against factor VIII. Hypersensitivity (allergic reactions) has sometimes been seen in patients treated with factor VIII-containing products. For the full list of all side effects reported with Advate, see the Package Leaflet.
Advate should not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.

Why has it 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 that Advate be given marketing authorisation.

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