Characteristics of the medicinal product
Nonafact consists of a powder and a solvent to be mixed together to form an injectable solution (in the vein). Nonafact contains the human coagulation factor IX active ingredient, which promotes blood clotting.
Therapeutic indications
Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by factor IX deficiency). It can be used in adults and children over the age of 6 and is intended for short-term or long-term use.
The medicine can only be obtained with a prescription.
Method of use
Nonafact is administered by intravenous injection (into a vein) to a maximum of 2 ml per minute. The dose varies depending on whether Nonafact is used to treat bleeding or to prevent it during surgery. The dose should also be adjusted depending on the severity of the bleeding or the type of surgery. It is generally administered once a day, except in the case of life-threatening. All information on how to calculate the doses can be found in the package insert.
Mechanisms of action
Nonafact contains human blood coagulation factor IX, extracted and purified from human plasma (the liquid part of the blood). In the body, factor IX is one of the substances (factors) involved in blood coagulation. Haemophilia B is characterized by the lack of factor IX, which causes blood clotting problems, such as bleeding in joints, muscles or internal organs. Nonafact, used to replace the missing factor IX, removes the factor IX deficiency and temporarily controls bleeding disorders.
Studies carried out
Nonafact has been the subject of two clinical studies involving 26 patients who received Nonafact as a preventive treatment (eg before a large exercise) and 8 patients who received Nonafact during 11 surgeries. Most patients had severe hemophilia B. The studies evaluated the number of serious or life-threatening bleeding episodes detected during treatment, during or after surgery.
Benefits found following the studies
Nonafact was considered "good" or "excellent" in terms of preventing bleeding in patients with haemophilia B.
Associated risks
Patients with haemophilia B may develop antibodies (inhibitors) against factor IX. If this happens, Nonafact may not be effective. Sometimes, in patients treated with factor IX products, allergic reactions (hypersensitivity) have occurred. If this happens, Nonafact may not be effective. For the complete list of side effects detected with Nonafact, see the package leaflet.
Nonafact should not be used in people who may be hypersensitive (allergic) to human coagulation factor IX or other ingredients of the medicine or to mouse proteins.
Grounds for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that Nonafact's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B and therefore recommended that it be given marketing authorization. for this medicine.
Further information
On 3 July 2001, the European Commission issued a marketing authorization valid for Nonafact, valid throughout the European Union, to Sanquin, CLB, Products Division.
For the full version of the evaluation (EPAR) of Nonafact, click here.
Last update of this summary: March 2006
