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Active Substance: human coagulation factor IX
Common Name: human coagulation factor IX
ATC Code: B02BD04
Marketing Authorisation Holder: Sanquin
Active Substance: human coagulation factor IX
Status: Authorised
Authorisation Date: 2001-07-03
Therapeutic Area: Hemophilia B
Pharmacotherapeutic Group: Antihemorrhagics

Therapeutic Indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

What is Nonafact?

Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip into a vein). Nonafact contains the active ingredient human coagulation factor IX, which helps blood to clot.

What is Nonafact used for?

Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX). Nonafact can be used in adults and children over the age of 6. Nonafact is intended for either short-term or long-term use.

The medicine can only be obtained with a prescription.

How is Nonafact used?

Nonafact is given by intravenous infusion (into a vein) at no more than 2 ml per minute. The dose depends on whether Nonafact 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. It is generally administered once a day, except in life-threatening situations. The full detail on how to calculate the doses is included in the Package Leaflet.

How does Nonafact work?

Nonafact contains human 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 (clotting). Patients with haemophilia B lack factor IX, and this causes blood coagulation problems, such as bleeding in the joints, muscle or internal organs. Nonafact is used to replace the missing factor IX, it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.

How has Nonafact been studied?

Nonafact has been studied in two clinical studies, including 26 patients who received Nonafact as a prevention treatment (for example before extensive exercise), and 8 patients who received Nonafact during 11 surgical interventions. Most patients had severe haemophilia B. The studies assessed the number of major or life-threatening bleeding episodes that occurred during treatment, or during and after surgery.

What benefit has Nonafact shown during the studies?

Nonafact was rated as “good” or “excellent” in its ability to prevent bleeding in patients with haemophilia B.

What is the risk associated with Nonafact?

Haemophilia B patients may develop antibodies (inhibitors) to factor IX. If this happens Nonafact may not work effectively. Hypersensitivity (allergic reactions) has been sometimes seen in patients treated with factor IX-containing products. If this happens, Nonafact will not work effectively. For the full list of all the side effects reported with Nonafact, please see the Package Leaflet.

Nonafact should not be used in people who may be hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.

Why has Nonafact been approved?

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. They recommended that Nonafact be given marketing authorisation.

Other information about Nonafact

The European Commission granted a marketing authorisation valid throughout the European Union, for Nonafact to Sanquin, CLB, Products Division on 3 July 2001.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.