This page is intended as reference information for the general public in Great Britain.
What is BeneFIX and what is it used for?
The active ingredient in BeneFIX is nonacog alfa. It is available as a vial of powder and pre-filled syringes of solvent that are mixed together to form a solution for injection.
BeneFIX is a clotting (coagulation) factor IX product that is produced by recombinant DNA technology.
People who are born with haemophilia B lack a protein called factor IX to control bleeding. The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot, controlling bleeding.
BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (congenital factor IX deficiency). It is intended for either short-term or long-term use. BeneFIX can be used for all age groups.
Treatment should be given under the supervision of a physician experienced in the treatment of haemophilia but patients or their carers can give injections, provided that they have been trained appropriately.
The medicine can only be obtained with a prescription.
The European Medicines Agency (EMA) is an agency of the European Union (EU). The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. See EMA guidance on BeneFIX.
Medicines in Northern Ireland fall under the remit of the European Medicines Agency (EMA) whilst medicines in Great Britain (England, Scotland and Wales) fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA) following the UK leaving the European Union. These agencies are responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies.
If you would like to see the Summary of Product Characteristics (SPC) or Patient Information Leaflet (PIL) for BeneFIX please follow these links:
BeneFIX (nonacog alfa)
BeneFIX (nonacog alfa)
Pfizer is unable to provide advice on personal medical matters. Please consult your doctor or other relevant health professional for specific, health-related advice and support.
If you get any side effects when taking this or any other medicine, talk to your doctor or other relevant health professional e.g. pharmacist, nurse. This includes any possible side effects not listed in the packaging leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search the Google Play or Apple App Store for MHRA Yellow Card. By reporting side effects, you can help provide more information on the safety of this medicine.