What is Helixate NexGen?
Helixate NexGen consists of a powder and a solvent to be mixed together to obtain a solution for injection. Helixate NexGen contains the active substance octocog alfa (recombinant coagulation factor VIII).
What is Helixate NexGen used for?
Helixate NexGen is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by a factor VIII deficiency). Helixate NexGen is intended for short-term or long-term use.
The medicine can only be obtained with a prescription.
How is Helixate NexGen used?
Treatment with Helixate NexGen should be started under the supervision of a doctor experienced in treating haemophilia.
Helixate NexGen is given as an intravenous injection (into a vein) that lasts several minutes at a maximum rate of 2 ml per minute. The dose and frequency of injection vary depending on whether Helixate NexGen is used to treat bleeding or to prevent it during surgery. The dose should also be adjusted depending on the severity and location of the bleeding or the type of surgery. Helixate NexGen can also be administered as a continuous infusion (drip into a vein) for at least seven days in patients undergoing major surgery. All information on how to calculate the doses can be found in the package leaflet.
How does Helixate NexGen work?
The active substance in Helixate NexGen, octocog alfa, is a protein that affects blood clotting. In the body, factor VIII is one of the substances (factors) involved in blood coagulation. Haemophilia A is characterized by the lack of factor VIII, which causes blood clotting problems, such as bleeding in joints, muscles or internal organs. Helixate NexGen, used to replace the missing factor VIII, makes it possible to remedy the deficiency and temporarily control bleeding disorders. Octocog alfa is not extracted from human plasma, but is produced by a method known as "recombinant DNA technology": that is, it is obtained from a cell in which a gene (DNA) has been introduced which makes it capable of producing factor VIII of human coagulation.
How has Helixate NexGen been studied?
Helixate NexGen is similar to another medicine previously authorized in the European Union (EU) called Kogenate, but is prepared differently to prevent human proteins in the medicine. For this reason Helixate NexGen was compared with Kogenate to verify that the two drugs are equivalent.
Helixate NexGen administered as an intravenous injection has been studied in 66 patients previously treated with recombinant coagulation factor VIII and in 61 children who had not been treated previously. The main indicator of effectiveness in studies was the number of treatments needed to stop each case of new bleeding.
Helixate NexGen has also been studied as a continuous infusion in 15 patients with haemophilia A undergoing major surgery. The main indicator of effectiveness was the doctor's judgment on the ability to stop the bleeding.
What benefit has Helixate NexGen shown during the studies?
Overall, in 95% of previously treated patients, bleeding stopped after one or two intravenous injections of Helixate NexGen. In previously untreated patients, bleeding has stopped after one or two intravenous injections in about 90% of cases. In cases of administration as a continuous infusion, arrest of bleeding was judged "excellent" in all 15 patients.
What is the risk associated with Helixate NexGen?
Patients with haemophilia A may develop antibodies (inhibitors) against factor VIII. An antibody is a protein produced by the body in response to unknown agents within the body's natural defense system. If Helixate antibodies are developed, NexGen does not work properly. In studies with Helixate NexGen, this occurred in 14% of previously untreated patients and in 17% of children who had been treated for less than five days in the past. However, it was found in less than 0.2% of patients treated for more than 100 days. The most common side effects of Helixate NexGen (seen in between 1 and 10 patients in 100) are reactions at the infusion site and hypersensitivity reactions (allergy) of the skin type (itching, rash and irritation). For the full list of all side effects reported with Helixate NexGen, see the Package Leaflet.
Helixate NexGen should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor VIII, mouse or hamster proteins or other ingredients of the medicine.
Why has Helixate NexGen been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Helixate NexGen's benefits are greater than its risks for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) and recommended release of the marketing authorization for the medicinal product.
More information on Helixate NexGen:
On 4 August 2000, the European Commission issued a marketing authorization for Helixate NexGen, valid throughout the EU. The marketing authorization was renewed on 4 August 2005. The marketing authorization holder is Bayer Schering Pharma AG.
The full EPAR for Helixate NexGen can be found here.
Last update of this summary: 04-2009.
