Overview

Cevenfacta is a medicine used to treat bleeding episodes and to prevent bleeding in patients undergoing surgery. It is used in adults and adolescents aged 12 years or older with inherited haemophilia who have developed or are expected to develop inhibitors (antibodies) against coagulation factors VIII or IX (proteins involved in blood clotting), or who are unlikely to respond to treatment with these coagulation factors.

Cevenfacta contains the active substance eptacog beta (activated).

Cevenfacta can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in the treatment of haemophilia or bleeding disorders.

The medicine is given as an injection into a vein.

For the treatment of bleeding episodes, an initial dose should be given as soon as possible after the first sign of a bleed. For mild to moderate bleeds, patients can be given a starting dose of 225 microgram per kilogram body weight and, if the bleeding is not controlled after 9 hours, doses of 75 microgram per kilogram should be given every 3 hours until the bleed is controlled. Patients can also start on 75 micrograms per kilogram, repeated every 3 hours until control of the bleed. For severe bleeds, patients should be given 225 micrograms per kilogram and, if the bleeding is not controlled within 6 hours after the first dose, doses of 75 microgram per kilogram should be given every 2 hours until the bleed is controlled.

For the prevention of bleeding during surgical or other medical procedures, Cevenfacta is given before and during the procedure, and in some cases for several days after, with the dose depending on the type of surgery.

Patients or caregivers may be able to give Cevenfacta themselves after suitable training, but treatment at home should not exceed 24 hours without consulting the treating doctor.

For more information about using Cevenfacta, see the package leaflet or contact your doctor or pharmacist.

The active substance in Cevenfacta, eptacog beta, is produced from rabbit milk by recombinant DNA technology. It is almost identical to a human protein called coagulation factor VII and works in the same way. In the body, factor VII is involved in blood clotting by activating another clotting factor (called factor X), which then starts a series of steps to form a blood clot at the site of bleeding.

By activating factor X, Cevenfacta can control the bleed in people with haemophilia A or B who do not have, do not have enough, or have developed inhibitors against clotting factors VIII or IX.

The benefits of Cevenfacta were evaluated in a main study in adults and adolescents (over 12 years of age) with haemophilia A or B with inhibitors. In this study, Cevenfacta was not compared with another treatment.

Twenty-seven patients were given Cevenfacta after bleeding episodes, and in 81.0% (204 out of 252) of the episodes treated with a lower dose (75 microgram per kg of patient body weight) and 90.3% (195 out of 216) of the episodes treated with a higher dose (225 microgram per kg of patient body weight) the symptoms had largely been reduced or had completely disappeared 12 hours after the first injection.

In another study which investigated Cevenfacta in the prevention of uncontrolled bleeding during and after surgical procedures, 12 patients with haemophilia A or B received the medicine before, during and after surgery. Two days after surgery, control of postoperative blood loss was considered good or excellent in 81.8% (9 out of 12) of surgeries.

The most common side effects with Cevenfacta (which may affect more than 1 in 100 people) are injection site discomfort and haematoma (a collection of blood under the skin) as well as injection related reactions, an increase in body temperature, dizziness and headache.

Cevenfacta must not be used in people who are hypersensitive (allergic) to eptacog beta, to rabbits or rabbit proteins, or to any of the other ingredients.

For the full list of side effects and restrictions of Cevenfacta, see the package leaflet.

Available treatment options in patients with haemophilia with inhibitors are very limited. Treatment with Cevenfacta was effective in controlling bleeding episodes in patients aged 12 and older, and side effects were mild. The European Medicines Agency therefore decided that the benefits of Cevenfacta are greater than its risks and that it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cevenfacta have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cevenfacta are continuously monitored. Suspected side effects reported with Cevenfacta are carefully evaluated and any necessary action taken to protect patients.

Cevenfacta received a marketing authorisation valid throughout the EU on 15 July 2022.

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Product information

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19/05/2022

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Cevenfacta
Active substance
Eptacog beta (activated)
International non-proprietary name (INN) or common name
Eptacog beta (activated)
Therapeutic area (MeSH)
  • Hemophilia A
  • Hemophilia B
Anatomical therapeutic chemical (ATC) code
B02BD08

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

  • in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU));
  •  in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.

Authorisation details

EMA product number
EMEA/H/C/005655

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Marketing authorisation holder
Laboratoire Francais du Fractionnement et des Biotechnologies

Tour W
102 Terrasse Boieldieu
92800 Puteaux
FRANCE

Opinion adopted
19/05/2022
Marketing authorisation issued
15/07/2022

Assessment history

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