CEVENFACTA® (eptacog beta [activated])
The efficacy and tolerability of CEVENFACTA® for the treatment of bleeding in haemophilia patients with inhibitors was established in PERSEPT 1, a prospective, randomised, open-label, crossover study of two initial dose regimens in 27 (adult and adolescent [12 years to <65 years]) subjects with haemophilia A or B and inhibitors. The primary efficacy endpoint was the successful treatment of a bleeding episode at 12 hours after initial study drug administration and without rebleeding prior to 24 hours. Results demonstrated CEVENFACTA® to be:1
Flexible
Choice of regimens with 75 μg/kg or 225 μg/kg initial dose to meet individual patient needs for bleeding episodes
Fast-acting
Median time to attain a “good” or “excellent” assessment by the patient for a bleeding episode was 5.98 hours (75 μg/kg initial dose) and 3 hours (225 μg/kg initial dose)
Reliable
Successful treatment of 81.0% (75 μg/kg initial dose) and 90.3% (225 μg/kg initial dose) of bleeding episodes at 12 hours without rebleeding prior to 24 hours (primary endpoint)
Convenient
Median of one (225 μg/kg) or two (75 μg/kg) injections were required to treat a bleeding episode
Find out more about the PERSEPT 1 study and CEVENFACTA® here
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
CEVENFACTA® should be prescribed by physicians experienced in the treatment of haemophilia and/or bleeding disorders.
References
1. CEVENFACTA® Summary of Product Characteristics.
RESOURCES
Click on the below to access selected resources to support the appropriate use of CEVENFACTA®.
ABOUT US
LFB has been developing, manufacturing and marketing therapeutic proteins since 1994. In France, via our subsidiary LFB BIOMEDICAMENTS we have a statutory mandate to fractionate blood derived plasma or components collected by the national blood donor agency to meet national needs.
Building on this history, LFB is today a major supplier of both plasma-derived and recombinant proteins in Europe. With two major bioproduction sites in France (and a third under construction) producing plasma-derived products and two further sites producing recombinant products (in France and the USA), we are well positioned to further our mission to supply new treatment options to patients in three major therapeutic areas: immunology, haemostasis and intensive care.
Find out more about us here
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