CEPROTIN® for short-term
prophylaxis
CEPROTIN® prevents serious thrombotic complications as a short-term prophylactic measure.1
CEPROTIN® TREATMENT WAS RATED AS EXCELLENT FOR SHORT-TERM PROPHYLAXIS
Study design:
A retrospective analysis of data on 22 subjects (11 male; 11 female; <1 year of age 15; >1 year of age 7) treated with CEPROTIN® under compassionate use provision in any open-label, multicentre study. Clinical efficacy was evaluated in terms of regression of any skin lesion present at entry, and the dissolution of thrombotic occlusions was evaluated descriptively. For the safety analysis, an additional 57 subjects receiving CEPROTIN® for other types of protein C deficiencies were included.
In an open-label, multicentre study of the efficacy of CEPROTIN® where short-term prophylaxis was evaluated descriptively, 11 of 12 cases rated treatment as excellent (1 case of short-term prophylaxis was rated good).2
Of investigators rated CEPROTIN® treatment courses for short-term prophylaxis as excellent or good (12 cases treated in 6 subjects).2
EMA approved indication:1
CEPROTIN® is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with Severe Congenital Protein C Deficiency. Furthermore CEPROTIN® is indicated for short-term prophylaxis in patients with Severe Congenital Protein C Deficiency if one or more of the following conditions are met: surgery or invasive therapy is imminent; while initiating coumarin therapy; when coumarin therapy alone is not sufficient; when coumarin therapy is not feasible.
During this study more than 7,500 CEPROTIN® infusions were administered. No adverse events considered related to
CEPROTIN® were recorded and no viral transmission or seroconversion was observed.
References:
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CEPROTIN. Summary of Product Characteristics (SmPC). EMA approved – last updated 09/2017.
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Moritz B, et al. Efficacy and safety of a high purity protein C concentrate in the management of patients with severe congenital Protein C deficiency. In: Scharrer I. & Schramm W., eds, 31st Hemophilia Symp (Hamburg 2000). 2002.101-109.