What is CEPROTIN?
CEPROTIN consists of a powder and a solvent which, when mixed, create a solution for injections. As an active ingredient it contains protein C of human origin.
What is CEPROTIN used for?
Protein C is a natural substance in the blood that controls coagulation. CEPROTIN is used in patients with severe congenital (hereditary) deficiency of protein C suffering from fulminant purpura (extensive coagulation of blood within the vessels resulting in death of tissues immediately underlying the skin, which often leads to organic insufficiency and amputation) and coumarin-induced skin necrosis (complication following a drug-based anticoagulant therapy such as warfarin that causes skin death). CEPROTIN is also used for the prevention of short-term coagulation in patients with severe congenital protein C deficiency in cases where there is a greater risk of coagulation, for example during surgery, or if coumarin therapy alone does not is sufficient or practicable.
The medicine can only be obtained with a prescription.
How is CEPROTIN used?
Treatment with CEPROTIN should be started under the supervision of a doctor experienced in this type of treatment in cases where it is possible to monitor the activity of the protein C. CEPROTIN is administered intravenously (injected into a vein) at an injection rate not greater than 2 ml per minute, but in children weighing less than 10 kg the injection rate should not exceed 0.2 ml per kilogram of body weight per minute.
How does CEPROTIN work?
CEPROTIN contains human protein C, extracted from human plasma (the liquid part of the blood) and purified. In the human body, protein C controls thrombin production, one of the substances (factors) involved in the coagulation process. Protein C slows thrombin production and, consequently, coagulation. An injection of CEPROTIN causes an immediate but temporary increase in protein C levels. Replacement of protein C in patients with protein C deficiency should control or avoid thrombus formation (clots).
What studies have been carried out on CEPROTIN?
CEPROTIN has been studied in a total of 79 patients; 22 of these had been diagnosed with the most severe forms of congenital protein C deficiency. The main factors measured in the study were the normalization of protein C levels and other indicators of coagulation activation. Skin lesions were also checked for improvements.
What benefit has CEPROTIN shown during the studies?
In patients with severe congenital protein C deficiency, CEPROTIN produced improvement in all 16 cases of fulminant purpura and in all six cases of coumarin-induced skin necrosis. The results obtained in the treatment of other coagulation disorders and in patients with other types of protein C deficiency are not sufficient to adequately assess the use of CEPROTIN in these groups.
What is the risk associated with CEPROTIN?
Some cases of allergic reaction have been observed. If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies can develop that inhibit the C protein. For the full list of all side effects reported with CEPROTIN, see the package leaflet.
CEPROTIN should not be used in patients who may be hypersensitive (allergic) to human protein C, mouse proteins or heparin, except in cases of life-threatening complications.
In patients starting treatment with other anticoagulants, such as warfarin, great care must be taken and therapy with CEPROTIN continued until complete adjustment of warfarin treatment.
Why has CEPROTIN been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that CEPROTIN's benefits are greater than its risks for the treatment of the severe form of congenital protein C deficiency and therefore recommended that CEPROTIN be given marketing authorization.
CEPROTIN was originally authorized in "exceptional circumstances", as it was currently not possible to obtain complete information on this medicine due to the small number of patients suffering from the disease. As the company provided the additional information requested, the "exceptional circumstances" ended on 28 July 2006.
Other information on CEPROTIN:
On 16 July 2001, the European Commission issued a marketing authorization for CEPROTIN to Baxter AG, valid throughout the European Union. The marketing authorization was renewed on 16 July 2006.
The full EPP for CEPROTIN can be found here.
Last update of this summary: 08-2007.
