Welcome to ceprotin.com

Shire plc. is a global leader in therapeutics for rare coagulation disorders and this website is a resource for patients and healthcare professionals seeking information about CEPROTIN [Protein C Concentrate (Human)], a human plasma-derived Protein C concentrate for use as replacement therapy in patients with life-threatening blood clotting complications related to severe congenital Protein C deficiency.

Currently, there are fewer than 20 known cases of severe congenital Protein C deficiency in the United States. FDA has granted CEPROTIN therapy orphan drug status.

Indications and Usage

CEPROTIN [Protein C Concentrate (Human)] is indicated for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. CEPROTIN is indicated as a replacement therapy for pediatric and adult patients.

Important Risk Information

CEPROTIN may contain traces of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. Discontinue administration if symptoms of hypersensitivity/allergic reactions occur.

CEPROTIN is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.

CEPROTIN contains trace amounts of heparin, which may lead to Heparin-induced Thrombocytopenia.

Patients on a low sodium diet or who have renal impairment should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg.

The most serious and common adverse reactions to CEPROTIN observed in clinical trials were hypersensitivity or allergic reaction (itching and rash) and lightheadedness.

The following adverse reactions have been identified during post approval use of CEPROTIN: hemothorax, hypotension, hyperhydrosis, fever and restlessness.

Please review the CEPROTIN Prescribing Information for full prescribing details.

You will need the free Adobe Reader to view PDF ( ) files on this page.
Get Adobe Reader.