Approved January 16, 2009

FIBRINOGEN CONCENTRATE (HUMAN)
(FDA Category Biologic)

RiaSTAP(TM) (CSL Behring) made from the plasma of healthy human blood donors, human fibrinogen (factor I) concentrate facilitates the coagulation process by replacing the missing, or low coagulation factor which acts as a substrate of 3 coagulation enzymes: thrombin, factor XIIIa, and plasmin to form fibrin.

DOSING INFORMATION: When the baseline fibrinogen level is known, the dose should be calculated using the target plasma fibrinogen levels based on the type of bleeding, actual measured plasma fibrinogen level, and body weight. Dose = (target level in milligrams/deciliter (mg/dL) - measured level (mg/dL)) divided by 1.7 (mg/dL per milligram/kilogram body weight). When the baseline fibrinogen level is unknown, the recommended dose is 70 mg/kg IV. Maintain the fibrinogen level at 100 mg/dL until hemostasis is obtained.

PHARMACOKINETICS: The mean half-life is 78.7 hours, and the mean clearance rate is 0.59 mL/hr/kg. The in-vivo recovery was a mean increase of 1.7 mg/dL (range 1.3 to 2.73 mg/dL) of fibrinogen plasma concentration per mg/kg of body weight (eg, dose of 70 mg/kg increased fibrinogen plasma concentration by approximately 120 mg/dL). In patients less than age 16 years, there was a shorter half-life (70 hours), and a faster clearance (0.73 mL/hr/kg).

CAUTIONS: Contraindicated in patients with previous severe immediate hypersensitivity reactions including anaphylaxis to human fibrinogen concentrate. Thromboembolic events can occur. There is a theoretical risk of infection since the product is made from human plasma. The most common adverse reactions include fever and headache.

FDA APPROVED INDICATIONS: Human fibrinogen human concentrate is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia), and is not indicated for dysfibrinogenemia.