Data from FDA - Curated by Toby Galbraith - Last updated 21 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

RiaSTAP, Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia (1).

RiaSTAP is not indicated for dysfibrinogenemia.

Full Prescribing information

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Advisory information

contraindications
• Anaphylactic or severe reactions to RiaSTAP or its components (4).
Special warnings and precautions

• Monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, discontinue administration and institute appropriate treatment (5.1).
• Thrombotic events have been reported in patients receiving RiaSTAP. Weigh the benefits of administration versus the risks of thrombosis (5.2)
• RiaSTAP is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent (5.3).

Adverse reactions

• The most serious adverse reactions observed are thrombotic episodes (pulmonary embolism, myocardial infarction, deep vein thrombosis) and anaphylactic reactions. The most common adverse reactions observed in clinical studies (frequency >1%) were fever and headache (6).

Usage information

Dosing and administration
For intravenous use only. Reconstitute prior to use.
Should be administered under the supervision of a physician.
• Dose (mg/kg body weight) = [Target level (mg/dL) - measured level (mg/dL)] / [1.7 (mg/dL per mg/kg body weight)]
• Dose when fibrinogen level is unknown: 70 mg/kg body weight (2.1).
• Monitoring of patient’s fibrinogen level is recommended during treatment. A target fibrinogen level of 100 mg/dL should be maintained until hemostasis is obtained.
• The injection rate should not exceed 5 mL per minute (2.3).
Use in special populations

• Pregnancy: No human or animal data. Use only if clearly needed (8.1).
• Pediatric: Shorter half life and faster clearance than in adults has been observed. These results are difficult to interpret because of the limited number of subjects (n=4)(8.4).

More information

Category Value
Authorisation number BLA125317
Orphan designation No
Product NDC 63833-891
Date First Approved 16-01-2009
Marketing authorisation holder CSL Behring GmbH

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