Data from FDA - Curated by Toby Galbraith - Last updated 21 April 2017
FDA (Food and Drug Administration, USA)
• 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).
• 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).
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).
• 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).
|Date First Approved||16-01-2009|
|Marketing authorisation holder||CSL Behring GmbH|