Shire Reports on Four Decades of Real-World Safety Experience With FEIBA® [Anti-Inhibitor Coagulant Complex] - Seite 2

Shire continually evaluates the safety profile of its products through ongoing safety surveillance. The risk of thromboembolic events (TEEs) is well characterized in the FEIBA label. FEIBA has a boxed warning for identified thromboembolic risk.^[5] Approximately three TEEs have been reported per 100,000 infusions based upon more than seven billion units (equivalent to about two million infusions) distributed over the past 40 years.^[6]

During ASH, Shire is presenting an update on its safety database describing the real-world experience with FEIBA. The global review of safety databases for AE reports of FEIBA received from 1975 through July 2016 showing the reporting rate of TEEs associated with FEIBA is comparable with previously reported data. (Four Decade Cumulative Review of Thrombo-Embolic Events Reported with the Use of Activated Prothrombin Complex Concentrate in Congenital Haemophilia, http://www.bloodjournal.org/content/128/22/503.)^[6]

Indications for FEIBA [Anti-Inhibitor Coagulant Complex] 

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

• Control and prevention of bleeding episodes
• Perioperative management
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex] 

WARNING: THROMBOEMBOLIC EVENTS 

• Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors. 
• Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. 

The use of FEIBA is contraindicated in patients with:

• Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system
• Disseminated intravascular coagulation (DIC)
• Acute thrombosis or embolism (including myocardial infarction)

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.