Shire Reports on Four Decades of Real-World Safety Experience With FEIBA® [Anti-Inhibitor Coagulant Complex] - Seite 3

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

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

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

For FEIBA Full Prescribing Information, visit http://www.shirecontent.com/PI/PDFs/FEIBA_USA_ENG.pdf  

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

FEIBA is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.

References 

1. WFH Inhibitors Working Group. "About Bleeding Disorders: What are inhibitors?" World Federation of Hemophilia website. http://www.wfh.org/en/page.aspx?pid=651 Accessed November 7, 2016.
2. Wight J. Paisley S. "The Epidemiology of Inhibitors in Haemophilia A: A Systematic Review." Haemophilia 2003.
3. Center for Disease Control and Prevention. "Inhibitors." CDC website. https://www.cdc.gov/ncbddd/hemophilia/inhibitors.html Accessed November 30, 2016.
4. Knappe S. et al. "Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk." American Society of Hematology. San Diego, California. December 3-6, 2016. Available at: http://www.bloodjournal.org/content/128/22/4952
5. FEIBA Prescribing Information.
6. Crea R. et al. "Four Decade Cumulative Review of Thrombo-Embolic Events Reported with the Use of Activated Prothrombin Complex Concentrate in Congenital Haemophilia." American Society of Hematology. San Diego, California. December 3-6, 2016. Available at: http://www.bloodjournal.org/content/128/22/503