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FEIBA- anti-inhibitor coagulant complex kit

Patient Information

  1. Inform patients:
    • of the signs and symptoms of thrombosis, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain. Advise patients to seek immediate medical attention if any of these symptoms occur.
    • of the signs and symptoms of hypersensitivity reactions, such as urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment.
    • that because FEIBA is made from human blood, 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.
    • if they are on emicizumab prophylaxis therapy and need FEIBA to treat a breakthrough bleeding episode then they must be monitored by their hemophilia treating physician, preferably at the hemophilia treatment center (HTC)
    • to report any adverse reactions or problems following FEIBA administration to their hemophilia treating physician.

To enroll in the confidential, Industry-wide Patient Notification System, call 1-888-873-2838.

BAXALTAand FEIBAare trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

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

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

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