"The European Commission has approved rFVIIIFc (Elocta, Swedish Orphan Biovitrum [Sobi] and Biogen) for the treatment of hemophilia A in all 28 European Union (EU) member states, Iceland, Liechtenstein, and Norway, according to a joint news"...
- Inform patients of the signs and symptoms of allergic hypersensitivity reactions, such as urticaria, rash, tightness of the chest, wheezing, hypotension and/or anaphylaxis experienced during or after injection of Kcentra [see WARNINGS AND PRECAUTIONS].
- Inform patients of signs and symptoms of thrombosis, such as limb or abdomen swelling and/or pain, chest pain or pressure, shortness of breath, loss of sensation or motor power, altered consciousness, vision, or speech [see WARNINGS AND PRECAUTIONS].
- Inform patients that, because Kcentra 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 [see WARNINGS AND PRECAUTIONS and DESCRIPTION
Last reviewed on RxList: 8/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kcentra Information
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