"The Centers for Disease Control and Prevention has identified a cluster of newborns in Tennessee with late vitamin K deficiency bleeding (VKDB). VKDB is a serious, but preventable bleeding disorder that can cause bleeding in the brain. In each"...
- 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.
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