"To address "continuing safety concerns" about severe neutropenia associated with the atypical antipsychotic clozapine (multiple brands), the US Food and Drug Administration (FDA) is making changes to requirements for monitoring, prescribing, disp"...
- 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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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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