"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease"...
Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe myelosuppression and bleeding. Since SPRYCEL is associated with severe myelosuppression, [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS], patients who ingested more than the recommended dosage should be closely monitored for myelosuppression and given appropriate supportive treatment.
Acute overdose in animals was associated with cardiotoxicity. Evidence of cardiotoxicity included ventricular necrosis and valvular/ventricular/atrial hemorrhage at single doses ≥ 100 mg/kg (600 mg/m²) in rodents. There was a tendency for increased systolic and diastolic blood pressure in monkeys at single doses ≥ 10 mg/kg (120 mg/m²).
Last reviewed on RxList: 7/1/2013
This monograph has been modified to include the generic and brand name in many instances.
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