"The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one pr"...
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], monitor patients who ingest more than the recommended dosage closely for myelosuppression and give 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).
None.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2016
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