Bristol-Myers Squibb


Concise Prescribing Info
Adults w/ newly diagnosed chronic myeloid leukemia (CML) in chronic phase; chronic, accelerated or myeloid or lymphoid blast phase CML w/ resistance or intolerance to prior therapy including imatinib; Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) w/ resistance or intolerance to prior therapy including imatinib.
Dosage/Direction for Use
Chronic phase CML 100 mg once daily. Accelerated phase CML, myeloid or lymphoid blast phase CML or Ph+ ALL 140 mg once daily. May escalate dose to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML & Ph+ ALL) in patient who did not achieve a hematologic or cytogenetic response at the recommended starting dose.
May be taken with or without food: Swallow whole, do not crush/cut.
Special Precautions
Myelosuppression. Perform CBCs in patients w/ chronic phase CML every 2 wk for 12 wk, then every 3 mth thereafter; patients w/ advanced phase CML or Ph+ ALL, wkly for the 1st 2 mth & then mthly thereafter. May cause platelet dysfunction & hemorrhage. Patients taking anticoagulants or antiplatelets. Fluid retention. Promptly evaluate w/ chest X-ray or additional diagnostic imaging in patients who develop symptoms suggestive or pleural effusion or other fluid retention eg, new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough. Evaluate for signs & symptoms of underlying cardiopulmonary disease prior to initiation of therapy; common etiologies including pleural effusion, pulmonary edema, anemia or lung infiltration in patients who develop dyspnea & fatigue. QT prolongation, caution in patients w/ hypokalemia or hypomagnesemia, congenital long QT syndrome, concomitant antiarrhythmics or QT-prolonging drugs & cumulative high-dose anthracycline therapy. Patients w/ risk factors or history of cardiac disease. Discontinue in case of pulmonary arterial HTN (PAH); severe mucocutaneous reaction including Stevens-Johnson syndrome & erythema multiforme. Consider screening for HBV before initiation of therapy. Hepatic impairment. Women of childbearing potential should avoid becoming pregnant during treatment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain; peripheral edema, fatigue, pyrexia, face edema; skin rash; pleural effusion, dyspnea; headache; myelosuppression (including anemia, neutropenia, thrombocytopenia); muskuloskeletal pain; increased/decreased wt; infection (including bacterial, viral, fungal, non-specified); hemorrhage.
Drug Interactions
CYP3A4 inhibitors may increase plasma conc. CYP3A4 inducers, antacids, H2-antagonists/proton-pump inhibitors (eg, famotidine, omeprazole) may decrease plasma conc. May alter plasma conc of CYP3A4 substrates (eg, alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, ergot alkaloids).
ATC Classification
L01EA02 - dasatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Sprycel FC tab 20 mg
Sprycel FC tab 70 mg
Sprycel FC tab 50 mg
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