Generic Name and Formulations:
Dasatinib 20mg, 50mg, 70mg, 80mg, 100mg, 140mg; tabs.
Indications for SPRYCEL:
Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib in adults. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy in adults.
Swallow whole. Chronic phase CML: 100mg once daily. Doses of up to 140mg once daily have been used. Accelerated phase CML, myeloid or lymphoid blast CML, Ph+ ALL: 140mg once daily. Doses of up to 180mg once daily have been used. Continue until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors; if unavoidable, consider reducing Sprycel dose (see full labeling). Avoid concomitant strong CYP3A4 inducers; if unavoidable, consider increasing Sprycel dose (monitor). Dose adjustments for toxicity: see full labeling.
Swallow whole. Chronic phase CML: <10kg: not recommended. 10–<20kg: initially 40mg once daily; may increase to max 50mg/day. 20–<30kg: initially 60mg once daily; may increase to max 70mg/day. 30–<45kg: initially 70mg once daily; may increase to max 90mg/day. ≥45kg: initially 100mg once daily; may increase to max 120mg/day. Recalculate dose every 3 months based on changes in body weight. Continue until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors; if unavoidable, consider reducing Sprycel dose (see full labeling). Avoid concomitant strong CYP3A4 inducers; if unavoidable, consider increasing Sprycel dose (monitor). Dose adjustments for toxicity: see full labeling.
Monitor for signs/symptoms of cardiac dysfunction; treat appropriately if occur. Congenital long QT syndrome. Proarrhythmic conditions. Cumulative high-dose anthracycline therapy. Hypokalemia, hypomagnesemia; correct electrolyte imbalances before starting and during therapy. Monitor for pleural effusions. Increased risk of pulmonary arterial hypertension (PAH); evaluate for signs/symptoms of underlying cardiopulmonary disease before and during treatment; permanently discontinue if occurs. Obtain CBCs every 2 weeks for 12 weeks, then every 3 months thereafter (chronic phase CML) or weekly for the first 2 months, then monthly thereafter (advanced phase CML or Ph+ ALL). Permanently discontinue if severe skin reactions (eg, Stevens-Johnson syndrome) occur. Increased risk of tumor lysis syndrome in advanced stage disease and/or high tumor burden. Maintain adequate hydration. Correct uric acid levels before therapy and monitor electrolytes. Hepatic impairment. Elderly. Embryo-fetal toxicity. Pregnancy; avoid. Females of reproductive potential should use effective contraception during and for 30 days after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Tyrosine kinase inhibitor.
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit juice; see Adult. May be antagonized by strong CYP3A4 inducers (eg, rifampin), St. John's wort; see Adult. Separate dosing of antacids by at least 2hrs; H2 blockers, proton pump inhibitors: not recommended. Caution with concomitant anticoagulants or drugs that inhibit platelet function. Caution with antiarrhythmics or other drugs that may lead to QT prolongation.
Myelosuppression (eg, severe thrombocytopenia, neutropenia, anemia), fluid retention, diarrhea, headache, dyspnea, musculoskeletal pain, rash, fatigue, nausea, severe hemorrhage (eg, CNS, GI); QT prolongation, cardiac events, PAH, severe skin reactions. Also in children: effects on bone growth and development (monitor).
Tabs 20mg, 50mg, 70mg—60; 80mg, 100mg, 140mg—30