Monograph Details
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Neoplasms
> Kinase inhibitors
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SPRYCEL |
| Manufacturer |
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Bristol-Myers Squibb |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tyrosine kinase inhibitor. |
| Generic Name |
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Dasatinib 20mg, 50mg, 70mg; tabs. |
| Indications |
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Chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Swallow whole. ≥18yrs: Chronic phase CML: 100mg once daily. Accelerated phase CML, myeloid or lymphoid blast CML, Ph+ ALL: 70mg twice daily (in AM and PM). Doses of up to 100mg twice daily have been used. Concomitant CYP3A4 inhibitors (see Interactions): consider reducing dose. Concomitant CYP3A4 inducers (see Interactions): consider increasing dose. See literature for dose adjustments with toxicity. |
| Precautions |
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History of QT prolongation. Proarrhythmic conditions. Cumulative high-dose anthracycline therapy. Hypokalemia, hypomagnesemia; correct electrolyte imbalances before starting therapy. Monitor for pleural effusions. Obtain CBCs weekly for the first 2 months, then monthly thereafter. Hepatic impairment. Pregnancy (Cat.D; use adequate contraception); nursing mothers: not recommended. |
| Interactions |
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Avoid potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin). May be antagonized by CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital); St. John's wort: not recommended. Separate dosing of antacids by at least 2 hours; H2 blockers, proton pump inhibitors: not recommended. May potentiate drugs metabolized by CYP3A4 (eg, cyclosporine, fentanyl, pimozide, quinidine, ergot alkaloids). Caution with concomitant anticoagulants or drugs that inhibit platelet function. |
| Adverse Reactions |
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Fluid retention, GI upset, abdominal pain, bleeding events, pyrexia, pleural effusion, febrile neutropenia, pneumonia, thrombocytopenia, dyspnea, anemia, cardiac failure, QT prolongation, others. |
| How Supplied |
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Tabs—60 |
| Additional Resources |
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• Related Prescribing Note |
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