Sprycel Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Sprycel Indications
Indications
Sprycel Dosage and Administration
Adult
Children
Sprycel Contraindications
Not Applicable
Sprycel Boxed Warnings
Not Applicable
Sprycel Warnings/Precautions
Warnings/Precautions
Risk of severe myelosuppression. 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). In children with Ph+ ALL on combination chemotherapy, obtain CBCs before starting each block of chemotherapy and as clinically indicated; do every 2 days until recovery during consolidation. Monitor for 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. 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. Monitor AST/ALT at baseline, monthly, or as needed during therapy. Hepatic impairment. Elderly. Embryo-fetal toxicity. Pregnancy: avoid. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 30 days after the last dose. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Sprycel Pharmacokinetics
Absorption
The maximum plasma concentrations (Cmax) of dasatinib are seen between 0.5 hours and 6 hours (Tmax) following oral administration.
A high-fat meal increased the mean AUC of dasatinib following a single dose of 100 mg by 14%.
Distribution
Apparent volume of distribution is 2505 L (CV% 93%).
Plasma protein bound: ~96% (dasatinib); 93% (active metabolite).
Elimination
Fecal (85%), renal (4%). Half-life: 3–5 hours.
Sprycel Interactions
Interactions
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit juice; see Adults. May be antagonized by strong CYP3A4 inducers (eg, rifampin), St. John's wort; see Adults. Separate dosing of antacids by at least 2hrs; H2 blockers, proton pump inhibitors: not recommended. Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants. Caution with antiarrhythmics or other drugs that may lead to QT prolongation. Hepatotoxicity with concomitant chemotherapy; monitor LFTs.
Sprycel Adverse Reactions
Adverse Reactions
Myelosuppression, fluid retention, diarrhea, headache, dyspnea, musculoskeletal pain, rash, fatigue, nausea, severe hemorrhage (eg, CNS, GI); QT prolongation, cardiac events, PAH, severe skin reactions, hepatotoxicity. Also in children: effects on bone growth and development (monitor).
Sprycel Clinical Trials
See Literature
Sprycel Note
Not Applicable
Sprycel Patient Counseling
See Literature