SPRYCEL Rx

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. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

Adult Dose for SPRYCEL:

Swallow whole. ≥18yrs: 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. Concomitant CYP3A4 inhibitors (see Interactions): consider reducing dose. Concomitant CYP3A4 inducers (see Interactions): consider increasing dose. See literature for dose adjustments with toxicity.

Children's Dose for SPRYCEL:

<18yrs: not recommended.

Pharmacological Class:

Tyrosine kinase inhibitor.

Warnings/Precautions:

History of QT prolongation. Proarrhythmic conditions. Cumulative high-dose anthracycline therapy. Monitor for signs/symptoms of cardiac dysfunction; treat appropriately if occur. Hypokalemia, hypomagnesemia; correct electrolyte imbalances before starting 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 weekly for the first 2 months, then monthly thereafter. Hepatic impairment. Pregnancy (Cat.D; use adequate contraception); nursing mothers: not recommended.

Interactions:

Avoid potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin, voriconazole), grapefruit juice. May be antagonized by CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, 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, sirolimus, tacrolimus, ergot alkaloids). Caution with concomitant anticoagulants or drugs that inhibit platelet function. Caution with anti-arrhythmics or other drugs that may lead to QT prolongation.

Adverse Reactions:

Myelosuppression (eg, severe thrombocytopenia, neutropenia, anemia), fluid retention (eg, ascites, edema, pleural and pericardial effusions), GI upset, headache, dyspnea, musculoskeletal pain, rash, fatigue, severe hemorrhage (eg, CNS, GI); QT prolongation; cardiac events (eg, cardiomyopathy, CHF, fatal MI, left ventricular dysfunction); PAH.

How Supplied:

Tabs 20mg, 50mg, 70mg—60
80mg, 100mg, 140mg—30