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TASIGNA
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

TASIGNA Rx

Generic Name and Formulations:
Nilotinib (as HCl monohydrate) 150mg, 200mg; caps; contains lactose.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for TASIGNA:

Newly diagnosed chronic phase (CP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults and children. Chronic and accelerated phase Ph+ CML in adults resistant or intolerant to prior imatinib. Chronic phase Ph+ CML in children resistant or intolerant to prior tyrosine-kinase inhibitor therapy.

Adult:

Take on an empty stomach. Swallow whole with water; if unable, may disperse capsule contents in 1 tsp of applesauce, then take immediately (within 15 mins). Newly diagnosed Ph+ CML: 300mg every 12hrs. Hepatic impairment (mild, moderate, severe): initially 200mg twice daily, followed by dose increase to 300mg twice daily if tolerated. Resistant or intolerant Ph+ CML: 400mg every 12hrs. Hepatic impairment (mild or moderate): initially 300mg twice daily, followed by dose increase to 400mg twice daily if tolerated; severe: initially 200mg twice daily, followed by sequential dose increase to 300mg twice daily, and then 400mg twice daily if tolerated. Concomitant strong CYP3A4 inhibitors (newly diagnosed): if unavoidable, reduce to 200mg once daily; (resistant or intolerant): if unavoidable, reduce to 300mg once daily; monitor for QT prolongation. May give concomitant hematopoietic growth factors, hydroxyurea, or anagrelide if clinically indicated. Dose modifications for QT prolongation, hematological and non-hematological toxicities, and criteria for treatment discontinuation and re-initiation: see full labeling.

Children:

<1yr: not established. Take on an empty stomach. Swallow whole with water; if unable, may disperse capsule contents in 1 tsp of applesauce, then take immediately (within 15 mins). ≥1yr: Newly diagnosed, resistant or intolerant Ph+ CML-CP: 230mg/m2 every 12hrs (round to the nearest 50mg); max 400mg/dose. Continue if clinically beneficial or until unacceptable toxicity. May give concomitant hematopoietic growth factors, hydroxyurea, or anagrelide if clinically indicated. Dose modifications for QT prolongation, hematological and non-hematological toxicities, and criteria for treatment discontinuation and re-initiation: see full labeling.

Contraindications:

Hypokalemia. Hypomagnesemia. Long QT syndrome.

Boxed Warning:

QT prolongation. Sudden deaths.

Warnings/Precautions:

QT prolongation, sudden deaths have been reported; correct electrolyte abnormalities prior to initiating; monitor periodically. Obtain ECGs at baseline, after 7 days, then periodically and after dose adjustments. Cardiovascular status should be evaluated; monitor cardiovascular risk factors and actively manage during therapy. Uncontrolled or significant CVD (eg, recent MI, CHF, unstable angina, significant bradycardia). History of pancreatitis. Monitor for myelosuppression; withhold or reduce dose if occurs; perform CBCs every 2 weeks for 1st 2 months then once monthly. Monitor serum lipase, liver function monthly or as clinically indicated. Monitor lipids and glucose periodically during first year, then yearly. Total gastrectomy (monitor frequently); consider dose increase or alternative therapy. Tumor lysis syndrome possible; maintain adequate hydration, correct uric acid levels prior to initiating therapy. Monitor for signs/symptoms of bleeding. Hereditary galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption: not recommended. Monitor BCR-ABL transcript levels in patients eligible for treatment discontinuation or those who re-initiate treatment due to loss of molecular response, using an FDA authorized test (see full labeling). Monitor growth and development in children. Hepatic impairment: reduce dose. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for at least 14 days after last dose. Nursing mothers: not recommended (during and for at least 14 days after last dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant food (for at least 2hrs before and 1hr after dose), antiarrhythmics, or other drugs that may prolong QT interval. Avoid strong CYP3A4 inhibitors (eg, ketoconazole), grapefruit, grapefruit juice; see Adults. Avoid strong CYP3A4 inducers (eg, rifampicin), St. John's wort. Concomitant proton pump inhibitors: not recommended. Administer H2-blockers at least 10hrs before or 2hrs after nilotinib dose. Separate dosing of antacids by at least 2hrs of nilotinib dose.

Adverse Reactions:

Nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, night sweats, myelosuppression (thrombocytopenia, neutropenia, anemia); QT prolongation, elevated serum lipase, electrolyte abnormalities (hypophosphatemia, hypo- and hyperkalemia, hypocalcemia, hyponatremia), hemorrhage, hepatotoxicity, cardiac and arterial vascular occlusive events, severe fluid retention (monitor).

Note:

Testing considerations: BCR-Abl t(9;22)

Generic Availability:

NO

How Supplied:

Caps 150mg, 200mg—28, 112

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