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Nilotinib capsules
Tasigna® |
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FDA Approval: |
October 2007 |
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Indication: |
Chronic myelogenous leukemia (chronic and accelerated phase Philadelphia
chromosome positive) |
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Pharmacology: |
Kinase inhibitor |
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Usual Dose: |
Adults: 400 mg orally twice a day |
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Contraindications: |
Hypokalemia Hypomagnesemia
Long QT syndrome |
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Warnings: |
Monitoring: CBC, ECG, electrolytes, lipase, liver function Avoid: Other
QT-prolonging drugs;potent CYP450 3A4 inhibitors or inducers; grapefruit; food
within 2 hours before or 1 hour after dose
Women should use effective contraception to avoid becoming pregnant
Use caution: hepatic impairment, history of pancreatitis
Sudden deaths have been reported
Should not be taken by patients with hereditary galactose intolerance, severe
lactase deficiency, glucose-galactose malabsorption
Safety and efficacy not established in pediatric patients
Lactation: Safety unknown; discontinue drug or discontinue breastfeeding |
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Pregnancy Category: |
D |
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Side Effects: |
Serious: QT prolongation, sudden death
Myelosuppression (most commly thrombocytopenia and neutropenia)
Serum lipase increases
Liver toxicity
Electrolyte abnormalities
Common:
Rash
Pruritus
Nausea
Fatigue
Headache
Constipation
Diarrhea
Vomiting
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Drug Interactions: |
CYP450 3A4 inhibitors CYP450 3A4 inducers
P-glycoprotein inhibitors |
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