Details

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Manufacturer
NOVARTIS PHARMA STEIN AG(SWITZERLAND)

Registraction Number
MAL19106015ARZ

Content:

• Active Ingredient: 50 mg nilotinib base (as hydrochloride monohydrate)
• Inactive Ingredients: Lactose monohydrate, Crospovidone, Poloxamer, Silica colloidal, anhydrous/Colloidal silicon dioxide, Magnesium stearate
• Capsule Shell: Gelatin, Titanium dioxide (E 171), Iron oxide, red (E 172), Iron oxide, yellow (E 172)

Indications:

• Adult and Pediatric Patients: For newly diagnosed Ph+ CML in chronic phase.
• Adult Patients: For chronic phase and accelerated phase Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
• Pediatric Patients: For Ph+ CML-chronic phase and accelerated phase resistant or intolerant to prior tyrosine-kinase inhibitor therapy.

Instructions:

• Dosage: Typically, 300 mg orally twice daily for newly diagnosed Ph+ CML-chronic phase, and 400 mg orally twice daily for resistant or intolerant cases.
• Administration: Swallow the capsules whole with water. Avoid food 2 hours before and 1 hour after taking the dose3.
• Monitoring: Regular ECGs to monitor QTc interval, and periodic monitoring for hypokalemia or hypomagnesemia.