Nilotaz
Nilotinib Capsules
Strength
✓150 mg✓200 mg
Pack Size
1 x 7
Drug Class
Antineoplastic agents, BCR-ABL tyrosine kinase inhibitors
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Nilotinib drug substance is supplied in the form of monohydrochloride monohydrate.
It is a white to slightly yellowish or slightly greenish-yellow powder.
Molecular formula
C28H22F3N7O•HCl•H2O
Molecular weight
584 g/mol
Corresponding nilotinib base molecular weight
529 g/mol
The solubility of nilotinib in aqueous solutions decreases with increasing pH.
Chemical name
4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide monohydrochloride monohydrate.
1. Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP: Indicated for treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase.
2. Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP: Indicated for treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia resistant or intolerant to prior therapy including imatinib.
3. Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP: Indicated for pediatric patients greater than or equal to 1 year of age with resistance or intolerance to prior tyrosine-kinase inhibitor therapy.
Nilotinib is used in treatment of blood cancer known as chronic myeloid leukemia.
It is used in patients whose disease could not be treated with other medications for leukemia or who cannot take these medicines because of side effects.
- Nilotinib prolongs the QT interval.
- Monitor:
- hypokalemia
- hypomagnesemia
- ECG changes
- ECGs should be obtained:
- at baseline
- seven days after initiation
- periodically thereafter
- after dose adjustments
- Sudden deaths have been reported in patients receiving nilotinib.
- Avoid use in patients with:
- hypokalemia
- hypomagnesemia
- long QT syndrome
- Avoid concomitant use with:
- drugs known to prolong QT interval
- strong CYP3A4 inhibitors
- Avoid food 2 hours before and 1 hour after taking the dose.
Dose nilotinib capsules twice daily at approximately 12-hour intervals on an empty stomach.
No food should be consumed
- At least 2 hours before dose
- At least 1 hour after dose
Capsules should be swallowed whole with water.
For patients unable to swallow capsules
- Contents may be dispersed in 1 teaspoon of applesauce.
- Mixture should be taken immediately within 15 minutes.
Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP:
- Recommended dosage is 300 mg orally twice daily.
Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP:
- Recommended dosage is 400 mg orally twice daily.