Adult Dosing
Newly diagnosed Ph+ CML-CP
Resistant or intolerant Ph+ CML-CP and CML-AP
Notes- To be taken 1 hr before food or 2 hrs after food
- See prescribing information for details about dose adjustments based on toxicity
- Refer package insert for dose adjustments and modifications
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment
- Renal Impairment: Dose adjustments not defined
Hepatic Dose Adjustment
- Newly diagnosed Ph+ CML
- Child Pughs A/B/C: 200 mg PO bid, if tolerated increase dose to 300 mg PO bid
- Resistant or intolerant Ph+ CML
- Child Pughs A/B: 300 mg PO bid, If tolerated increase dose to 400 mg PO bid
- Child Pughs C: 200 mg PO bid, If tolerated increase dose to 300 mg PO bid, then 400 mg PO bid
Note Monitor ECG if hepatic impairment
See Supplemental Patient Information
- Nilotinib causes grade 3/4 thrombocytopenia, neutropenia and anemia. Monitor CBC count every two weeks for the first 2 months and then monthly or as clinically indicated. Myelosuppression is generally reversible and usually managed by temporarily withholding the therapy
- Nilotinib causes prolong QT interval resulting in type of ventricular tachycardia (Torsade de pointes), syncope, seizure, and/or death. Correct hypokalemia or hypomagnesemia before starting therapy and perform ECG at baseline and periodically as clinically indicated [US Black Box Warning]
- Avoid concomitant use of strong inhibitors or inducers of CYP3A4
- Sudden deaths have occurred in patients with resistant or intolerant Ph+ CML receiving nilotinib, suggesting the possibility of ventricular repolarization abnormalities
- Nilotinib causes increases in serum lipase, use cautiously in patients with history of pancreatitis. Monitor serum lipase levels monthly or as clinically indicated
- Nilotinib therapy results in elevated bilirubin, AST/ALT, and alkaline phosphatase levels, monitor LFT periodically
- Correct electrolyte abnormalities prior to initiating nilotinib therapy and monitor periodically, as it causes hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia
- Avoid concomitant use of CYP3A4 inhibitors or anti-arrhythmic drugs and other drugs that may prolong QT interval
- Food increases the bioavailability of nilotinib, avoid food 2 hrs before and 1 hr after the dose
- Start with lower recommended dose in patients with hepatic impairment and closely monitor QT interval
- Total gastrectomy reduces the exposure of nilotinib, frequent follow-up, dose increase or alternative therapy may be considered in these patients
- Do not use in patients with galactose intolerance, severe lactase deficiency as capsule contains lactose
- Avoid in pregnancy as the drug may cause fetal harm. Women of child-bearing potential should avoid becoming pregnant during treatment
Cautions: Use cautiously in
- Hepatic impairment
- History of pancreatitis
- Risk of QT prolongation
- Total gastrectomy
- Galactose intolerance
- Concomitant use of CYP3A4 inhibitor
- Cardiac disorder
- Concurrent use of other drugs known to prolong QT interval (avoid use)
- Thyroid disorder
Supplemental Patient Information
- Patients should be advised to take medicine 12 hrs apart, on empty stomach, 1 hr before or 2 hrs after food
- Women of childbearing should be advised to use effective contraceptives
Pregnancy Category:D
Breastfeeding: Safety Unknown; excreted in the milk of rats; Because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Drug Name: Tasigna 200 MG Oral Capsule
Ingredient(s): Nilotinib
Imprint: NVR;BCR
Color(s): Red
Shape: Capsule
Size (mm): 22.00
Score: 1
Inactive Ingredient(s): silicon dioxide / crospovidone / gelatin / lactose monohydrate / magnesium stearate / ferric oxide red / titanium dioxide / ferric oxide yellow
Drug Label Author:
Novartis Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
