Active Ingredient: Nilotinib
Nilotinib is indicated for the treatment of:
For this indication, competent medicine agencies globally authorize below treatments:
Oral
460 - 460 mg per m² of body surface area (BSA)
From 230 To 230 mg per m² of body surface area (BSA) 2 time(s) per day every day
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose.
Dosing in paediatric patients is individualised and is based on body surface area (mg/m²). The recommended dose of nilotinib is 230 mg/m² twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see table).
There is no experience with treatment of paediatric patients below 2 years of age. There are no data in newly diagnosed paediatric patients below 10 years of age and limited data in imatinib-resistant or intolerant paediatric patients below 6 years of age.
Paediatric dosing scheme of nilotinib 230 mg/m² twice daily:
| Body Surface Area (BSA) | Dose in mg (twice daily) |
|---|---|
| Up to 0,32 m² | 50 mg |
| 0,33–0,54 m² | 100 mg |
| 0,55–0,76 m² | 150 mg |
| 0,77–0,97 m² | 200 mg |
| 0,98–1,19 m² | 250 mg |
| 1,20–1,41 m² | 300 mg |
| 1,42–1,63 m² | 350 mg |
| ≥1,64 m² | 400 mg |
Nilotinib should be taken twice daily approximately 12 hours apart and must not be taken with food. No food should be consumed for 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.
The absorption and bioavailability of nilotinib are increased if it is taken with food, resulting in a higher serum concentration.
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