About nilotinib hydrochloride monohydrate
BCR-ABL tyrosine kinase inhibitor
Used for
- Treats Philadelphia chromosome-positive chronic myeloid leukemia in adults, including newly diagnosed disease and disease resistant to other treatment.
Usual adult dose
Usually 300 mg twice daily for newly diagnosed disease, or 400 mg twice daily for resistant or intolerant disease.
Usual dose in children
For children aged 1 year and older, dosing is based on body surface area, usually twice daily; specialist supervision is required.
Common side effects
- Low blood counts
- Nausea, diarrhea, or constipation
- Rash, itching, or headache
- Elevated blood sugar or liver enzymes
Important warnings
- Can cause serious heart rhythm changes; monitoring is required.
- May cause sudden death, pancreatitis, or severe liver problems.
- Take on an empty stomach, avoiding food for two hours before and one hour after.
- Avoid grapefruit; blood tests and ECG monitoring are needed.
Pregnancy
May harm an unborn baby. Effective contraception is recommended during treatment and for two weeks after the last dose.
Breastfeeding
Breastfeeding is not recommended during treatment and for two weeks after the last dose.
Interactions
- Strong CYP3A inhibitors or inducers can change nilotinib levels.
- QT-prolonging medicines may increase dangerous heart rhythm risk.
- Medicines that reduce stomach acid may affect absorption.
- Avoid St John’s wort and grapefruit products.
AI-generated from general medical knowledge, not from this product's official leaflet. It may be incomplete or out of date. Not medical advice — ask a pharmacist or doctor before making any decision.