Nilotinib
نیلوتینیب
🎗️ Antineoplastic And Immunomodulating AgentsBCR-ABL tyrosine kinase inhibitor
Market / country: 🇺🇸 USA
Tasigna (US)
🧮 Dose calculator
Chronic myeloid leukaemia (CML) · Regimen source: FDA Tasigna · 2.1
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Tasigna · 2.1
- • Every 12 h; no food for 2 h before and 1 h after. Children: 230 mg/m² twice daily rounded to nearest 50 mg (max 400 mg per dose). FDA Tasigna · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypokalaemia, hypomagnesaemia or long QT syndrome. FDA Tasigna · 4
Warnings
- • Boxed warning: QT prolongation and sudden deaths — ECG at baseline, day 7 and periodically; correct potassium and magnesium; avoid food and strong CYP3A4 inhibitors. FDA Tasigna · Boxed Warning
- • Myelosuppression; cardiac and arterial vascular occlusive events; pancreatitis; hepatotoxicity; haemorrhage; fluid retention. FDA Tasigna · 5
Formulations
- 50 mg capsule — capsule 🇺🇸 USA FDA Tasigna · 3
- 150 mg capsule — capsule 🇺🇸 USA FDA Tasigna · 3
- 200 mg capsule — capsule 🇺🇸 USA FDA Tasigna · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Tasigna · 8.1
“Risk Summary Based on findings from animal studies and the mechanism of action, Tasigna can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] .”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Tasigna · 8.2
“Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Tasigna and for 14 days after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Tasigna · 8.4
“The safety and effectiveness of Tasigna have been established in pediatric patients greater than or equal to 1 year of age with newly diagnosed and resistant or intolerant Ph+ CML in chronic phase [see Clinical Studies (14.5)] .”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tasigna · 8.5
“In the clinical trials of Tasigna (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over, respectively.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Tasigna · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with Tasigna and for 14 days after the last dose.”
🔗 Reference links
- FDA (approval record)NDA022068
- DailyMed (FDA label)FDA Tasigna
- MedlinePlus (NIH)Nilotinib
- WHO ATC/DDDL01EA03
- Darooyab (Iran)Nilotinib
🇮🇷 Registered in Iran Darooyab · G-4782/Nilotinib
Dosage forms with Iranian generic codes, per Darooyab.
- 12273 · NILOTINIB 200MG CAP · کپسول نیلوتینیب ۲۰۰ میلیگرم
- 13251 · NILOTINIB 200MG TAB · قرص نیلوتینیب ۲۰۰ میلیگرم
- 11467 · NILOTINIB 400MG TAB · قرص نیلوتینیب ۴۰۰ میلیگرم
- 51798 · NILOTINIB 150MG CAP · کپسول نیلوتینیب ۱۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tasigna · 3FDA Tasigna · 2.1FDA Tasigna · 4FDA Tasigna · Boxed WarningFDA Tasigna · 5FDA Tasigna · SPL approval / marketing categoryFDA Tasigna · 8.1FDA Tasigna · 8.2FDA Tasigna · 8.4FDA Tasigna · 8.5FDA Tasigna · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4782/Nilotinib
- Clinical review⚠ Unverified