Nilotinib

نیلوتینیب

⚠ Unverified

🎗️ 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

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

👥 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.”

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