FDA label
What is Tasigna used for?
Tasigna contains nilotinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Tasigna lists 3 uses: Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP; Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP; Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP.
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Tasigna, capsule
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA022068). Cross-references to other label sections are left out.
Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP
Tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP
Tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib.
Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP
Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.
Source: DailyMed label, set id 6093952a-5248-45cb-ad17-33716a411146, version 42, effective December 16, 2025. NDC 0078-0526, one of 3 listings for this product.
Questions
What is Tasigna used for?
The FDA label for Tasigna lists 3 uses: Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP; Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP; Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP.
What drug class is Tasigna?
FDA lists nilotinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Tasigna
- Is Tasigna a controlled substance?Federal schedule
- Generic for TasignaFDA Orange Book
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- Generic for DanzitenFDA Orange Book
- Kinase Inhibitors listFDA drug class
- Tasigna Medicare Part D coverageBy plan and state
- NDC 0078-0526Tasigna NDC record
- NDC 0078-0592Tasigna NDC record
- NDC 0078-0951Tasigna NDC record