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022068s027lbl.pdf

🔗 Source: accessdata.fda.gov

📊 Size: 1.13 MB

👤 Author: fda/cder

⬇️ Downloads: 145

Summary

Tasigna (nilotinib) is a kinase inhibitor for oral use, initially approved in 2007. It has a warning for QT prolongation and sudden deaths, and is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Tasigna is indicated for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, and for adult patients with Ph+ CML in chronic or accelerated phase who are resistant or intolerant to prior therapy. The recommended dose is 300 mg orally twice daily for newly diagnosed Ph+ CML-CP, and 400 mg orally twice daily for resistant or intolerant Ph+ CML-CP and CML-AP. Common adverse reactions include nausea, rash, headache, fatigue, and myelosuppression.

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Description

Tasigna (nilotinib) is a kinase inhibitor for oral use, initially approved in 2007.

Technical Information

File Format: PDF
File Size: 1.13 MB
Pages: 38
Language: EN
Author: fda/cder
Total Downloads: 145
Last Updated: 2 months ago

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