Tasigna Receives New Indications
March 22, 2018 – The U.S. FDA has approved new indications for Tasigna® (nilotinib), manufactured by Novartis, to treat both children at least one year of age and teens at who have chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Approximately 3% of pediatric patients with newly diagnosed lymphoma have CML, according to the Leukemia and Lymphoma Society. A lack of study into treatment options for these patients has led to a lack of standardized treatments, with protocols often based on approaches used in adults.
A tyrosine kinase inhibitor (TKI), Tasigna can inhibit cancer growth by selectively blocking signals from enzymes. It can be used in patients who have never received TKIs before, or who have been treated with TKIs that caused intolerable side effects. Recommended dosing under the pediatric indication is 230mg/m2 of body surface area twice per day, up to a maximum of 400mg per dose. The drug should be taken either two hours before or one hour after eating.
Tasigna has been associated with prolonged QT intervals (a disruption of normal heart rhythms) and sudden death, according to a black box warning. Patients should be carefully monitored through electrocardiograms during treatment with Tasigna.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.