Posted from: Tuesday, April 03, 2018 - 04:05 PM - Present

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.


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Friday, October 18, 2019 - 01:20 AM.