FDA Updates Tasigna Label
December 26, 2017 – The U.S. FDA has updated the label for Tasigna® (nilotinib), manufactured by Novartis, to indicate that certain patients with early (chronic) phase chronic myeloid leukemia (CML) who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria, may be eligible to stop taking the drug.
Whether or not a patient may be able to stop treatment with Tasigna is determined by an FDA-approved test that monitors specific genetic information and provides the first signs of CML remission. However, the FDA cautions that even if patients are able to stop treatment, they should be regularly monitored for CML recurrence.
Many patients diagnosed with CML must continue treatment for the disease for the rest of their lives, and being eligible to stop Tasigna does not guarantee that CML will not return. The long-term effects of discontinuing treatment with the drug are not yet known. Common side effects of discontinuing Tasigna include body aches, bone pain, and pain in the extremities. In some cases, these symptoms may be prolonged.
Tasigna was originally approved in 2007 for the treatment of patients who have Philadelphia chromosome positive (Ph+) CML. It is also indicated to treat chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib. Recommended dosing is based on the indication. The drug carries a black box warning that it prolongs the QT interval (a part of the heart’s electrical cycle), and sudden deaths have been reported in patients taking Tasigna. Prolonged QT intervals can be indicators of possible ventricular tachyarrhythmias, and are a risk factor for sudden death.
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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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