The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA
Today FDA updated the product label for the cancer drug Tasigna (nilotonib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML). With today’s updated dosing recommendations, patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna.
Today’s action adds information to the product label for patients and health care providers regarding the conditions under which patients may be eligible to discontinue treatment and notes that if treatment is stopped patients must be regularly monitored for disease recurrence.
The information about discontinuing Tasigna was based on two single-arm trials of patients with Ph+ chronic phase CML. The trials measured how long patients were able to stop taking Tasigna without the leukemia returning (treatment-free remission, or TFR). In both trials, patients had to meet rigorous criteria showing how their cancer had responded to treatment before stopping Tasigna. An important part of both trials was regular and frequent monitoring of specific genetic (RNA) information that specifies the BCR-ABL protein level in the blood with a diagnostic test that has received FDA marketing authorization. Monitoring with a test able to detect reductions of specific RNA information with high accuracy and precision is critical to the safe discontinuation of Tasigna, as this monitoring provides the first signs of relapse.
Common side effects in patients who discontinued Tasigna include musculoskeletal symptoms such as body aches, bone pain and pain in extremities. Some patients experienced prolonged musculoskeletal symptoms.
Common side effects of taking Tasigna include nausea, rash, headache, fatigue, itching (pruritus), vomiting, diarrhea, cough, constipation, joint pain (arthralgia), upper respiratory inflammation (nasopharyngitis), fever (pyrexia), night sweats, low levels of low blood platelets (thrombocytopenia) and low levels of certain blood cells (myelosuppression or thrombocytopenia, neutropenia and anemia).
Severe side effects of taking Tasigna include myelosuppression, blockages in the heart or arteries (cardiac and arterial vascular occlusive events), inflammation of the pancreas and high levels of enzymes in the blood (pancreatitis and elevated serum lipase), severe liver damage (hepatotoxicity), abnormal levels of electrolytes in the blood, metabolic abnormalities (tumor lysis syndrome), severe bleeding (hemorrhage), drug interactions with CYP3A4 inhibitors, total surgical removal of the stomach (gastrectomy) and fluid retention. Women who are pregnant or breastfeeding should not take Tasigna because it may cause harm to a developing fetus or newborn baby.
Severe side effects typically associated with Tasigna administration occurred less frequently in patients who discontinued Tasigna. However, the long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time.
The labeling for Tasigna contains a boxed warning to alert health care professionals and patients about the risk of abnormal heart rhythm (QT prolongation) and sudden death. Tasigna should not be taken by patients with low levels of potassium in the blood (hypokalemia), low levels of magnesium in the blood (hypomagnesemia), or QT prolongation. Sudden deaths have been reported in patients taking Tasigna. The boxed warning also states Tasigna should not be given with drugs known to prolong the QT interval or with strong CYP3A4 inhibitors. Patients should not eat two hours prior to or one hour after taking Tasigna.
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