Ph+ CML, Philadelphia chromosome–
positive chronic myeloid leukemia; CP, chronic phase.
positive chronic myeloid leukemia; CP, chronic phase.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
- TASIGNA® (nilotinib) is indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of TASIGNA is based on major molecular response and cytogenetic response rates
- TASIGNA is indicated for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates
IMPORTANT SAFETY INFORMATION FOR TASIGNA® (nilotinib) Capsules
WARNING: QT PROLONGATION AND SUDDEN DEATHS
- TASIGNA prolongs the QT interval. Prior to TASIGNA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline, 7 days after initiation, and periodically thereafter, and following any dose adjustments
- Sudden deaths have been reported in patients receiving nilotinib. Do not administer TASIGNA to patients with hypokalemia, hypomagnesemia, or long QT syndrome
- Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors
- Avoid food 2 hours before and 1 hour after taking dose
- Myelosuppression: Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia, and anemia. Complete blood counts should be performed every 2 weeks for the first 2 months and then monthly thereafter
- Cardiac and Arterial Vascular Occlusive Events: Cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive disease, and ischemic cerebrovascular events have been reported
- Pancreatitis and Elevated Serum Lipase: TASIGNA can cause increases in serum lipase. Caution is recommended in patients with a history of pancreatitis
- Hepatotoxicity: The use of TASIGNA may result in elevations in bilirubin, AST/ALT, and alkaline phosphatase
- Electrolyte Abnormalities: TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia
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Drug Interactions:
- The concomitant use of strong CYP3A4 inhibitors or anti-arrhythmic drugs and other drugs that may prolong the QT interval should be avoided. Grapefruit products should also be avoided
- The concomitant use of strong CYP3A4 inducers should be avoided. The concomitant use of proton pump inhibitors with TASIGNA is not recommended
- When the concurrent use of a H2 blocker is necessary, administer approximately 10 hours before and approximately 2 hours after the TASIGNA dose. If necessary, an antacid may be administered approximately 2 hours before or approximately 2 hours after the TASIGNA dose
- Food Effects: TASIGNA must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose is taken
- Hepatic Impairment: TASIGNA exposure is increased in patients with impaired hepatic function
- Tumor Lysis Syndrome: Cases of tumor lysis syndrome have been reported in TASIGNA-treated patients who were resistant or intolerant to prior CML therapy. Due to potential for tumor lysis syndrome, maintain adequate hydration and correct uric acid levels prior to initiating therapy with TASIGNA
- Hemorrhage: Grade 3/4 hemorrhage from various sites including GI were reported in patients receiving TASIGNA
- Total Gastrectomy: The exposure of TASIGNA is reduced in patients with total gastrectomy
- Lactose: Since the capsules contain lactose, TASIGNA is not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency with a severe degree of intolerance to lactose-containing products, or of glucose-galactose malabsorption
- Monitoring Laboratory Tests: Chemistry panels, including electrolytes, calcium, magnesium, lipid profile, liver enzymes, and glucose should be checked prior to therapy and periodically
- Embryo-Fetal Toxicity: Women of childbearing potential should avoid becoming pregnant while taking TASIGNA and should be advised of the potential hazard to the fetus if they do
- Fluid Retention: Grade 3/4 fluid retention including pleural effusion, pericardial effusion, ascites and pulmonary edema have been reported in patients receiving TASIGNA
- ADVERSE REACTIONS: The most commonly reported non-hematologic adverse reactions (≥20% in patients) were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats. Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia and anemia
- DOSE ADJUSTMENTS OR MODIFICATIONS: TASIGNA may need to be temporarily withheld and/or dose reduced for QT prolongation, hematologic toxicities that are not related to underlying leukemia, clinically significant moderate or severe non-hematologic toxicities, laboratory abnormalities or concomitant use of strong CYP3A4 inhibitors
Please see full Prescribing Information, including Boxed WARNING.