FULLY FDA APPROVED
FOR THE TREATMENT OF ADULTS WITH NEWLY DIAGNOSED Ph+ CML-CP
GET CLOSER TO LONG-TERM RESULTS
THE ONLY TKI WITH 5-YEAR OS DATA
IN THE PI vs IMATINIB
HIGHER ESTIMATED RATE OF SURVIVAL AT 5 YEARS1,2
93.7%
VS
TASIGNA® (nilotinib)
300 mg bid (n=282)
(95% CI, 90.8%-96.6%)
91.7%
IMATINIB
400 mg qd (n=283)
(95% CI, 88.3%-95.0%)
• Median OS was not reached in either arm during the study2
TKI, tyrosine kinase inhibitor; OS, overall survival.
ENESTnd study design: A randomized, controlled, open-label, multicenter Phase 3 trial of 846 patients with newly diagnosed Ph+ CML-CP. Patients were randomized to receive either TASIGNA 400 mg bid (n=281), TASIGNA 300 mg bid
(n=282), or imatinib 400 mg qd (n=283). The daily dose of imatinib could be escalated to 800 mg (400 mg bid), but no dose escalation was permitted with TASIGNA. A centralized laboratory was used for real-time quantitative polymerase
chain reaction (RQ-PCR) testing. The primary end point was MMR at 12 months: TASIGNA 44% (95% CI, 38%-50%) vs imatinib 22% (18%-28%); P<.0001. MMR was defined as ≥3 logs below baseline (≤0.1% International Scale [IS])
as measured by RQ-PCR assay.2,3
IMPORTANT SAFETY CONSIDERATIONS
• Electrolyte Abnormalities: TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia
• 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
Please see brief summary of Prescribing Information, including Boxed WARNING, on the following pages.