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,...+
FINANCIAL SUPPORT FOR ELIGIBLE PATIENTS WITH PH+ CML
Eligible patients with private insurance may pay $0 per month
Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product*
*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit www.Copay.NovartisOncology.com or call 1-877-577-7756.
1 MONTH FREE, RIGHT FROM THE START
1 month free for patients new to TASIGNA
Patient Instructions: This voucher is good for 1 month of TASIGNA® (nilotinib) capsules.* Present this voucher at a participating pharmacy along with a valid prescription from your health care professional. Follow the dosage instructions provided by your prescriber.
No purchase required. This free trial is not health insurance. Void where prohibited by law. Product dispensed pursuant to terms and conditions of the voucher. Claim shall not be submitted to any public or private third-party payer of any federal or state health care program for reimbursement. Valid only in the US and Puerto Rico. Offer not valid if reproduced or submitted to any other payer. Prescriber ID# required on prescription. It is illegal for any person to sell, purchase or trade, or offer to sell, purchase or trade, or to counterfeit this voucher.
Pharmacist Instructions: This voucher must accompany a valid prescription. No substitutions permitted. Please dispense at no cost to the patient. For reimbursement, please submit this offer as a primary claim to OPUS Health using BIN# 601341. Do not submit to any other payer, public or private. The information printed on the reverse side should be used when submitting for reimbursement. For questions, please call the Help Desk at 1-800-364-4767. This voucher is the property of Novartis and IQVIA and must be returned upon request. Both parties reserve the right to rescind, revoke, or amend this program without notice.
Support designed to meet patients' needs
Novartis Oncology shares your commitment to helping patients receive the medicines prescribed. Patient Assistance Now Oncology (PANO) provides access to information and our wide range of resources available to your patients in more than 160 languages.
Support for patients includes:
To learn more, call 1-800-282-7630 or visit https://www.patient.novartisoncology.com/financial-assistance/PANO/.
Dedicated support along the TASIGNA journey
The Novartis Patient Navigator Program consists of a dedicated team of specialists who support eligible patients during their journey with TASIGNA.*
Patients who enroll in the program receive a series of phone calls from a specially trained navigator who will support and guide them through various aspects of their treatment with TASIGNA.
Patients can register for the Patient Navigator Program by calling Patient Assistance Now Oncology (PANO) at 1-800-282-7630.
*The Novartis Patient Navigator Program does not involve the practice of nursing or provide clinical advice or counseling.
INDICATIONS for TASIGNA® (nilotinib) Capsules
Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP
TASIGNA is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP
TASIGNA is indicated for the treatment of adult patients with CP and accelerated phase (AP) Ph+ CML resistant or intolerant to prior therapy that included imatinib.
Pediatric Patients With Resistant or Intolerant Ph+ CML-CP
TASIGNA is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP with resistance or intolerance to prior tyrosine kinase inhibitor (TKI) therapy.
IMPORTANT SAFETY INFORMATION for TASIGNA® (nilotinib) Capsules
Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome.
WARNINGS AND PRECAUTIONS
Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia, and anemia. Perform complete blood counts every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding TASIGNA temporarily or dose reduction.
TASIGNA prolongs the QT interval. ECGs should be performed at baseline, 7 days after initiation, periodically as clinically indicated, and following dose adjustments. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically.
Significant prolongation of the QT interval may occur when TASIGNA is inappropriately taken with food and/or strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT. Therefore, co-administration with food must be avoided and concomitant use with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT should be avoided. The presence of hypokalemia and hypomagnesemia may further enhance this effect.
Sudden deaths have been reported in patients with Ph+ CML treated with TASIGNA. The relatively early occurrence of some of these deaths relative to the initiation of TASIGNA suggests the possibility that ventricular repolarization abnormalities may have contributed to their occurrence.
Cardiac and Arterial Vascular Occlusive Events
Cardiovascular events, including arterial vascular occlusive events, were reported in a randomized, clinical trial in patients with newly diagnosed Ph+ CML and observed in the postmarketing reports of patients receiving TASIGNA therapy. Cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive disease, and ischemic cerebrovascular events.
If acute signs or symptoms of cardiovascular events occur, advise patients to seek immediate medical attention. The cardiovascular status of patients should be evaluated and cardiovascular risk factors should be monitored and actively managed during TASIGNA therapy according to standard guidelines.
Pancreatitis and Elevated Serum Lipase
TASIGNA can cause increases in serum lipase. Patients with a previous history of pancreatitis may be at greater risk of elevated serum lipase. If lipase elevations are accompanied by abdominal symptoms, interrupt dosing and consider appropriate diagnostics to exclude pancreatitis. Test serum lipase levels monthly or as clinically indicated.
TASIGNA may result in hepatotoxicity as measured by elevations in bilirubin, AST/ALT, and alkaline phosphatase. Grade 3-4 elevations of bilirubin, AST, and ALT were reported at a higher frequency in pediatric patients than in adults. Monitor hepatic function tests monthly or as clinically indicated.
The use of TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating TASIGNA and monitor these electrolytes periodically during therapy.
Tumor Lysis Syndrome
Tumor lysis syndrome cases have been reported in patients taking TASIGNA who have resistant or intolerant Ph+ CML. Malignant disease progression, high white blood cell counts, and/or dehydration were present in most of these cases. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with TASIGNA.
Serious hemorrhage, including fatal events, from any site, including the GI tract, was reported in patients with Ph+ CML receiving TASIGNA. Monitor patients for signs and symptoms of bleeding and medically manage as needed.
Since the exposure of TASIGNA is reduced in patients with total gastrectomy, perform more frequent monitoring of these patients. Consider dose increase or alternative therapy in patients with total gastrectomy.
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
Complete blood counts should be performed every 2 weeks for the first 2 months and then monthly thereafter. Perform chemistry panels, including electrolytes, calcium, magnesium, liver enzymes, lipid profile, and glucose prior to therapy and periodically. ECGs should be obtained at baseline, 7 days after initiation, and periodically thereafter, as well as following dose adjustments.
Monitor lipid profiles and glucose periodically during the first year of TASIGNA therapy and at least yearly during chronic therapy. Assess glucose levels before initiating treatment with TASIGNA and monitor during treatment as clinically indicated. If test results warrant therapy, physicians should follow their local standards of practice and treatment guidelines.
Grade 3/4 fluid retention including pleural effusion, pericardial effusion, ascites, and pulmonary edema have been reported in patients with Ph+ CML receiving TASIGNA. Monitor patients for signs of severe fluid retention (eg, unexpected rapid weight gain or swelling) and for symptoms of respiratory or cardiac compromise (eg, shortness of breath); evaluate etiology and treat patients accordingly.
Effects on Growth and Development in Pediatric Patients
Adverse reactions associated with growth and development can occur in pediatric patients receiving BCR-ABL tyrosine kinase inhibitors (TKIs). The long-term effects of prolonged treatment with BCR-ABL TKIs on growth and development in pediatric patients are unknown. Monitor growth and development in pediatric patients receiving BCR-ABL TKI treatment.
TASIGNA can cause fetal harm. Advise females to inform their doctor if they are pregnant or become pregnant. Inform female patients of the risk to the fetus and potential for loss of the pregnancy. Advise females of reproductive potential to use effective contraception during treatment and for 14 days after receiving the last dose of TASIGNA. Advise lactating women not to breastfeed during treatment with TASIGNA and for at least 14 days after the last dose.
Monitoring of BCR-ABL Transcript Levels
Monitor BCR-ABL transcript levels in patients eligible for treatment discontinuation using an FDA-authorized test validated to measure molecular response (MR) levels with a sensitivity of at least MR4.5. In patients who discontinue TASIGNA therapy, assess BCR-ABL transcript levels monthly for 1 year, then every 6 weeks for the second year, and every 12 weeks thereafter during treatment discontinuation.
Following a loss of MMR (first line/second line) or confirmed loss of MR4 (2 consecutive measures separated by at least 4 weeks showing loss of MR4 in second line), patients should reinitiate TASIGNA within 4 weeks of when the loss of remission is known to have occurred.
Monitor CBC and BCR-ABL transcripts in patients who reinitiate treatment with TASIGNA due to loss of MR quantitation every 4 weeks until MMR is reestablished and then every 12 weeks.
For patients who fail to achieve MMR after 3 months of treatment reinitiating, BCR-ABL kinase domain mutation testing should be performed.
The most commonly reported nonhematologic adverse reactions (≥ 20%) in adult and pediatric patients receiving TASIGNA were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.
Hematologic adverse drug reactions (all grades) include myelosuppression: thrombocytopenia, neutropenia, and anemia.
Musculoskeletal symptoms (eg, myalgia, pain in extremity, arthralgia, bone pain, spinal pain, or musculoskeletal pain) have been reported in eligible patients who discontinued TASIGNA therapy after attaining a sustained MR4.5. The rate of new musculoskeletal symptoms (all grades) generally decreased from the first year (34%-48%) to the second year (9%-15%) after treatment discontinuation.
DOSE ADJUSTMENTS OR MODIFICATIONS
TASIGNA may need to be temporarily withheld and/or dose reduced for QT prolongation, hepatic impairment, hematologic toxicities that are not related to underlying leukemia, clinically significant moderate or severe nonhematologic toxicities, laboratory abnormalities (lipase, bilirubin, or hepatic transaminase elevations) or concomitant use of strong CYP3A4 inhibitors.
Avoid concomitant use of strong CYP3A4 inhibitors with TASIGNA, or reduce TASIGNA dose if co-administration cannot be avoided. Avoid concomitant use of strong CYP3A4 inducers with TASIGNA. Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors.
Please see full Prescribing Information, including Boxed WARNING, by clicking the link at the top of this page.