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Home > Safety and Tolerability

Safety and tolerability profile

TASIGNA® (nilotinib) capsules is well-tolerated with high rates of adherence to therapy and has 10+ years of experience1

 

A consistent tolerability profile has been observed with TASIGNA based on 6- and 10-year follow-up1

  • Consistent safety profile across TASIGNA trials1,2

  • AEs typically presented early during treatment with TASIGNA3

  • Unexpected safety signals have not emerged with long-term therapy1,2

Patients treated with Tasigna. Non-hematologic AEs in TASIGNA trials
An image illustrating the number of patients treated with TASIGNA. Non-hematologic AEs in TASIGNA trials

Serious adverse drug reactions could occur: myelosuppression, QT prolongation, sudden death, cardiovascular events, fluid retention, and hepatitis B reactivation.2

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Well-established tolerability with TASIGNA

Tolerability in TASIGNA
An image illustrating the well-established tolerability with TASIGNA.

Serious adverse drug reactions could occur: myelosuppression, QT prolongation, sudden death, cardiovascular events, fluid retention, and hepatitis B reactivation.2

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Cardiovascular profile

CV risk associated with all TKIs

CV risk associated with all TKIs is managed with regular monitoring and follow-up6

  • CVEs have been reported with all approved TKIs; incidence variations across TKI clinical trials may be due to differences in reporting protocols7-9 

  • CVE rates were similar across 2G TKIs in an independent retrospective analysis at MD Anderson using a consistent, broad range of CV event definitions10

Distribution of CV events in TKIs
Distribution of CV events in TKIs
Holistic

CV events associated with TASIGNA

CV events associated with TASIGNA
An image illustrating incidence of CV events with TASIGNA vs imatinib.

*Definitions of CV diseases include: angina pectoris; coronary artery disease; myocardial infarction; coronary artery occlusion; acute myocardial infarction; angina unstable; coronary artery stenosis; blood creatine phosphokinase MB increased; troponin I increased; troponin increased; troponin T increased; transient ischemic attack; subdural hemorrhage; subdural hematoma; paralysis; cerebrovascular disorder; basilar artery stenosis; amaurosis fugax; monoparesis; hemiparesis; cerebral ischemia; cerebral infarction; carotid artery stenosis; aphasia; ischemic stroke; cerebral hemorrhage; cerebrovascular accident; peripheral arterial occlusive disease; peripheral artery stenosis; intermittent claudication; peripheral ischemia; arterial occlusive disease.11

AE, adverse event; CV, cardiovascular; CVE, cardiovascular event; TKI, tyrosine kinase inhibitor; 2G, second generation; ENESTnd, Evaluation Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients; PAOD, peripheral arterial occlusive disease.

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References: 1. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia. 2016;30(5):1044-1054. 2. Habucky K, Duverger B, Kreft R, Kozlovsky V. TASIGNA® (nilotinib) 50 mg, 150 mg and 200 mg hard capsules core data sheet, version 1.8. West Sussex, United Kingdom: Novartis Europharm Limited; 2016:1-54. 3. Data on file. PSUR. Novartis Pharmaceuticals Corp; 2019. 4. Saglio G, Larson RA, Hughes TP, et al. Efficacy and safety of nilotinib in chronic phase (CP) chronic myeloid leukemia (CML) patients (pts) with type 2 diabetes in the ENESTnd trial. Blood. 2010;116(21):3430. 5. Cortes JE, Hochhaus A, le Coutre PD, et al. Minimal crossintolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011;117(21):5600-5606. 6. Aghel N, Delgado D, Lipton J. Cardiovascular toxicities of BCR-ABL tyrosine kinase inhibitors in chronic myeloid leukemia: preventive strategies and cardiovascular surveillance. Vasc Health Risk Manag. 2017;13:293-303. 7. Hochhaus A, Larson RA, Guilhot F, et al; for the IRIS Investigators. Long-term outcomes of imatinib treatment for chronic myeloid leukemia. N Engl J Med. 2017;376(10):917-927. 8. Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333-2340. 9. Cortes JE, Mauro MJ, Deininger MWN, et al. Bosutinib vs imatinib for newly diagnosed chronic myeloid leukemia in the BFORE trial: 24-month follow-up. J Clin Oncol. 2018;36(suppl 15):7002. 10. Jain P, Kantarjian H, Boddu PC, et al. Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs. Blood Advances. 2019;3(6):851-861. 11. Data on file. Study CAMN107A2303. Novartis Pharmaceuticals Corp; 2014.

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