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Print Text Size Glossary Summary of Product Characteristics Safety Information U.S. Residents

This site is intended for Healthcare Professionals outside the U.S.

Newly Diagnosed Patients
Imatinib-resistant/intolerant
Mechanism of Action
Dosing TASIGNA

IMATINIB-RESISTANT OR -INTOLERANT PATIENTS

Powerful, durable responses in imatinib-resistant or -intolerant patients1

The key second-line study of TASIGNA (2101) demonstrated high overall survival and powerful, durable responses in a heavily pretreated population of imatinib-resistant patients and imatinib-intolerant patients who had not achieved a major cytogenetic response (MCyR).

TASIGNA achieved high overall survival rates to prolong the chronic phase1

Overall survival at 24 months in the 2101 Trial
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TASIGNA delivered powerful, durable responses in heavily pretreated patients2

  • 44% achieved CCyR at 24 months
  • 84% maintained CCyR at 24 months
  • 56% of patients with CCyR achieved MMR

TASIGNA has a distinct tolerability profile that may help imatinib-resistant or -intolerant patients maintain therapy1,2

Extensive clinical experience in the second-line setting and recent 24-month follow-up data confirm the favorable tolerability of TASIGNA in imatinib-resistant or -intolerant patients. Most side effects that occur with TASIGNA are mild to moderate and will generally disappear after a few days to a few weeks of treatment. In most cases, they do not lead to discontinuation.

2101 trial 24-month follow-up—TASIGNA had a favorable tolerability profile in heavily pretreated imatinib-resistant or -intolerant patients2

TASIGNA Grade 3/4 myelosupression rates
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2101 Trial: Severe Fluid Retention & Bleeding
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Minimal cross-intolerance between imatinib and TASIGNA3

In the 2101 study, patients who discontinued imatinib due to intolerance were unlikely to experience those same AEs on TASIGNA.3

Minimal cross-intolerance between imatinib and TASIGNA
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Extensive clinical data in imatinib-resistant or -intolerant patients (N=1743)1,2

  • Favorable tolerability shown in the 2101 registration trial and confirmed by a 24-month follow-up (N=321)1,2
  • ENACT is the world’s largest study of any available tyrosine kinase inhibitor in Ph+ CML-CP and demonstrated the favorable safety and tolerability of TASIGNA in 1422 imatinib-resistant or -intolerant patients3

Important safety information

  • TASIGNA can increase the QT interval, which may expose patients to the risk of a fatal outcome
  • TASIGNA should be used with caution in patients who have or are at risk of developing QT prolongation
  • Concomitant use of strong CYP3A4 inhibitors or other drugs that can prolong the QT interval should be avoided with TASIGNA
  • TASIGNA should not be taken with food, and ECGs are recommended prior to initiating therapy and as clinically indicated
2101 Study Patient Information in both Chronic & Accelerated Phases
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*Missing information on imatinib-resistant/intolerant status for one patient


References:
1. TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; December 2010.
2. Kantarjian HM, Giles FJ, Bhalla KN, et al. Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase following imatinib resistance or intolerance: 24-month follow-up results [published online ahead of print November 22, 2010]. Blood. doi:10.1182/blood-2010-03-277152.
3. le Coutre PD, Ceglarek B, Turkina A, et al. Patterns and management of selected adverse events of adult patients with imatinib-resistant or -intolerant chronic myeloid leukemia (CML) from the ENACT (expanding nilotinib access in clinical trials) study. Blood. 2009;114(22):Abstract 1115.

TASIGNA Interactive Game

By using TASIGNA instead of imatinib in patients newly diagnosed with Ph+ CML, could you have fewer resistant or intolerant patients in the future?1

TASIGNA 200-mg capsules come in a convenient blister pack.