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Tasigna (Nilotinib) - Summary

 
 



WARNING: QT PROLONGATION AND SUDDEN DEATHS

Tasigna prolongs the QT interv al (5.2) . Sudden deaths have been reported in patients receiving nilotinib (5.3) . Tasigna should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome (4) . Hypokalemia or hypomagnesemia must be corrected prior to Tasigna administration and sh ould be periodically monitored (5.2) . Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided (5.7) . Patients should avoid food 2 hours befo re and 1 hour after taking dose (5.8) . Use with caution in patients wi th hepatic impairment (5. 9 ) . ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments . (5.2, 5.3, 5.6, 5.12)

 

TASIGNA SUMMARY

Tasigna (nilotinib) belongs to a pharmacologic class of drugs known as kinase inhibitors.

Tasigna (nilotinib) is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [ See Clinical Studies (14)]. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.


See all Tasigna indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Tasigna (Nilotinib)

CAR T-Cells in Leukemia: Expert Commentary
Source: Medscape Hematology-Oncology Headlines [2014.10.16]
An expert comments on the dramatic results that were reported this week with chimeric antigen receptor (CAR)-modified T-cells in patients with relapsed acute lymphoblastic leukemia.
Medscape Medical News

Neil Shah, MD, PhD: How I Treat Chronic Myeloid Leukemia
Source: Medscape Hematology-Oncology Headlines [2014.10.16]
Jerald Radich, MD, poses a series of questions on the management of chronic myeloid leukemia to Neil Shah, MD, PhD, who describes his approach to managing the disease.
Medscape Oncology

CARs Motor Through Leukemia, Part 2: 'Landscape Changing'
Source: Medscape Hematology-Oncology Headlines [2014.10.15]
Another group reports remarkable results with chimeric antigen receptor (CAR)-modified T-cells in patients with acute lymphoblastic leukemia.
Medscape Medical News

CNIO researchers associate 2 oncogenes with the aggressiveness and incidence of leukemia in mice
Source: Cancer / Oncology News From Medical News Today [2014.10.14]
Proteins regulating cell division determine tumour growth. Ongoing clinical trials are currently studying inhibitors for two of these proteins, Cdk4 and Cdk6, targeting several types of cancer...

CARs Motor Through Leukemia, Can 'Eradicate' Disease
Source: Medscape Hematology-Oncology Headlines [2014.10.13]
Clinical results reported by National Cancer Institute researchers show that chimeric antigen receptor (CAR)-modified T-cells can wipe out leukemia.
Medscape Medical News

more news >>

Published Studies Related to Tasigna (Nilotinib)

Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. [2011.09]
BACKGROUND: Nilotinib has shown greater efficacy than imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase after a minimum follow-up of 12 months. We present data from the Evaluating Nilotinib Efficacy and Safety in clinical Trials-newly diagnosed patients (ENESTnd) study after a minimum follow-up of 24 months... INTERPRETATION: Nilotinib continues to show better efficacy than imatinib for the treatment of patients with newly diagnosed CML in chronic phase. These results support nilotinib as a first-line treatment option for patients with newly diagnosed disease. FUNDING: Novartis. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Comparative efficacy of nilotinib and dasatinib in newly diagnosed chronic myeloid leukemia: a matching-adjusted indirect comparison of randomized trials. [2011.06]
OBJECTIVE: Nilotinib and dasatinib have not been directly compared in a randomized trial for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP). The purpose of this study was to indirectly compare rates of major molecular response (MMR), progression-free survival (PFS) and overall survival by month 12 with nilotinib and dasatinib treatment of newly diagnosed CML-CP... CONCLUSION: Nilotinib was associated with significantly higher rates of MMR and overall survival compared with dasatinib by month 12 in the treatment of newly diagnosed CML-CP.

Nilotinib as frontline therapy for patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase: results from the Japanese subgroup of ENESTnd. [2011.05]
Recent results from the phase 3 ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients) study have demonstrated superiority of nilotinib over imatinib for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (CML-CP)...

Nilotinib: evaluation and analysis of its role in chronic myeloid leukemia. [2011.02]
Nilotinib, formally known as AMN107, is a second-generation tyrosine kinase inhibitor, rationally designed from its revolutionary parent compound imatinib, to produce a 30-40-fold enhancement in the inhibition of the BCR-ABL1-derived oncoprotein associated with chronic myeloid leukemia... With the emergence of supportive trial data, it is likely to have a leading role both in the front-line management of newly presenting patients and in the second-line treatment of patients resistant to or intolerant of imatinib and other second-line agents.

Effects of nilotinib on single-dose warfarin pharmacokinetics and pharmacodynamics: a randomized, single-blind, two-period crossover study in healthy subjects. [2011]
BACKGROUND AND OBJECTIVE: Nilotinib (Tasigna(R)), a highly selective and potent BCR-ABL tyrosine kinase inhibitor, is approved for the treatment of chronic myeloid leukaemia in the chronic phase (CML-CP) and the accelerated phase (CML-AP) in patients resistant or intolerant to prior therapy, including imatinib. Nilotinib has shown competitive inhibition of cytochrome P450 enzyme (CYP) 2C9 in vitro, but its effect on CYP2C9 activity in humans is unknown. This study evaluated the effects of nilotinib on the pharmacokinetics and pharmacodynamics of warfarin, a sensitive CYP2C9 substrate, in healthy subjects... CONCLUSION: The study results demonstrate that nilotinib has no effect on single-dose warfarin pharmacokinetics and pharmacodynamics. This implies that nilotinib is unlikely to inhibit CYP2C9 activity in human subjects. These findings suggest that warfarin and nilotinib may be used concurrently as needed.

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Clinical Trials Related to Tasigna (Nilotinib)

Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) [Recruiting]
Patients with advanced GIST are treated with imatinib. This study seeks to look at a new therapeutic agent at the time of tumor progression following treatment with 600-800 mg daily of imatinib. The study is looking to see if Nilotinib (tasigna) alone or in combination with imatinib (gleevec) is more effective at controlling disease.

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations [Recruiting]
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment [Recruiting]
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Imatinib Mesylate (Glivec) as Maintenance Therapy After Cytogenetic Response With Nilotinib (AMN107, Tasigna) First Line in Newly Diagnosed Chronic Myelogenous Leukemia [Recruiting]
The results of the International Randomized Study of Interferon and STI571 (IRIS) trial indicate that in patients with chronic phase CML treated with first line imatinib, achievement of a complete or partial cytogenetic response (CCyR or PCyR) at 12 months is associated with a significantly better progression-free survival (PFS).

Second generation tyrosine kinase inhibitors such as nilotinib can overcome imatinib resistance because of greater potency to bind to BCR-ABL. Recent results indicate that, in patients with previously untreated chronic phase CML, nilotinib results in a faster and higher rate of CCyR or PCyR than imatinib. However, nilotinib use is associated with diet restriction and much higher financial cost.

The primary objective of this study is to evaluate the ability of imatinib to maintain a complete cytogenetic response (CcyR) in patients who achieved a CCyR after 12 months of first-line treatment with nilotinib.

Study of Tasigna�/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas [Recruiting]
The purpose of this Pilot Study is to determine if NF1 patients with plexiform neurofibromas treated with Tasgina® respond to therapy.

more trials >>

Reports of Suspected Tasigna (Nilotinib) Side Effects

Fatigue (185)Nausea (175)Death (167)Dyspnoea (166)Rash (153)Pruritus (134)Electrocardiogram QT Prolonged (126)Pyrexia (120)Headache (110)Neoplasm Malignant (110)more >>


Page last updated: 2014-10-16

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