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Tasigna (Nilotinib) - Summary

 


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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 >>

TASIGNA NEWS HIGHLIGHTS

Media Articles Related to Tasigna (Nilotinib)

High Dose Chemotherapy Significantly Prolongs Survival For Patients With Acute Myeloid Leukemia
Source: Lymphoma / Leukemia News From Medical News Today [2008.11.19]

Cold/Flu Breakthrough Remedy Undergoes NCI-Sponsored Trial In Leukemia Patients: Canada
Source: Flu / Cold / SARS News From Medical News Today [2008.11.18]

INNO-406 Demonstrates Positive Clinical Responses In Phase 1 Trial In Patients With Chronic Myeloid Leukemia
Source: Blood / Hematology News From Medical News Today [2008.11.13]

CIGNA To Promote The Leukemia & Lymphoma Society's Co-Pay Assistance Program, USA
Source: Lymphoma / Leukemia News From Medical News Today [2008.11.07]

Blocking A Histone-Modifying Enzyme May Calm Down Gene Expression Driving Some Leukemias
Source: Lymphoma / Leukemia News From Medical News Today [2008.11.05]

more >>

Published Studies Related to Tasigna (Nilotinib)

Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib. [2008.09.01]

Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia. [2008.08.01]

Nilotinib: a novel Bcr-Abl tyrosine kinase inhibitor for the treatment of leukemias. [2008.07]

Dual inhibition of c-abl and PDGF receptor signaling by dasatinib and nilotinib for the treatment of dermal fibrosis. [2008.07]

Comparison of imatinib, dasatinib, nilotinib and INNO-406 in imatinib-resistant cell lines. [2008.06]

more >>

Clinical Trials Related to Tasigna (Nilotinib)

Nilotinib in Advanced GIST [Recruiting]

Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers [Not yet recruiting]

Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) [Recruiting]

Nilotinib Versus Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR [Not yet recruiting]

Nilotinib as First-Line Treatment of Ph+ CML in Early Chronic Phase [Recruiting]

more >>

Page last updated: 2008-11-19

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