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)
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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]
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]
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]
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