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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)

In highly lethal type of leukemia, cancer gene predicts treatment response
Source: Cancer / Oncology News From Medical News Today [2016.11.25]
Patients with the most lethal form of acute myeloid leukemia (AML) - based on genetic profiles of their cancers - typically survive for only four to six months after diagnosis, even with aggressive...

Juno Says Two Patients Die in Leukemia Drug Trial
Source: Medscape Medical News Headlines [2016.11.23]
Juno Therapeutics Inc said two more patients had died after suffering cerebral edema during a trial of its experimental leukemia drug, bringing the total to five.
Reuters Health Information

Potential targeted therapy found for newly identified leukemia subtype with poor outcome
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.11.10]
An international research team led by St. Jude Children's Research Hospital investigators has uncovered details of a new, high-risk subtype of acute lymphoblastic leukemia (ALL) as well as a...

Genetic hallmarks of acute lymphoblastic leukemia subtype uncovered
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.10.25]
St. Jude Children's Research Hospital - Washington University Pediatric Cancer Genome Project team identifies genetic changes underlying a type of B-precursor acute lymphoblastic leukemiaAn...

Low cost method for examining single leukemia cells could transform treatment
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.10.18]
Leukemia is a disease in which each cell can exhibit different genetic traits, and now Swedish researchers have found a cheap way to examine the individual cells.

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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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: 2016-11-25

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