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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.


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NEWS HIGHLIGHTS

Media Articles Related to Tasigna (Nilotinib)

Tasigna Shows Promise in Systemic Sclerosis (CME/CE)
Source: MedPage Today Dermatology [2015.08.26]
(MedPage Today) -- Skin scores improved at 12 months, but tolerability limited by mild QTc prolongation

Relapse in leukemia tied to mutations that persist through treatment
Source: Cancer / Oncology News From Medical News Today [2015.08.26]
Focusing on mutations that linger through chemotherapy instead of those present at time of diagnosis may be a better way to predict relapse and survival in acute myeloid leukemia.

Genetic mutations identified during remission may help predict risk of relapse, survival for leukemia patients
Source: Genetics News From Medical News Today [2015.08.26]
In preliminary research, the detection of persistent leukemia-associated genetic mutations in at least 5 percent of bone marrow cells in day 30 remission samples among adult patients with acute...

New similarities between Leukemia and AIDS discovered by Ben-Gurion University of the Negev researchers
Source: HIV / AIDS News From Medical News Today [2015.08.26]
Researchers at Ben-Gurion University of the Negev (BGU) have made a significant breakthrough, discovering similarities between Leukemia and HIV that might hold the key to developing a clinical...

Basis for new treatment options for a fatal leukemia in children revealed
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.07.29]
Detailed molecular analyses allow new insights into the function of tumor cells and options for new treatmentsAcute lymphoblastic leukemia (ALL) leukemia is the most common type of cancer in...

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: 2015-08-26

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