| legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII -->
|indication=
| legal_UK = <!-- GSL / P / POM / CD / Class A, B, C -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
newly diagnosed adult patients with Philadelphia chromosome positive [[chronic myeloid leukemia]] (Ph+ CML) in chronic phase and chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant to or intolerant to prior therapy that included [[imatinib]].
<i><span style="color:#FF0000;">QT PROLONGATION AND SUDDEN DEATHS: </span></i>
*Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.14).
*Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2).
*Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8).
*Avoid food 2 hours before and 1 hour after taking the dose (5.9).
<!--Adult Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=
=====Newly Diagnosed Ph+ CML-CP=====
*The recommended dose of Tasigna is 300 mg orally twice daily.
=====Resistant or Intolerant Ph+ CML-CP and CML-AP=====
*The recommended dose of Tasigna (nilotinib) is 400 mg orally twice daily.
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport=
=====Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=
=====Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=
* Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome.
<!--Warnings-->
|warnings=
* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=
* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=
* '''Pregnancy Category'''
|useInPregnancyAUS=
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=
* Oral
* Intravenous
|monitoring=
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose=
===Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=
<!--Mechanism of Action-->
|mechAction=
*
<!--Structure-->
|structure=
*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
|nonClinToxic=
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
<!--Clinical Studies-->
|clinicalStudies=
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
|howSupplied=
*
<!--Patient Counseling Information-->
|fdaPatientInfo=
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=
* ®<ref>{{Cite web | title = | url = }}</ref>
<!--Look-Alike Drug Names-->
|lookAlike=
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
}}
}}
{{SI}}
<!--Pill Image-->
==Overview==
{{PillImage
'''Nilotinib''', in the form of the hydrochloride monohydrate salt, is a [[tyrosine kinase]] [[enzyme inhibitor|inhibitor]] approved as Tasigna® in the USA and the EU for drug-resistant [[chronic myelogenous leukemia]] (CML)<ref> Novartis 29/10/2007 Press Release.</ref>. In June 2006, a [[Clinical trial#Phase I|Phase I]] [[clinical trial]] found nilotinib, also known by its clinical code '''AMN107''', has a relatively favorable safety profile and shows activity in cases of CML resistant to treatment with [[imatinib]] ('''Gleevec®'''), another tyrosine kinase inhibitor currently used as a first-line treatment.<ref>{{cite journal | author = Kantarjian H ''et al.'' | title = Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL | journal = N Engl J Med | volume = 354 | issue = 24 | pages = 2542-51 | year = 2006 | id = PMID 16775235}}</ref> In that study 92% of patients (already resistant or unresponsive to Gleevec) achieved a normal white blood cell counts after 5 month of treatment. <ref>http://cws.huginonline.com/N/134323/PR/200606/1056533_5.html Patients with treatment-resistant leukemia achieve high responses to Tasigna® (nilotinib) in first published clinical trial results - Novartis 14/06/2006 Press Release.</ref>
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
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The drug will carry a black box warning for possible heart complications. <ref>http://www.fda.gov/bbs/topics/NEWS/2007/NEW01734.html FDA Approves Tasigna for Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia - FDA 31/10/2007 Press Release</ref>
<!--Label Display Image-->
==References==
{{LabelImage
<div class="references-small">
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
<references/>
}}
</div>
{{Chemotherapeutic agents}}
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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Black Box Warning
WARNING
See full prescribing information for complete Boxed Warning.
QT PROLONGATION AND SUDDEN DEATHS:
Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.14).
Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2).
Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8).
Avoid food 2 hours before and 1 hour after taking the dose (5.9).
The recommended dose of Tasigna is 300 mg orally twice daily.
Resistant or Intolerant Ph+ CML-CP and CML-AP
The recommended dose of Tasigna (nilotinib) is 400 mg orally twice daily.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Nilotinib in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilotinib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Nilotinib in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Nilotinib in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nilotinib in pediatric patients.
Contraindications
Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome.
Warnings
WARNING
See full prescribing information for complete Boxed Warning.
QT PROLONGATION AND SUDDEN DEATHS:
Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.14).
Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2).
Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8).
Avoid food 2 hours before and 1 hour after taking the dose (5.9).
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Nilotinib in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Nilotinib in the drug label.