Bedaquiline is a [[diarylquinoline]] anti-[[tuberculosis]] drug, which was discovered by a team led by [[Koen Andries]] at [[Janssen Pharmaceutica]].<ref name="pmid17387738">{{cite journal | author = de Jonge MR, Koymans LH, Guillemont JE, Koul A, Andries K | title = A computational model of the inhibition of Mycobacterium tuberculosis ATPase by a new drug candidate R207910 | journal = Proteins | volume = 67 | issue = 4 | pages = 971–80 | year = 2007 | month = June | pmid = 17387738 | doi = 10.1002/prot.21376 | url = }}</ref> It is the first new medicine to fight TB in more than forty years,<ref>{{cite web|title=FDA Approves 1st New Tuberculosis Drug in 40 Years|url=http://abcnews.go.com/Health/wireStory/fda-approves-tuberculosis-40-years-18100650#.UOIPT-RQWe0|publisher=ABC News|accessdate=31 December 2012}}</ref><ref>{{cite web|title=F.D.A. Approves New Tuberculosis Drug|url=http://www.nytimes.com/2013/01/01/business/fda-approves-new-tuberculosis-drug.html?_r=0|publisher=New York Times|accessdate=31 December 2012}}</ref> and is specifically approved to treat [[multi-drug-resistant tuberculosis]].
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Bedaquiline fumarate is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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There is limited information regarding Off-Label Guideline-Supported Use of Bedaquiline fumarate in adult patients.
Non–Guideline-Supported Use
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Bedaquiline fumarate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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There is limited information regarding FDA-Labeled Use of Bedaquiline fumarate in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
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There is limited information regarding Off-Label Guideline-Supported Use of Bedaquiline fumarate in pediatric patients.
Non–Guideline-Supported Use
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Bedaquiline fumarate in pediatric patients.
Contraindications
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Warnings
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See full prescribing information for complete Boxed Warning.
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Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Bedaquiline fumarate in the drug label.
Body as a Whole
Cardiovascular
Digestive
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Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
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Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Bedaquiline fumarate in the drug label.