There are common side effects which include headache, dizziness, and nausea.[3] Other side effects include QT prolongation.[2] Delamanid works by blocking the manufacture of mycolic acids thus destabilising the bacterial cell wall.[4] It is in the nitroimidazole class of medications.[5]
Common side effects include headache, dizziness, and nausea.[3] Other side effects include QT prolongation.[2] Use in pregnancy has not been extensively studied, but there have been reports of success[9] and it is currently recommended as part of the standard treatment regimen for pregnant women with rifampicin-resistant tuberculosis in South Africa.[10]
Interactions
Delamanid is metabolised by the liver enzyme CYP3A4; therefore strong inducers of this enzyme can reduce its effectiveness.[11]
Mechanism of action
Delamanid is activated in the mycobacterium by deazaflavin-dependent nitroreductase (Ddn), an enzyme which uses dihydro-F420 (reduced form), into nitric oxide and a highly reactive metabolite. This metabolite attacks the synthesis enzyme DprE2, which is important for the synthesis of cell wall arabinogalactan, to which mycolic acid would be attached. This mechanism is shared with pretomanid. Clinical isolates resistant to this drug tend to have mutations in the biosynthetic pathway for Coenzyme F420.[12]
The European Medicines Agency (EMA) recommended conditional marketing authorization for delamanid in adults with multidrug-resistant pulmonary tuberculosis without other treatment options because of resistance or tolerability. The EMA considered the data show that the benefits of delamanid outweigh the risks, but that additional studies were needed on the long-term effectiveness.[15]
Society and culture
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The medication was not readily available globally as of 2015. It was believed that pricing will be similar to bedaquiline, which for six months is approximately US$900 in low income countries, US$3,000 in middle income countries, and US$30,000 in high income countries.[2] As of 2016 the Stop TB Partnership had an agreement to get the medication for US$1,700 per six month.[8]
^ abcdefgWorld Health Organization (2015). The selection and use of essential medicines. Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization. pp. 30–1. hdl:10665/189763. ISBN9789241209946. ISSN0512-3054. WHO technical report series;994.
^ abSmith MR, Accinelli A, Tejada FR, Kharel MK (2016). "Drugs Used in Tuberculosis and Leprosy". In Ray SD (ed.). Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions. Elsevier. p. 284. ISBN978-0-444-63889-2. Archived from the original on 2016-12-20.
^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.