pretomanid
Dovprela (previously Pretomanid FGK) · ATC code J04
- Key facts
- Active substance
- pretomanid
- ATC code
- J04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Dovprela 200 mg tablet
- Marketing authorisation holder
- Viatris Healthcare Limited
- Information as of
- 2026-10-29
Key facts
Pretomanid is an antibacterial of the nitroimidazole class. It is used with bedaquiline and linezolid (with or without moxifloxacin) for rifampicin-resistant pulmonary tuberculosis in adults.
What it is used for
- With bedaquiline, linezolid and moxifloxacin: adults with pulmonary tuberculosis due to rifampicin-resistant M. tuberculosis, with or without isoniazid resistance (Dovprela).
- With bedaquiline and linezolid: adults with pulmonary TB resistant to rifampicin and a fluoroquinolone, with or without isoniazid resistance.
Dosing
- 200 mg (one tablet) once daily for 26 weeks, with food, by directly observed therapy or per local practice.
- Only with bedaquiline (400 mg once daily for 2 weeks, then 200 mg 3 times per week) and linezolid (600 mg daily), with or without moxifloxacin (400 mg once daily); omit moxifloxacin in fluoroquinolone resistance.
- Without moxifloxacin, treatment can be extended to a total of 39 weeks in certain cases.
- If bedaquiline or pretomanid is stopped, the whole regimen should be stopped; missed doses of pretomanid, bedaquiline and moxifloxacin are made up at the end.
- Not recommended in renal impairment; safety in hepatic impairment not established.
Contraindications
- Hypersensitivity to the active substance, other nitroimidazoles or any of the excipients.
Important warnings
- Do not use as part of any regimen other than those recommended.
- Hepatotoxicity: check liver tests at start, weekly in the first month, every other week in month 2 and monthly thereafter; avoid alcohol and other hepatotoxic products.
- Myelosuppression, peripheral and optic neuropathy and lactic acidosis (known linezolid reactions): monitor blood counts and seek eye examination for visual symptoms.
- QT prolongation can occur with the combination regimen.
Side effects
- With bedaquiline and linezolid, most frequent: nausea, vomiting, transaminases increased; also peripheral neuropathy and anaemia.
- With bedaquiline, linezolid and moxifloxacin, most frequent: transaminases increased and QTc prolongation. See the full text for more.
Interactions
- Avoid moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, rifabutin, carbamazepine, phenytoin, St John's wort); rifampicin reduced pretomanid AUC by 66%.
Pregnancy and breastfeeding
- Very limited data; use in pregnancy only if the benefit outweighs the potential risk to the foetus.
- Breast-feeding: see the full text.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Dovprela (previously Pretomanid FGK)Viatris Healthcare Limited · EMEA/H/C/005167
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Dovprela
- Liechtenstein
- Dovprela
- Norway
- Dovprela
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
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Sources
- European Medicines Agency. Dovprela (previously Pretomanid FGK) – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/dovprela-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.