Dovprela (Pretomanid)
Nitroimidazole antibiotic for drug-resistant tuberculosis
Dovprela contains the active substance pretomanid, a nitroimidazole antibiotic specifically developed for drug-resistant pulmonary tuberculosis (TB). It is used exclusively in adults as part of combination regimens – either the BPaL regimen (bedaquiline, pretomanid, linezolid) for extensively drug-resistant TB (XDR-TB), or the BPaLM regimen (adding moxifloxacin) for rifampicin-resistant TB. The standard treatment course is 26 weeks and represents a major breakthrough in TB treatment, replacing regimens that previously lasted 18–24 months.
Quick Facts
Key Takeaways
- Dovprela (pretomanid) is a novel antibiotic used only in combination with bedaquiline and linezolid for the treatment of drug-resistant pulmonary tuberculosis in adults.
- The 26-week BPaL/BPaLM regimen is a major advance, replacing older 18–24 month injectable-based regimens with significantly improved cure rates.
- Regular monitoring of liver function, complete blood counts, ECG, and vision is essential throughout treatment due to risks of hepatotoxicity, myelosuppression, QT prolongation, and neuropathy.
- Alcohol must be avoided during treatment, and strong CYP3A4 inducers (such as rifampicin, efavirenz, carbamazepine, St. John's Wort) are contraindicated as they reduce pretomanid levels.
- Dovprela should be taken once daily with food at the same time as companion medications, and treatment must not be stopped without medical supervision.
What Is Dovprela and What Is It Used For?
Dovprela contains the active substance pretomanid, which belongs to the nitroimidazole class of antibiotics. Antibiotics are medicines that kill bacteria causing disease. Pretomanid was specifically developed by the TB Alliance (a non-profit organisation) to address the global crisis of drug-resistant tuberculosis, and it represents the first new class of anti-TB drugs approved in decades.
Tuberculosis remains one of the world's deadliest infectious diseases, killing approximately 1.3 million people annually according to the World Health Organization (WHO). Drug-resistant forms of TB pose an even greater challenge, as they do not respond to standard first-line antibiotics such as rifampicin and isoniazid. Dovprela was developed specifically for these difficult-to-treat forms of TB.
Dovprela is used in two combination regimens for adults aged 18 years and older:
- BPaLM regimen: Dovprela together with bedaquiline, linezolid, and moxifloxacin, for the treatment of pulmonary TB that is resistant to rifampicin (and may also be resistant to isoniazid). This four-drug combination is now recommended by the WHO as the preferred regimen for rifampicin-resistant TB.
- BPaL regimen: Dovprela together with bedaquiline and linezolid, for the treatment of pulmonary TB that is resistant to multiple classes of antibiotics (including rifampicin and a fluoroquinolone), and which may also be resistant to isoniazid. This three-drug regimen is used for extensively drug-resistant TB (XDR-TB) or treatment-intolerant/non-responsive multidrug-resistant TB (MDR-TB).
Pretomanid works through a dual mechanism of action. Under aerobic (oxygen-rich) conditions, it inhibits the production of mycolic acids – essential components of the mycobacterial cell wall. Under anaerobic (oxygen-poor) conditions, such as those found in TB lesions, it generates reactive nitrogen species that poison the bacterial respiratory system. This dual activity allows pretomanid to kill both actively growing and dormant (non-replicating) TB bacteria, which is critical for achieving a lasting cure.
The introduction of Dovprela-containing regimens has transformed the treatment of drug-resistant TB. Previous treatments for XDR-TB often lasted 18 to 24 months, required painful daily injections, involved up to eight different medications, and achieved cure rates of only 34–50%. The BPaL regimen, by contrast, is entirely oral, lasts only 26 weeks, and has demonstrated cure rates of approximately 89–93% in clinical trials such as the TB-PRACTECAL and ZeNix studies.
What Should You Know Before Taking Dovprela?
Contraindications
Do not take Dovprela if you are allergic to pretomanid, to antibiotics in the nitroimidazole class, or to any of the other ingredients in the medicine (listed in the composition section below). Since pretomanid must always be used in combination with other TB medicines, you should also read the contraindications in the package leaflets of bedaquiline, linezolid, and moxifloxacin. If you are uncertain about any of the information, speak to your doctor or pharmacist.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Dovprela if you:
- Have impaired liver function or liver disease
- Regularly consume alcohol
- Have impaired kidney function
- Have or have had heart rhythm disorders (arrhythmias) or heart failure, or if anyone in your family has heart rhythm problems
- Have an underactive thyroid gland (hypothyroidism)
- Have decreased levels of calcium, magnesium, or potassium in the blood
There is a risk of liver damage (hepatotoxicity) when treated with Dovprela in combination with other TB medicines. Your doctor will monitor you for signs of liver damage and perform blood tests before you start treatment and regularly during treatment. Tell your doctor immediately if you experience fatigue, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, or abdominal pain. Your doctor will adjust treatment if your liver is affected.
Treatment with Dovprela in combination with other TB medicines can cause a significant reduction in blood cell counts, including platelets, red blood cells, and neutrophils (a type of white blood cell). Contact your doctor immediately if you notice signs of bruising, bleeding, or infection. Your doctor will perform a complete blood count before treatment begins and regularly during treatment, adjusting therapy as needed.
Nerve damage in the hands, feet, or eyes can occur during treatment. Contact your doctor if you experience vision problems, or numbness, tingling, or a burning sensation in your hands or feet. In such cases, your doctor will adjust treatment. If you have vision problems, seek an eye examination as soon as possible. Optic neuropathy, including optic disc swelling and cataracts, have been reported.
Increased levels of lactic acid in the blood (lactic acidosis) can occur during treatment. Contact your doctor if you experience recurrent nausea or vomiting. Your doctor may adjust your treatment accordingly.
A certain type of heart rhythm disturbance called QT prolongation may occur during treatment. Your doctor will perform an ECG before treatment starts and regularly throughout treatment. Treatment will be adjusted if heart rhythm disturbances develop. Potassium, calcium, and magnesium levels will also be monitored and corrected if abnormal.
The safety and efficacy of Dovprela in combination with medicines other than linezolid, bedaquiline, and moxifloxacin have not been studied. Dovprela should therefore not be used as part of any other treatment combination.
Children and adolescents: This medicine is not recommended for children or adolescents under 18 years of age, as it has not been studied in this age group.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy: Experience with Dovprela in pregnant women is very limited. Dovprela should only be used during pregnancy if the benefit to the patient outweighs the potential risk to the foetus. Your doctor will determine whether it is appropriate for you to be treated with Dovprela.
Breastfeeding: It is not known whether pretomanid is excreted in breast milk. Your doctor must decide whether you should discontinue breastfeeding or discontinue treatment with Dovprela, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Driving and operating machinery: You may feel dizzy after taking Dovprela, or you may experience vision problems. If you experience either of these effects, do not drive or operate machinery.
Excipients: Dovprela contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine also contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially “sodium-free”.
How Does Dovprela Interact with Other Drugs?
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies. Some medicines can affect how Dovprela works, or Dovprela may affect how other medicines work. Your doctor needs a complete list of all your current medications to prevent dangerous interactions.
Major Interactions – Avoid Concurrent Use
The following medicines can significantly reduce the effectiveness of Dovprela by increasing its metabolism, potentially causing treatment failure. You should inform your doctor immediately if you are taking any of these:
| Drug | Category | Interaction Effect |
|---|---|---|
| Rifampicin, Rifamycin, Rifapentine, Rifabutin | Anti-tuberculosis agents | Strong CYP3A4 induction; markedly reduces pretomanid levels, leading to treatment failure |
| Efavirenz, Etravirine | Antiretroviral agents (HIV) | CYP3A4 induction; decreases pretomanid exposure significantly |
| Carbamazepine, Phenytoin | Antiepileptic drugs | Strong CYP3A4 induction; reduces pretomanid plasma concentrations |
| St. John's Wort (Hypericum perforatum) | Herbal remedy | CYP3A4 induction; may reduce pretomanid effectiveness |
| Hepatotoxic drugs (other than BPaL/BPaLM components) | Various | Increased risk of additive liver damage; speak to your doctor about which drugs this includes |
| Alcohol | Substance | Significantly increases the risk of severe hepatotoxicity; must be avoided throughout treatment |
Other Notable Interactions – Inform Your Doctor
The following medicines may interact with Dovprela in clinically meaningful ways. Your doctor should be informed if you are using any of these:
| Drug | Used For | Interaction Detail |
|---|---|---|
| Methotrexate | Severe arthritis, cancer, psoriasis | Potential for increased toxicity; dose adjustment may be needed |
| Benzylpenicillin, Ciprofloxacin | Bacterial infections | Possible pharmacokinetic interaction; monitoring recommended |
| Indomethacin | Pain and inflammation | May affect pretomanid elimination; monitoring recommended |
| Ritonavir | HIV infection | CYP3A4 inhibition; may increase pretomanid exposure |
What Is the Correct Dosage of Dovprela?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dovprela must always be used in combination with its companion medicines; never take it alone.
Adults (18 Years and Older)
Dovprela is used exclusively in combination regimens. The recommended dosing schedule for the full regimen is as follows:
BPaLM Regimen (4-Drug Combination)
- Dovprela (pretomanid): 200 mg (1 tablet) once daily for 26 weeks
- Bedaquiline: 400 mg once daily for the first 2 weeks, then 200 mg three times per week (with at least 48 hours between doses, e.g. Monday, Wednesday, Friday) for weeks 3–26
- Linezolid: 600 mg once daily for 26 weeks
- Moxifloxacin: 400 mg once daily for 26 weeks
BPaL Regimen (3-Drug Combination – for XDR-TB)
- Dovprela (pretomanid): 200 mg (1 tablet) once daily for 26 weeks
- Bedaquiline: 400 mg once daily for the first 2 weeks, then 200 mg three times per week for weeks 3–26
- Linezolid: 600 mg once daily for 26 weeks
How to take Dovprela: Take Dovprela at the same time as linezolid, bedaquiline, and moxifloxacin (if applicable). Swallow the tablets with a glass of water, together with food. If you have difficulty swallowing a whole tablet, an acceptable alternative is to crush the tablets and mix them with water for ingestion. The mixture should be taken immediately after crushing and mixing.
Treatment is administered under directly observed therapy (DOT) by healthcare professionals or in accordance with local regulations. This ensures that every dose is taken correctly, which is critical for preventing the development of further antibiotic resistance.
Treatment duration: The treatment course for Dovprela in combination with other TB medicines is 26 weeks. Your doctor may decide to extend or discontinue this period to ensure that the treatment is safe and effective for you. Blood tests, ECGs, and clinical assessments are performed at regular intervals throughout the treatment course.
Children and Adolescents
Dovprela is not recommended for use in children or adolescents under 18 years of age. This is because it has not been studied in this age group. Clinical trials evaluating the safety and pharmacokinetics of pretomanid in paediatric populations are ongoing, and guidelines may be updated as new data become available.
Elderly Patients
No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients are more likely to have reduced liver or kidney function, cardiac comorbidities, or to be taking multiple medications that may interact with Dovprela. Your doctor will consider these factors and may monitor you more closely during treatment.
Missed Dose
Do not take a double dose to make up for a forgotten dose. It is recommended that missed doses of pretomanid, bedaquiline, or moxifloxacin be made up at the end of treatment by extending the treatment duration. It is not recommended to make up for doses of linezolid missed due to side effects. Talk to your doctor or pharmacist if you have missed a dose and are unsure of what to do.
Overdose
If you have taken more Dovprela than you should, seek medical attention immediately and bring the medicine packaging with you. There is no specific antidote for pretomanid overdose; treatment is supportive and symptomatic. Given the risk of QT prolongation, cardiac monitoring may be indicated in cases of significant overdose.
Do not stop taking Dovprela or its companion medicines (linezolid, bedaquiline, or moxifloxacin) without your doctor's permission. Skipping doses or not completing the full treatment course can make the treatment ineffective and the tuberculosis may worsen. This would also increase the risk of the bacteria developing resistance to these medicines, which are often the last available treatment options.
What Are the Side Effects of Dovprela?
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below have been reported when Dovprela was used together with other TB medicines as part of the BPaL and BPaLM regimens. Many of these effects are attributable to the companion drugs (particularly linezolid) rather than to pretomanid alone.
- Signs of liver damage: fatigue, loss of appetite, nausea, yellowing of skin or eyes, dark urine, abdominal pain
- Signs of low blood counts: unusual bruising or bleeding, frequent infections, extreme fatigue or weakness
- Signs of lactic acidosis: recurrent nausea or vomiting
- Signs of nerve damage: numbness, tingling, or burning in hands or feet; vision changes
- Signs of angioedema: swelling of face, lips, tongue, or eyes
Very Common
May affect more than 1 in 10 people
- Anaemia (decreased red blood cells) – causing fatigue, weakness, shortness of breath
- Decreased white blood cells (leukopenia) – increased risk of infections
- Elevated liver enzymes (transaminases: ALT, AST)
- Nausea and vomiting
- Rash
- Headache
- Musculoskeletal pain (joint pain, back pain, muscle pain)
- Peripheral neuropathy (numbness, tingling, burning in hands or feet)
- QT prolongation on ECG (abnormal heart electrical activity)
Common
May affect up to 1 in 10 people
- Decreased platelets or white blood cells (thrombocytopenia, neutropenia)
- Elevated gamma-glutamyltransferase (GGT)
- Elevated blood lactic acid levels (lactic acidosis)
- Fungal infections (oral or vaginal candidiasis)
- Insomnia, depression
- Fatigue, decreased appetite, taste changes
- Dizziness, tremor, muscle cramps
- Diarrhoea, constipation, indigestion, gastritis, pancreatitis, abdominal pain
- Dry skin, pruritus (itching), urticaria (hives), acne
- Vision problems, hearing loss
- Palpitations, chest pain, hypertension
- Haemoptysis (coughing up blood), epistaxis (nosebleeds)
- Elevated bilirubin, amylase, lipase, alkaline phosphatase, creatinine, blood glucose, blood urea nitrogen
- Changes in blood electrolytes (sodium, potassium, calcium, magnesium levels)
Uncommon
May affect up to 1 in 100 people
- Angioedema (swelling of face, lips, tongue, or eyes)
- Dehydration, decreased body fluid volume
- Anxiety
- Enlarged liver, jaundice (yellowing of skin and eyes)
- Cataract (clouding of the eye lens), presbyopia (difficulty seeing close objects)
- Eye irritation, itching, swelling, or pain
- Optic nerve damage and/or inflammation with visual disturbances
- Papilloedema (optic disc swelling leading to vision loss)
- Increased or decreased heart rate, low blood pressure
- Cough, abdominal bloating, belching, burning tongue
- Gastro-oesophageal reflux, arthritis (joint swelling and pain)
- Allergic reaction, eczema, hyperpigmentation, hair loss
- Pancytopenia (deficiency of all blood cell types)
- Elevated creatine phosphokinase, uric acid
If you experience any side effects, including any not listed above, talk to your doctor, pharmacist, or nurse. Reporting suspected side effects helps with the continuous monitoring of the benefit-risk balance of medicines. You can report side effects to your national medicines regulatory authority.
How Should You Store Dovprela?
Keep this medicine out of the sight and reach of children at all times. Do not use this medicine after the expiry date which is stated on the carton, bottle, or blister after “EXP”. The expiry date refers to the last day of the stated month.
No special storage conditions are required for Dovprela. It does not need to be refrigerated and can be stored at room temperature. Keep the tablets in their original packaging to protect them from moisture and light until you are ready to take them.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment and prevent accidental exposure.
What Does Dovprela Contain?
Active substance: Pretomanid. Each tablet contains 200 mg of pretomanid.
Other ingredients (excipients): Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulphate, and povidone.
Appearance: Dovprela is a white to off-white, oval tablet debossed with “M” on one side and “P200” on the other side. Tablet dimensions: 18 × 9 mm.
Available pack sizes:
- Blister packs containing 14, 14 × 1, 182, or 182 × 1 tablets
- Plastic bottles containing 26 tablets
Not all pack sizes may be marketed in your country.
Marketing authorisation holder: Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland (part of the Viatris group).
Frequently Asked Questions About Dovprela
BPaL stands for Bedaquiline, Pretomanid (Dovprela), and Linezolid. It is a groundbreaking all-oral, 26-week treatment regimen for extensively drug-resistant tuberculosis (XDR-TB) and treatment-intolerant or non-responsive multidrug-resistant TB. Before BPaL, patients with XDR-TB faced treatments lasting 18–24 months involving daily injections (such as kanamycin or amikacin), multiple oral medications, and cure rates of only 34–50%. The BPaL regimen has demonstrated cure rates of approximately 89–93% in clinical trials, transforming the outlook for patients with the most difficult-to-treat forms of TB. The WHO now conditionally recommends BPaL and BPaLM (which adds moxifloxacin) as preferred regimens.
No. Alcohol must be completely avoided during the entire course of treatment with Dovprela. Both pretomanid and its companion drugs (particularly bedaquiline and linezolid) carry a risk of liver toxicity. Alcohol significantly amplifies this risk and can lead to serious, potentially life-threatening liver damage. Your doctor will monitor your liver function with blood tests throughout treatment, but avoiding alcohol is essential to minimise the risk of hepatotoxicity.
Extensive monitoring is required throughout the 26-week treatment course. This includes: Liver function tests (ALT, AST, bilirubin) before treatment and at regular intervals; Complete blood count (haemoglobin, white blood cells, platelets, neutrophils) before and during treatment; ECG (electrocardiogram) to monitor for QT prolongation before and during treatment; Electrolyte levels (potassium, calcium, magnesium) to correct any abnormalities; Visual acuity and eye examinations to detect optic neuropathy; and Clinical assessment for symptoms of peripheral neuropathy, lactic acidosis, and hepatotoxicity. The frequency of monitoring is typically monthly but may be more frequent if abnormalities are detected.
This is an important consideration, as TB and HIV co-infection is common globally. Certain HIV medications, particularly efavirenz and etravirine, are strong CYP3A4 inducers that significantly reduce pretomanid levels and must be avoided. However, other antiretroviral agents may be compatible. Ritonavir (a CYP3A4 inhibitor) may increase pretomanid levels and requires monitoring. Your infectious disease specialist will carefully select an antiretroviral regimen that is compatible with the BPaL or BPaLM treatment. Dolutegravir-based antiretroviral regimens are generally considered compatible with the BPaL regimen.
Clinical trial data have demonstrated impressive efficacy. The Nix-TB trial, the first pivotal study of BPaL, showed a treatment success rate of approximately 90% in patients with XDR-TB or treatment-intolerant/non-responsive MDR-TB at 6 months post-treatment. The ZeNix trial further confirmed these results while optimising the linezolid dose. The TB-PRACTECAL trial demonstrated that BPaLM achieved a treatment success rate of approximately 89% at 72 weeks. These results are remarkable given that previous standard-of-care regimens for XDR-TB achieved cure rates of only 34–50% with significantly longer and more toxic treatment courses.
Linezolid is the component of the BPaL/BPaLM regimen most commonly responsible for side effects, particularly peripheral neuropathy, myelosuppression (low blood counts), and lactic acidosis. If you experience these effects, do not stop any of your medicines on your own. Contact your doctor, who may reduce the dose of linezolid (from 600 mg to 300 mg daily), temporarily interrupt linezolid, or manage the side effects with supportive care. The ZeNix trial demonstrated that a lower starting dose of linezolid (600 mg daily) with dose modification as needed maintained efficacy while improving tolerability. Missed linezolid doses due to side effects do not need to be made up at the end of treatment.
References
This article is based on the following peer-reviewed sources and international guidelines:
- World Health Organization (WHO). WHO consolidated guidelines on tuberculosis. Module 4: treatment – drug-resistant tuberculosis treatment, 2022 update. Geneva: WHO; 2022.
- European Medicines Agency (EMA). Dovprela (pretomanid) – Summary of Product Characteristics. Amsterdam: EMA; 2024.
- Conradie F, Diacon AH, Ngubane N, et al. Treatment of Highly Drug-Resistant Pulmonary Tuberculosis. New England Journal of Medicine. 2020;382(10):893–902. doi: 10.1056/NEJMoa1901814 (Nix-TB trial)
- Conradie F, Bagdasaryan TR, Borisov S, et al. Bedaquiline–Pretomanid–Linezolid Regimens for Drug-Resistant Tuberculosis. New England Journal of Medicine. 2022;387(9):810–823. doi: 10.1056/NEJMoa2119430 (ZeNix trial)
- Nyang'wa BT, Berry C, et al. A randomised controlled trial of the BPaLM regimen for drug-resistant tuberculosis (TB-PRACTECAL). New England Journal of Medicine. 2023;388(1):18–30. doi: 10.1056/NEJMoa2212485
- US Food and Drug Administration (FDA). Pretomanid Tablets – Prescribing Information. Silver Spring, MD: FDA; 2019.
- WHO. Global Tuberculosis Report 2024. Geneva: World Health Organization; 2024.
Editorial Team
This article was prepared by the iMedic Medical Editorial Team with expertise in infectious diseases and clinical pharmacology. All content has been reviewed according to international medical standards and the GRADE evidence framework.
Reviewed by board-certified specialists in infectious diseases and pulmonology with expertise in drug-resistant tuberculosis management.
Based on WHO consolidated guidelines, EMA assessment reports, FDA prescribing information, and peer-reviewed clinical trial data (Level 1A evidence).
Conflict of interest declaration: iMedic receives no commercial funding or pharmaceutical company sponsorship. All editorial content is independent and evidence-based.
Last medical review: