Delamanid


Generic Medicine Info
Indications and Dosage
Oral
Pulmonary multidrug-resistant tuberculosis
Adult: 100 mg bid for 24 weeks as part of an appropriate combination regimen. Consider local guidelines on the appropriate use of anti-tuberculosis drugs.
Child: As 25 mg dispersible tab: For patients weighing 10-<20 kg: 25 mg bid; 20-<30 kg: 50 mg in the morning and 35 mg in the evening. As 50 mg film-coated tab: For patients weighing 30-<50 kg: 50 mg bid; ≥50 kg: 100 mg bid. All doses should be given for 24 weeks as part of an appropriate combination regimen. Dosage recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
What are the brands available for Delamanid in Hong Kong?
Renal Impairment
Severe: Not recommended.
Hepatic Impairment
Moderate to severe: Not recommended.
Administration
Delamanid film-coated tab: Should be taken with food.
Contraindications
Hypersensitivity. Serum albumin <2.8 g/dL. Concurrent use with strong CYP3A4 inducers (e.g. carbamazepine).
Special Precautions
Patient with risk factors for QT interval prolongation such as congenital long QT syndrome, history of symptomatic cardiac arrhythmias, clinically significant bradycardia, severe hypertension, left ventricular hypertrophy including hypertrophic cardiomyopathy, heart failure with reduced left ventricular ejection fraction, electrolyte disturbances (particularly hypocalcaemia, hypokalaemia, or hypomagnesaemia); serum albumin <3.4 g/dL or those who experience serum albumin reduction into this range during treatment. Patient taking other agents known to prolong QT interval (e.g. antiarrhythmic agents, neuroleptics, non-sedating antihistamines, antimalarials, macrolides). Do not initiate treatment if the baseline QT interval is >500 milliseconds. Hepatic and severe renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: QT interval prolongation.
Cardiac disorders: Chest pain, palpitations, 1st-degree AV block, ventricular extrasystoles.
Endocrine disorders: Hypothyroidism.
Gastrointestinal disorders: Nausea, vomiting, gastritis, dyspepsia.
General disorders and administration site conditions: Asthenia, paradoxical drug reaction.
Investigations: Increased cortisol.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Muscular weakness, muscle spasms.
Nervous system disorders: Dizziness, headache, tremor, hypoaesthesia.
Psychiatric disorders: Insomnia, nightmares, anxiety, depression, hallucination.
Respiratory, thoracic and mediastinal disorders: Throat irritation.
Patient Counseling Information
This drug may cause headache or tremor, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Obtain ECG before treatment initiation, monthly, and/or as clinically indicated. Monitor serum electrolytes and albumin at baseline and periodically.
Drug Interactions
Strong CYP3A4 inducers (e.g. carbamazepine) may reduce the serum concentration of delamanid. Increased risk of QT interval prolongation with strong CYP3A4 inhibitors (e.g. ritonavir, lopinavir), antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol), neuroleptics (e.g. phenothiazines, chlorpromazine, haloperidol, pimozide, thioridazine), antidepressants, antimicrobial agents (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin), triazole antifungal agents, non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine); antimalarials (e.g. halofantrine, quinine, chloroquine), cisapride, droperidol, domperidone, probucol, methadone, vinca alkaloids, and arsenic trioxide.
Food Interaction
Increased bioavailability with food.
Action
Description:
Mechanism of Action: Delamanid, a nitroimidazole-oxazole antimycobacterial agent, is a prodrug activated by Mycobacterium tuberculosis through the bioreduction of its nitro group. It suppresses the synthesis of mycobacterial cell wall components, methoxymycolic and ketomycolic acids.
Pharmacokinetics:
Absorption: Increased bioavailability with food.
Distribution: Widely distributed throughout the body. Plasma protein binding: ≥99.5%.
Metabolism: Mainly metabolised in the plasma by albumin and, to a lesser extent, by CYP3A4 isoenzyme to form DM-6705.
Excretion: Mainly via faeces; urine (<5%). Elimination half-life: 30-38 hours.
Chemical Structure

Chemical Structure Image
Delamanid

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6480466, Delamanid. https://pubchem.ncbi.nlm.nih.gov/compound/Delamanid. Accessed Mar. 26, 2025.

Storage
Keep in the original package to protect from moisture.
MIMS Class
Anti-TB Agents
ATC Classification
J04AK06 - delamanid ; Belongs to the class of other drugs used in the systemic treatment of tuberculosis.
References
Brayfield A, Cadart C (eds). Delamanid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/12/2024.

Delamanid. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/12/2024.

Deltyba 50 mg Film-coated Tablets (Otsuka Pharmaceuticals [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/12/2024.

Deltyba 50 mg Film-coated Tablets and 25 mg Dispersible Tablets (Otsuka Novel Products GmbH). European Medicines Agency [online]. Accessed 06/12/2024.

Joint Formulary Committee. Delamanid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/12/2024.

Disclaimer: This information is independently developed by MIMS based on Delamanid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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