Antituberculous Agents — MDR-TB Pregnancy: Avoid if possible — limited data; animal studies show no evidence of teratogenicity; use only if clearly necessary and no alternative for MDR-TB; consult specialist

Delamanid

Brand names: Deltyba

Adult dose

Dose: 100 mg twice daily for 24 weeks

Route: Oral

Frequency: Twice daily with food

Max: 200 mg/day

Take with food (meal with at least 380 calories — increases absorption 2.7-fold). Under directly observed therapy. Must be given with optimised background regimen. ECG monitoring mandatory.

Paediatric dose

Dose: Under 20 kg: 25 mg twice daily; 20–34 kg: 50 mg twice daily; 35 kg and above: 100 mg twice daily mg/dose/kg

Route: Oral

Frequency: Twice daily

Max: 100 mg twice daily

Licensed from age 3 years for MDR-TB; paediatric granules formulation available; seek specialist paediatric TB opinion at national centre

Dose adjustments

Renal

No dose adjustment for mild-moderate impairment; avoid in severe renal impairment — limited data

Hepatic

No dose adjustment in mild impairment; avoid in moderate-severe hepatic impairment — significant increase in QT-prolonging metabolites

Paediatric weight-based calculator

Patient weight (kg)

Licensed from age 3 years for MDR-TB; paediatric granules formulation available; seek specialist paediatric TB opinion at national centre

Clinical pearls

Mechanism: nitroimidazole prodrug — activated by mycobacterial F420-dependent nitroreductase; inhibits synthesis of mycobacterial cell wall component methoxy-mycolic acid and keto-mycolic acid; unique target distinct from other TB drugs
DEJAVU and DLDE trials: delamanid added to optimised background regimen in MDR-TB — significant increase in sputum culture conversion at 2 months (45% vs 29%); 6-month data showed improved treatment outcomes
WHO 2022: delamanid is a group B drug in MDR-TB WHO classification — used in longer MDR-TB regimens when bedaquiline cannot be used or as add-on; BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) preferred if susceptible
QTc MONITORING: baseline ECG mandatory; repeat at 2, 4, 8, and 12 weeks then monthly; correct electrolytes before starting; if QTc above 450 ms, more frequent monitoring; stop if QTc above 500 ms
ALBUMIN MONITORING: hypoalbuminaemia (below 28 g/L) increases free delamanid concentrations — check albumin at baseline and monthly; nutritional support to maintain albumin above 28 g/L
MHRA: licensed for MDR-TB (pulmonary) in adults and children from age 3; must be notified to PHE/UKHSA; prescribing limited to specialist TB centres

Contraindications

Severe hepatic impairment (metabolite accumulation increases QTc risk)
Hypoalbuminaemia (below 28 g/L — increases free drug and QTc risk)
Baseline QTc above 500 ms
Known hypersensitivity to delamanid or nitroimidazoles

Side effects

QT prolongation (dose-dependent — mean increase 12.1 ms; greater with concurrent QT-prolonging drugs)
Insomnia
Anxiety, paraesthesias (CNS effects — nitroimidazole class)
Nausea
Hypoalbuminaemia (can worsen QTc risk)

Interactions

Bedaquiline (additive QTc prolongation — weekly ECG if co-prescribed; evidence supports combination in XDR-TB)
CYP3A4 inducers (lopinavir/ritonavir — increases delamanid metabolite by 2-fold; monitor ECG closely)
Other QT-prolonging drugs (additive — monitor ECG monthly at minimum)
Rifampicin (CYP3A4 inducer — reduces delamanid exposure; avoid combination in MDR-TB regimens where rifampicin is not active)

Monitoring

ECG (baseline, 2, 4, 8, 12 weeks then monthly — QTc)
Serum albumin (monthly — hypoalbuminaemia increases QTc risk)
Electrolytes (K+, Mg2+, Ca2+ — correction before starting)
LFTs (monthly)
Monthly sputum smear and culture

Reference: BNFc; BNF 90; NICE NG33; WHO TB Guidelines 2022; DEJAVU trial Lancet 2012;379(9832):2065-2075; MHRA SPC Deltyba. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Drugs

Bedaquiline · Antituberculous Agents — MDR-TB

Pathways