Deltyba Dosage/Direction for Use

Treatment with delamanid should be initiated and monitored by a physician experienced in the management of multidrug-resistant Mycobacterium tuberculosis.
Delamanid must always be administered as part of an appropriate combination regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB) (see Precautions and Pharmacology: Pharmacodynamics under Actions). Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
It is recommended that delamanid is administered by directly observed therapy (DOT).
Posology: Adults: The recommended dose for adults is 100 mg twice daily for 24 weeks.
Adolescents and children: Paediatric patients with a body weight of ≥30 to <50 kg: the recommended dose is 50 mg twice daily for 24 weeks.
≥50 kg: the recommended dose is 100 mg twice daily for 24 weeks.
Elderly patients (>65 years of age): No data are available in the elderly.
Renal impairment: No dose adjustment is considered necessary in patients with mild or moderate renal impairment. There are no data on the use of delamanid in patients with severe renal impairment and its use is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is considered necessary in patients with mild hepatic impairment. Delamanid is not recommended in patients with moderate to severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of delamanid 50 mg film-coated tablets in children with a body weight of less than 30 kg have not yet been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Oral use.
Delamanid should be taken with food.