Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Otsuka Novel Products GmbH, Erika-Mann-Straße 21, 80636 München, Germany
Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4.2, 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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 sections 4.4 and 5.1). 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).
For adult patients the use of film-coated tablets is recommended, please see the SmPC for Deltyba 50 mg film-coated tablets.
Paediatric patients with a body weight of
For patients with a body weight of 30 kg or more please see the SmPC for Deltyba 50 mg film-coated tablets.
No data are available in the elderly. For adult patients please see the SmPC for Deltyba 50 mg filmcoated tablets.
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 sections 4.4 and 5.2).
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 sections 4.4 and 5.2).
The safety and efficacy of Deltyba in children with a body weight below 10 kg have not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Oral use.
Delamanid should be taken with food.
The dispersible tablets must be dispersed in water using 10 to 15 ml per 25 mg dispersible tablet and the resulting whitish suspension must be ingested immediately. Thereafter further 10 to 15 ml of water per dispersible tablet must be added to the glass or cup to ensure that potentially remaining suspension is dispersed and the resulting suspension must also be ingested.
No cases of delamanid overdose have been observed in clinical trials. However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily. Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner. Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required. Frequent ECG monitoring should be performed.
3 years.
Store in the original package in order to protect from moisture and light.
Aluminium/Aluminium blister: 48 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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