- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of delamanid.
For use as part of a combination regimen for pulmonary multi-drug resistant tuberculosis when an effective regimen cannot otherwise be given due to resistance or tolerability.
Delamanid must only be used in an appropriate combination regimen for multidrug-resistant tuberculosis treatment as recommended by WHO to prevent development of resistance to delamanid.
It is recommended that delamanid is administered by directly observed therapy (DOT).
Pulmonary multidrug-resistant tuberculosis
100mg twice daily for 24 weeks.
Body weight 50kg and over: 100mg twice daily for 24 weeks.
Body weight 30 to 50kg: 50mg twice daily for 24 weeks.
Children weighing less than 10kg
Serum albumin less than 2.8g/dL
Long QT syndrome
Moderate hepatic impairment
QTc interval greater than or equal to 500 msec
Severe renal impairment
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
Patients over 65 years
Serum albumin 2.8g/dL - 3.4g/dL
Congestive cardiac failure with reduced left ventricular ejection fraction
History of cardiac arrhythmias
History of left ventricular hypertrophy
History of torsade de pointes
QTc interval greater than 450 milliseconds in males
QTc interval greater than 470 milliseconds in female adults
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Must be used in combination with other anti-tuberculous drugs
Treatment to be initiated and supervised by a specialist
Advise patient to take with or after food
Professional and patient should be aware that this is an unlicensed product
Perform ECG before and during treatment
Monitor serum albumin
Monitor serum electrolytes
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Advise patient to seek advice at first indications of pregnancy
Discontinue treatment if QTc exceeds 500msec
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
The manufacturer suggests that ECGs should be obtained prior to initiating treatment and monthly during the course of treatment. If the QTc interval exceeds 450 milliseconds in males or 470 milliseconds in females during delamanid treatment, more frequent ECG monitoring is required.
Treatment initiated in patients with albumin ranging from 2.8 to 3.4 g/dL, or patients who experience a fall in serum albumin into this range during delamanid treatment should receive very frequent monitoring of ECGs throughout the full treatment period.
Patients also taking CYP3A4 inhibitors, quinolones or other medicinal products know to prolong the QTc interval during delamanid treatment should also receive very frequent monitoring of ECGs throughout the full treatment period.
Pregnancy and Lactation
Delamanid is contraindicated during pregnancy.
The manufacturer does not recommend using delamanid during pregnancy or in women of childbearing potential unless they are using a reliable form of contraception.
At the time of writing, there are limited data from the use of delamanid in pregnant women. Studies in animals have shown reproductive toxicity.
Delamanid is contraindicated during breastfeeding.
The manufacturer suggests women should not breastfeed during treatment with delamanid because a potential risk to the breastfed infant cannot be ruled out.
At the time of writing, it is unknown if delamanid or its metabolites are excreted in human breast milk. Available data in animals have shown excretion of delamanid and/or its metabolites in milk.
Blood pressure changes
Dryness and irritation of throat
Eosinophilic pustular folliculitis
First degree AV block
Gamma glutamyl transferase (GGT) increased
Increase in serum transaminases
Increased partial thromboplastin time
Loss of balance
Prolongation of QT interval
Reduction in serum cortisol levels
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2020
Summary of Product Characteristics: Deltyba 50 mg film-coated tablets. Otsuka GmbH. Revised April 2020.
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.