- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
In adolescents weighing between 30 and 40 kg, average exposure is predicted to be higher compared to adult patients. [SmPC]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Multi-drug resistant tuberculosis |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Based on limited study data (n=15), there is no evidence of any difference in the safety profile in adolescents compared to adults.
In paediatric patients aged 5 years to less than 11 years (N=15), the most common adverse reactions were related to elevations in liver enzymes (5/15, 33%), reported as ALT/AST increased and hepatotoxicity; hepatotoxicity led to discontinuation of Bedaquiline in three patients. Elevations in liver enzymes were reversible upon discontinuation of Bedaquiline and background regimen.
In paediatric patients aged 2 years to less than 5 years (N=15), the most common adverse reaction was vomiting in 3/15 (20%) patients. QT prolongation and arthralgia were reported in one patient each.
[SmPC Sirturo]
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
In adolescents weighing between 30 and 40 kg, the average exposure is expected to be higher than in adult patients. This may be associated with an increased risk of QT prolongation or hepatotoxicity.
Administration together with food increases the bioavailability by a factor 2.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antibiotics | ||
|---|---|---|
| J04AB04 | ||
| J04AB02 | ||
| Hydrazides | ||
|---|---|---|
| J04AC01 | ||
| Other drugs for treatment of tuberculosis | ||
|---|---|---|
| J04AK06 | ||
| J04AK02 | ||
| J04AK01 | ||
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References
- Janssen-Cilag International NV, SmPC Sirturo (EU/1/13/901/001-002) Rev 20. 13-07-2021, www.geneesmiddeleninformatiebank.nl
- Janssen-Cilag International NV, SmPC Sirturo (EU/1/13/901/001-002) Rev 23; 24-11-2025, www.ema.europa.eu
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Changes
Changes
