- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
F = 55%
T½: 2-6 hours
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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
| Duchenne muscular dystrophy in outpatients |
|---|
|
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Renal impaiment in children > 3 months
- GFR ≥30: dose adjustment not needed
- GFR 10-30: general advice cannot be given; consider whether the intended effect of ataluren outweighs the potential risks
- GFR <10: general advice cannot be given; consider whether intended effect of ataluren outweighs possible risks
Clinical consequences
With impaired renal function, exposure to ataluren and the acylglucuronide metabolite increases. This increases the risk of adverse reactions.
Clinical effects:
The toxicity of the metabolite is not known. In a study with 1-mal ataluren, the exposure ataluren in subjects with ClCr <30 ml/min was 61% higher compared to subjects with normal renal function. The exposure acylglucuronide metabolite was 3-8x higher.
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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
The side effect profile in children matches that of adults.
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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
No information available on specific warnings and precautions in children.
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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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| Other drugs for disorders of the musculo-skeletal system | ||
|---|---|---|
| M09AX07 | ||
| M09AX09 | ||
| M09AX10 | ||
| M09AX09 | ||
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References
- PTC Therapeutics International Limited, SmPC Translarna (EU/1/13/902/003) 31-08-2018, www.geneesmiddeleninformatiebank
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
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Changes
Changes
