- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The exposures are similar between adults and the paediatric population based on population (PK) analyses [SmPC Orkambi film-coated tablets]
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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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General Dose Info
Adjust the dose if
- Co-administerred with moderate or strong CYP3A4 inhibitors
- In moderate to severe hepatic failure (Child-Pugh B/C)
see SmPC for recommendations
Dosages
| Cystic fibrosis |
|---|
|
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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
Side effects in children are the same as the side effects in 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 in children
Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with lumacaftor/ivacaftor and ivacaftor monotherapy. Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded. Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with lumacaftor/ivacaftor.
Elevations in transaminases were seen more frequently in children and adolescents than in adult patients. In the various pediatric age cohorts, increases in transaminases were observed more frequently in the 2 to 5 year olds than in the 6 to 11 year olds. [SmPC Orkambi film-coated tablets and granules]
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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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| Lung surfactants | ||
|---|---|---|
| R07AA02 | ||
| R07AA05 | ||
| Respiratory stimulants | ||
|---|---|---|
| R07AB01 | ||
| Other respiratory system products | ||
|---|---|---|
| R07AX02 | ||
| R07AX32 | ||
| R07AX31 | ||
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Reference
- Vertex Pharmaceuticals (Europe) Limited, SmPC Orkambi (EU/1/15/1059) Rev.32. 27-07-2023, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
