- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Pharmacokinetic parameters for children ≥12 years [SmPC Kaftrio]:
| Dose | Cmax (µg/ml) | |
| Elexacaftor | 200 mg/day | 9,15 ± 2,09 |
| Tezacaftor | 100 mg/day | 7,67 ± 1,68 |
| Ivacaftor | 150 mg/2 dd | 1,24 ± 0,34 |
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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
The dose should be adjusted when combined with Cyp3A4 inhibiting drugs or in hepatic impairment (see SmPC)
Dosages
| Cystic fibrosis |
|---|
|
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Renal impaiment in children > 3 months
No dose adjustment is recommended for patients with mild and moderate renal impairment.
[SmPC Kaftrio]
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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 comparable to those observed 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
Cataract: Ophthalmic examinations are recommended in children prior to and dureing treatment, as cases of cloudiness of the eye lens have been reportet [SmPC Kaftrio].
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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 | ||
| R07AX30 | ||
| R07AX31 | ||
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Reference
- Vertex Pharmaceuticals (Ireland) Limited, SmPC Kaftrio (EU/1/20/1468/001) Rev 24. 24-10-2024, www.ema.europa.eu
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Changes
Changes
