- 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 do not differ from adult values (SmPC):
| Dose | Cmax (mg/l) | Tmax (hour) | t½ (hour) | Cl (l/hour) | Vd (l) | |
| Tezacaftor | 100 mg/day | 6.5 ± 1.8 | 4 (2-6) | 156 ± 52.7 | 1.3 ± 0.4 | 271 ± 157 |
| Ivacaftor | 300 mg/day | 1.3 ± 0.4 | 6 (3-10) | 9.3 ± 1.7 | 15.7 ± 6.4 | 206 ± 82.9 |
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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
Note: The dose should be adjusted when tezacaftor + ivacaftor is used in combination with Cyp3A4 inhibitor drugs or in case of hepatic impairment (see SmPC)
Dosages
| Cystic fibrosis |
|---|
|
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Renal impaiment in children > 3 months
Ivacaftor: dose adjustment not needed.
Tezacaftor:
GFR ≥ 30 ml/min/1.73m2: dose adjustment not needed
GFR 10 - 30 ml/min/1.73m2: dose adjustment probably not needed. Consultation with paediatric nephrologist indicated.
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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
Ivacaftor: cloudiness of the eye lens
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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 during treatment, as cases of cloudiness of the eye lens have been reported.
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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 | ||
| R07AX30 | ||
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Reference
- Vertex Pharmaceuticals (Ireland) Limited, SmPC Symkevi (EU/1/18/1306) Rev 7, 22-01-2021, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
