Tezacaftor + ivacaftor
Generic name
Tezacaftor + ivacaftor
Brand name
ATC Code
R07AX31
- 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 |
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
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 |
|---|
|
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.
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
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.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
OTHER RESPIRATORY SYSTEM PRODUCTS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Lung surfactants | ||
|---|---|---|
| R07AA02 | ||
| R07AA05 | ||
| Respiratory stimulants | ||
|---|---|---|
| R07AB01 | ||
| Other respiratory system products | ||
|---|---|---|
| R07AX02 | ||
| R07AX32 | ||
| R07AX30 | ||
Reference
- Vertex Pharmaceuticals (Ireland) Limited, SmPC Symkevi (EU/1/18/1306) Rev 7, 22-01-2021, www.geneesmiddeleninformatiebank.nl
Changes
Therapeutic Drug Monitoring
Overdose
