- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Predicted exposure (AUC) based on simulations is almost twice as high in patients above 12 months (> 7 kg) compared to children aged 1 month to 12 months (< 7 kg) [SmPC Kalydeco]
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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
When co-administered with moderate or strong CYP3A4 inhibitors, the dose of ivacaftor should be adjusted, see SmPC
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
Very common: Nasopharyngitis, infection of the upper respiratory tract, rhinitis, headaches, dizziness, blocked nose, oropharyngeal pain, abdominal pain, diarrhoea, rash, bacteria in the sputum. transaminase elevations
Common: Earache, tympanic membrane hyperaemia, tinnitus, pharyngeal erythema, sinus congestion, chest masses.
Seldom: blocked ear, inflammation of the breast, gynaecomastia, nipple disorder, pain in the nipple.
Cloudiness of the eye lens has been reported in children
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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
The daily dose should be halved in moderately impaired hepatic function (Child-Pugh class B).
Take with foods that contain fat. Meals and snacks that are recommended in the CF guidelines or meals in the standard nutrition guidelines contain enough fat.
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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 | ||
|---|---|---|
| R07AX32 | ||
| R07AX30 | ||
| R07AX31 | ||
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Reference
- Vertex Pharmaceuticals (U.K.) Limited, SmPC Kalydeco (EU/1/12/782/001-004) Rev 43 16-09-2024, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
