- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| 40 mcg/kg/day | 120 mcg/kg/day | |
| Cmax (simulated) | 0,211 ng/ml | 0,623 ng/ml |
| V/F (mean) | 40,3 L/kg | 43,7 L/kg |
| Cl/F | 26,4 L/kg/hour | 23,0 L/kg/hour |
| T1/2 | 2,5 hour | |
Source: SmPC Bylvay
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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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Dosages
| Cholestatic pruritus in Alagille syndrome (ALGS) |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
No information is present at this moment.
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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
No information available on specific warnings and precautions in children.
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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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| Bile acids and derivatives | ||
|---|---|---|
| A05AA02 | ||
| Other drugs for bile therapy | ||
|---|---|---|
| A05AX04 | ||
| BILE ACIDS AND DERIVATIVES | ||
|---|---|---|
| A05AA02 | ||
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References
- Albireo AB, SmPC Bylvay (EU/1/21/1566/001) Rev.3, 5-7-2023, www.ema.europa.eu
- Ipsen Pharma, SmPC Kayfanda (EU/1/24/1854) Rev 3; 08-05-2025, www.ema.europa.eu
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Changes
Changes
