Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
Treatment must be initiated and supervised by physicians experienced in the management of PFIC.
The recommended dose of odevixibat is 40 mcg/kg administered orally once daily in the morning. Odevixibat can be taken with or without food.
Table 1 shows the strength and number of capsules that should be administered daily based on body weight to approximate a 40 mcg/kg/day dose.
Table 1. Number of Bylvay capsules needed to achieve the nominal dose of 40 mcg/kg/day:
| Body weight (kg) | Number of 200 mcg capsules | Number of 400 mcg capsules | |
|---|---|---|---|
| 4 to <7.5 | 1 | or | N/A |
| 7.5 to <12.5 | 2 | or | 1 |
| 12.5 to <17.5 | 3 | or | N/A |
| 17.5 to <25.5 | 4 | or | 2 |
| 25.5 to <35.5 | 6 | or | 3 |
| 35.5 to <45.5 | 8 | or | 4 |
| 45.5 to <55.5 | 10 | or | 5 |
| ≥55.5 | 12 | or | 6 |
Capsule strength/number in bold is recommended based on predicted ease of administration.
Improvement in pruritus and reduction of serum bile acid levels may occur gradually in some patients after initiating odevixibat therapy. If an adequate clinical response has not been achieved after 3 months of continuous therapy, the dose may be increased to 120 mcg/kg/day (see section 4.4).
Table 2 shows the strength and number of capsules that should be administered daily based on body weight to approximate a 120 mcg/kg/day dose, with a maximum daily dose of 7200 mcg per day.
Table 2. Number of Bylvay capsules needed to achieve the nominal dose of 120 mcg/kg/day:
| Body weight (kg) | Number of 600 mcg capsules | Number of 1 200 mcg capsules | |
|---|---|---|---|
| 4 to <7.5 | 1 | or | N/A |
| 7.5 to <12.5 | 2 | or | 1 |
| 12.5 to <17.5 | 3 | or | N/A |
| 17.5 to <25.5 | 4 | or | 2 |
| 25.5 to <35.5 | 6 | or | 3 |
| 35.5 to <45.5 | 8 | or | 4 |
| 45.5 to <55.5 | 10 | or | 5 |
| ≥55.5 | 12 | or | 6 |
Capsule strength/number in bold is recommended based on predicted ease of administration.
Alternative treatment should be considered in patients for whom no treatment benefit can be established following 6 months of continuous daily treatment with odevixibat.
If a dose of odevixibat is missed, the patient should take the forgotten dose as soon as possible without exceeding one dose per day.
No dose adjustment is required for patients with mild or moderate renal impairment.
There are no available clinical data for the use of odevixibat patients with moderate or severe renal impairment or end-stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
No dose adjustment is required for patients with mild or moderate hepatic impairment (see sections 5.1 and 5.2).
No data are available for PFIC patients with severe hepatic impairment (Child Pugh C). Additional monitoring for adverse reactions may be warranted in these patients when odevixibat is administered (see section 4.4).
The safety and efficacy of odevixibat in children aged less than 6 months has not been established. No data are available.
Bylvay is for oral use. To be taken with or without food in the morning (see section 5.2).
The larger 200 mcg and 600 mcg capsules are intended to be opened and sprinkled on food but may be swallowed whole.
The smaller 400 mcg and 1 200 mcg capsules are intended to be swallowed whole but may be opened and sprinkled on food or in a liquid.
If the capsule is to be swallowed whole, the patient should be instructed to take it with a glass of water in the morning.
Administration in soft foods:
Administration in liquids (requires use of an oral syringe):
For capsules to be opened and sprinkled in a liquid, the caregiver should be instructed to:
An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea and gastrointestinal effects.
The maximum dose administered to healthy subjects in clinical trials was odevixibat 10 000 mcg as a single dose, without any adverse consequences.
In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
3 years.
Store in the original package in order to protect from light. Do not store above 25°C.
High-density polyethylene (HDPE) bottle with a tamper evident, child resistant polypropylene closure.
Pack size: 30 hard capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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