Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
KAYFANDA is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) 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 ALGS.
The recommended dose of odevixibat is 120 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 120 mcg/kg/day dose, with a maximum daily dose of 7 200 mcg per day.
Table 1. Number of odevixibat capsules needed to achieve the nominal dose of 120 mcg/kg/day:
| Body weight (kg) | Total mcg dose | Number of 600 mcg capsules | Number of 1 200 mcg capsules | |
|---|---|---|---|---|
| 4 to <7.5 | 600 | 1 | or | Not applicable (N/A) |
| 7.5 to <12.5 | 1 200 | 2 | or | 1 |
| 12.5 to <17.5 | 1 800 | 3 | or | N/A |
| 17.5 to <25.5 | 2 400 | 4 | or | 2 |
| 25.5 to <35.5 | 3 600 | 6 | or | 3 |
| 35.5 to <45.5 | 4 800 | 8 | or | 4 |
| 45.5 to <55.5 | 6 000 | 10 | or | 5 |
| ≥55.5 | 7 200 | 12 | or | 6 |
Capsule strength/number in bold is recommended based on predicted ease of administration. If necessary, any of the four capsule strengths can be combined as needed to achieve the nominal dose.
Dose reduction to 40 mcg/kg/day may be considered if tolerability issues (diarrhoea that lasts ≥3 days, is considered severe, or requires IV hydration (see section 4.4)) occur in the absence of other causes. Once tolerability issues stabilise, the dose should be increased to 120 mcg/kg/day.
Table 2 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 2. Number of odevixibat capsules needed to achieve the nominal dose of 40 mcg/kg/day:
| Body weight (kg) | Total mcg dose | Number of 200 mcg capsules | Number of 400 mcg capsules | |
|---|---|---|---|---|
| 4 to <7.5 | 200 | 1 | or | N/A |
| 7.5 to <12.5 | 400 | 2 | or | 1 |
| 12.5 to <17.5 | 600 | 3 | or | N/A |
| 17.5 to <25.5 | 800 | 4 | or | 2 |
| 25.5 to <35.5 | 1 200 | 6 | or | 3 |
| 35.5 to <45.5 | 1 600 | 8 | or | 4 |
| 45.5 to <55.5 | 2 000 | 10 | or | 5 |
| ≥55.5 | 2 400 | 12 | or | 6 |
Capsule strength/number in bold is recommended based on predicted ease of administration. If necessary, any of the four capsule strengths can be combined as needed to achieve the nominal dose.
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 renal impairment. There are no available clinical data for the use of odevixibat in patients with moderate or severe renal impairment or end-stage renal disease (ESRD) requiring haemodialysis. However, due to the minimal plasma concentrations and negligible renal excretion, no dose adjustment is required for these patients (see section 5.2).
No dose adjustment is required for patients with mild or moderate hepatic impairment (see sections 5.1 and 5.2).
Odevixibat has not been sufficiently studied in patients with severe hepatic impairment (Child-Pugh C). Due to minimal absorption, no dose adjustment is required. Close monitoring, however, is advised for patients with end-stage liver disease or progression to decompensation (see section 4.4).
The safety and the efficacy of odevixibat in children aged less than 6 months have not been established. No data are available.
KAYFANDA 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 or in a liquid 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.
For capsules to be opened and sprinkled on soft food, the patient/caregiver should be instructed to:
For capsules to be opened and sprinkled in a liquid, the patient/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.
The maximum dose administered to healthy adult 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.
4 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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