Odevixibat oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Side Effects
- Monograph
Presentation
Oral formulations of odevixibat.
Drugs List
Therapeutic Indications
Uses
Cholestasis - congenital
Treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
Dosage
Adults
40microgram/kg once daily in the morning.
If after 3 months of continuous therapy, an adequate clinical response has not been achieved, the dose may be increased to 120micrograms/kg/day. The maximum daily dose is 7.2mg per day.
Children
Children aged 6 months and older
40microgram/kg once daily in the morning.
If after 3 months of continuous therapy, an adequate clinical response has not been achieved, the dose may be increased to 120micrograms/kg/day. The maximum daily dose is 7.2mg per day.
Contraindications
Children under 6 months
Breastfeeding
Pregnancy
Precautions and Warnings
Females of childbearing potential
Haemodialysis
Moderate renal impairment
Severe hepatic impairment
Maintain adequate hydration during therapy
Treatment to be initiated and supervised by a specialist
Contains propylene glycol
Assess fat-soluble vitamin levels prior to and during therapy
Perform liver function tests before commencing therapy and during therapy
Female: Ensure adequate contraception during treatment
Patients with PFIC2 who have a complete absence or lack of function of Bile Salt Export Pump (BSEP) protein (i.e. patients with BSEP3 subtype of PFIC2) will not respond to odevixibat.
There are limited or no clinical data with odevixibat in PFIC subtypes other than 1 and 2.
Additional monitoring for adverse side effects is advised when odevixibat is administered to patients with severe hepatic impairment (Child Pugh C).
For patients with liver function test elevations, more frequent monitoring should be considered.
Counselling
The 200mcg capsules are intended to be opened and sprinkled on food but may be swallowed whereas the 400mcg and 1200mcg capsules are intended to be swallowed whole but may also be opened and sprinkled on food. The contents should be sprinkled on to soft food such as yoghurt, apple sauce, oatmeal porridge, banana puree, carrot puree, chocolate-flavoured pudding or rice pudding that is at or below room temperature.
Side Effects
Abdominal pain
Diarrhoea
Haemorrhagic diarrhoea
Hepatomegaly
Soft faeces
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2022
Reference Sources
Summary of Product Characteristics: Bylvay 200 micrograms hard capsules. Albireo Pharma. Revised September 2021.
Summary of Product Characteristics: Bylvay 400 micrograms hard capsules. Albireo Pharma. Revised September 2021.
Summary of Product Characteristics: Bylvay 1200 micrograms hard capsules. Albireo Pharma. Revised September 2021.
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