Odevixibat is an ileal bile acid transporter (IBAT) inhibitor used to treat pruritus associated with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS).

I. Use in Pregnancy and Lactation

1. Use in Pregnancy

Animal studies show that odevixibat may cause fetal cardiovascular malformations, and exposure during pregnancy may pose a risk.

Odevixibat may inhibit the absorption of fat-soluble vitamins, which are essential for normal fetal growth and development.

Fat-soluble vitamin levels should be monitored during pregnancy, supplemented when necessary, and increased supplementation may be needed.

Medication use requires weighing the mother's treatment needs, potential fetal risks, and adverse outcomes from untreated maternal disease.

A pregnancy safety study is available, and pregnant women exposed to odevixibat or their healthcare providers should report the exposure.

2. Use in Lactation

Odevixibat has low oral absorption, and infant exposure through breast milk is not expected at recommended doses.

There are no data on the presence of odevixibat in human milk, its effects on the breastfed infant, or its effects on milk production.

Odevixibat may reduce the absorption of fat-soluble vitamins, and fat-soluble vitamin levels should be monitored during lactation, with increased intake if deficiency is observed.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects of the drug or maternal condition on the infant.

II. Pediatric Use

1. Patients with PFIC

The safety and effectiveness of odevixibat for the treatment of pruritus in patients with PFIC aged 3 months and older have been established.

The safety and effectiveness of this indication in PFIC patients younger than 3 months have not been established.

2. Patients with ALGS

The safety and effectiveness of odevixibat for the treatment of cholestatic pruritus in patients with ALGS aged 12 months and older have been established.

The safety and effectiveness of this indication in ALGS patients younger than 12 months have not been established.

III. Other Special Populations

1. Geriatric Patients

PFIC and ALGS are mainly seen in children and young adults.

Clinical studies of odevixibat did not include patients aged 65 years and older.

2. Patients with Hepatic Impairment

Patients with PFIC and ALGS may have hepatic impairment.

The efficacy and safety of odevixibat in patients with clinically significant portal hypertension or decompensated cirrhosis have not been established.

Odevixibat is contraindicated in patients with decompensated cirrhosis.

Patients with compensated cirrhosis or portal hypertension should be monitored more frequently, and odevixibat should be permanently discontinued if hepatic decompensation occurs.

3. Risk of Fat-Soluble Vitamin Deficiency

Odevixibat may affect the absorption of fat-soluble vitamins A, D, E, and K.

Baseline levels should be obtained before treatment, monitored during treatment, and supplemented if deficiency is found.

If deficiency persists or worsens despite supplementation, permanent discontinuation should be considered.

If complications of fat-soluble vitamin deficiency occur, consider interrupting treatment and reassessing supplementation.