Odevixibat

Each capsule contains Odevixibat sesquihydrate 415 mcg equivalent to Odevixibat………………….400mcg.

INDICATION:

LuciOdevi is an ileal bile acid transporter (IBAT) inhibitor indicated for:

Progressive Familial Intrahepatic Cholestasis (PFIC)

• The treatment of pruritus in adult with progressive familial intrahepatic cholestasis (PFIC).

Alagille Syndrome (ALGS)

• The treatment of cholestatic pruritus in adult with Alagille syndrome (ALGS).

LIMITATIONS OF USE:

LuciOdevi may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in nonfunctional or complete absence of the bile salt export pump protein.

DOSAGE AND USE:

Recommended Dosage:

PFIC:40 mcg/kg taken orally once daily.

• If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily, not to exceed a daily dosage of 6 mg/day.
• ALGS:120 mcg/kg taken orally once daily.

STORAGE:

In a dry place and store at 20°C to 25°C.

WARNINGS:

Keep medicine out of reach of Children. Do not administer LuciOdevi during Pregnancy and Lactation.