Atrasentan

EACH LUCIATRAS TABLET CONTAINS: Atrasentan ………………… 0.75 mg

INDICATION

LuciAtras is indicated to reduce proteinuria in adult patients with primary immunoglobulin A
nephropathy (IgAN) who are at risk of rapid disease progression, generally defined as a urine
protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.

This indication is approved under accelerated approval based on reduction of proteinuria. It has
not been established whether LuciAtras slows the decline of kidney function. Continued
approval may be contingent upon verification of clinical benefit in confirmatory trials.

DOSAGE AND USE

Recommended Dosage in Adults:
0.75 mg orally once daily, with or without food.

Tablets should be swallowed whole and must not be cut, crushed, or chewed.

If a dose is missed, take the next dose at the scheduled time. Do not double the dose to make
up for a missed dose.

Pregnancy must be excluded prior to initiation of therapy.

DOSAGE FORM AND STRENGTH

Tablets: 0.75 mg, round, white, film-coated tablets debossed with “Lus” on one side.

STORAGE

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Store and dispense in the original container.
• Keep medicine out of the reach of children.

WARNING AND PRECAUTION

• Contraindicated in pregnancy due to the risk of embryo-fetal toxicity.
• Exclude pregnancy before starting treatment.
• Contraindicated in patients with known hypersensitivity to atrasentan or any component
• of the product.
• To be sold by retail on the prescription of a registered physician only, and used as directed by the physician.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS (LAO) CO., LTD
No. 26, Thongmang Village, Xaythany District, Vientiane Capital, Laos.