Vadadustat Tablets 150mg

LuciVadadu (Vadadustat Tablets 150mg)

EACH FILM-COATED LUCIVADADU TABLET CONTAINS: Vadadustat…………..150mg

INDICATIONS

LuciVadadu is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

DOSAGE

Important Dosing Information

Individualize dosing and use the lowest dose of LuciVadadu sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin level higher than 11 g/dL.

• LuciVadadu can be taken with or without food.
• LuciVadadu should be swallowed whole. Tablets should not be cut, crushed, or chewed.
• LuciVadadu can be administered without regard to the timing or type of dialysis.
• If a dose of LuciVadadu is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped, and the next dose taken at the usual time. Double doses should not be taken to make-up for a missed dose.

Recommended Starting Dose of LuciVadadu

Adults Not Being Treated with an ESA

The recommended starting dose is 300 mg orally once daily.

Adults Being Switched from an ESA

When converting from an ESA to LuciVadadu, the recommended starting dose is 300 mg orally once daily.

LuciVadadu should be paused for those patients receiving temporary ESA rescue treatment and may be resumed when Hb levels are greater than or equal to 10 g/dL. Depending on the ESA used, the pause in LuciVadadu treatment should be extended to:

• 2 days after the last dose of epoetin
• 7 days after the last dose of darbepoetin alfa
• 14 days after the last dose of methoxy polyethylene glycol-epoetin beta.

Following ESA rescue, LuciVadadu should be resumed at the prior dose or with a dose that is 150 mg greater than the prior dose, with subsequent titrations according to the dose titration guidelines given in the following section.

STORAGE

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS(LAO) CO., LTD

Address: Thongmang village, Xaythany district, Vientiane Capital, Laos