Revumenib (LuciRevu)

Each tablet contains Revumenib citrate hydrate equivalent to Revumenib………………25 mg

Each tablet contains Revumenib citrate hydrate equivalent to Revumenib……………110 mg

Each tablet contains Revumenib citrate hydrate equivalent to Revumenib……………160mg

INDICATION

LuciRevu is a menin inhibitor indicated for:

Relapsed or Refractory Acute Leukemia (R/R Acute Leukemia)

• The treatment of adults and pediatric patients 1 year and older with relapsed or refractory acute leukemia harboring a KMT2A (MLL) gene translocation.

DOSAGE AND USE

Recommended Dosage:

The dosage of LuciRevu is based on patient weight and use of strong CYP3A4 inhibitors.

• Do not start LuciRevu until WBC is reduced to < 25 × 10⁹/L.
• Continue treatment until disease progression or unacceptable toxicity.
• Treat for a minimum of 6 months in the absence of progression.

Administration:

• Administer LuciRevu twice daily, fasted or with a low-fat meal (e.g., ~400 calories, ≤25% fat).
• Take at the same time each day.
• Tablets may be crushed and dispersed in water if swallowing is difficult.

Dose reductions and management for adverse reactions should follow the instructions provided in the full prescribing information.

WARNINGS

• Keep medicine out of reach of children.
• Do not administer LuciRevu during pregnancy or lactation.
• LuciRevu may cause differentiation syndrome, QTc prolongation, embryo-fetal toxicity, and other serious adverse reactions.

STORAGE

Store in a dry place and at 20°C to 25°C.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS (LAO) CO., LTD

No.26, Thongmang Village, Xaythany District, Vientiane Capital, Laos