Dordaviprone

EACH LUCIDORDA CAPSULE CONTAINS: Dordaviprone …………… 125 mg

INDICATION

LuciDorda (Dordaviprone Capsules 125 mg) is an anti-cancer medication used for the treatment of diffuse midline glioma (a type of brain tumor).

LuciDorda is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma (DMG) harboring an H3K27M mutation who require systemic therapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

DOSAGE AND USE

Select patients for treatment with LuciDorda based on the presence of an H3K27M mutation in tumor specimens.

Recommended Dosage:

Recommended dosage is 625 mg orally once weekly based on body weight (≥10 kg).

Continue treatment until disease progression or unacceptable toxicity.

Capsules should be swallowed whole.

DOSAGE FORM AND STRENGTH

Capsules: 125 mg, hard capsules, size 3, light blue cap and white body, containing white to off-white powder.

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).

Keep medicine out of the reach of children.

WARNING AND PRECAUTION

• Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis, have occurred.
• QT Interval Prolongation: Monitor ECGs and electrolytes prior to and during treatment.
• Embryo-fetal Toxicity: May cause fetal harm; advise effective contraception.

CONTRAINDICATIONS

None.

MANUFACTURED AND MARKETED BY

LUCIUS PHARMACEUTICALS (LAO) CO., LTD

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