HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciDorda safely and effectively. See full prescribing information for LuciDorda.

INDICATIONS AND USAGE

LuciDorda is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.

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

DOSAGE AND ADMINISTRATION

• Select patients for treatment with LuciDorda based on the presence of an H3 K27M mutation from tumor specimens.

• Monitor ECG and electrolytes before starting LuciDorda and periodically during treatment as clinically indicated.

• The recommended dose in adult patients is 625 mg orally once weekly.

• The recommended dose in pediatric patients weighing ≥10 kg is based on body weight.

• Take LuciDorda orally once weekly on an empty stomach (at least 1 hour before or 3 hours after food intake).

• Continue LuciDorda until disease progression or unacceptable toxicity.

DOSAGE FORMS AND STRENGTHS

Capsules：125 mg×10 capsules

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Hypersensitivity: If clinically significant hypersensitivity or anaphylaxis occur, immediately discontinue LuciDorda and initiate appropriate medical treatment and supportive care.

•QTc Interval Prolongation: LuciDorda causes concentration dependent QTc interval prolongation. Interrupt or reduce the dose of LuciDorda in patients who develop QT prolongation, and permanently discontinue LuciDorda in patients with signs of life threatening arrhythmias.

• Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are fatigue, headache, vomiting, nausea, and musculoskeletal pain. The most common (≥2%) Grade 3 or 4 laboratory abnormalities are decreased lymphocytes, decreased calcium, and increased alanine aminotransferase.

DRUG INTERACTIONS

• CYP3A4 Inhibitors: Avoid concomitant use of strong and moderate CYP3A4 inhibitors with LuciDorda. If concomitant use cannot be avoided for adults and pediatric patients who weigh at least 52.5 kg, reduce the dose of LuciDorda as recommended.

• CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers with LuciDorda.

• Drugs Known to Prolong QTc Interval: Avoid concomitant use of LuciDorda with products known to prolong the QTc interval. If concomitant use cannot be avoided, separate administration of LuciDorda and the QT-prolonging product.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

Storage

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