HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciVora is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.

DOSAGE AND ADMINISTRATION

• Recommended dosage in adults:

• 40 mg orally once daily.

• Recommended dosage in pediatric patients 12 years of age and older based on body weight:

• ≥40 kg: 40 mg orally once daily.

• <40 kg: 20 mg orally once daily.

• Take with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 40 mg×30 tablets

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Monitor liver function tests every 2 weeks during the first 2 months of treatment, then monthly for the first 2 years of treatment, and as clinically indicated. Withhold, reduce the dose or discontinue LuciVora based on severity.

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

ADVERSE REACTIONS

The most common (≥15%) adverse reactions include fatigue, headache, COVID-19, musculoskeletal pain, diarrhea, nausea, and seizure.

Grade 3 or 4 (≥2%) laboratory abnormalities were ALT increased, AST increased, GGT increased, and neutrophils decreased.

DRUG INTERACTIONS

• CYP1A2 Inhibitors: Avoid concomitant use of strong and moderate CYP1A2 inhibitors.

• CYP1A2 Inducers: Avoid concomitant use of moderate CYP1A2 inducers and smoking tobacco.

• Certain CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where a minimal concentration change can reduce efficacy.

• Hormonal Contraception: If concomitant use cannot be avoided, use with nonhormonal contraception methods.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

• Infertility: May impair fertility in males and females.

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.