Niraparib

This drug manufactured by Lucius Pharmaceuticals, as a novel menin inhibitor, offers a precision-targeted therapy option for patients with acute leukemia harboring specific gene mutations.

Active Ingredient

The active ingredient is revumenib, a menin inhibitor.

Indicated Population

Indicated for adult and pediatric patients aged 1 year and older with confirmed KMT2A translocation or NPM1 mutation detected by testing.

Dosage and Administration

Administer orally twice daily, either on an empty stomach or with a low-fat meal. The specific dosage shall be adjusted according to the patient’s body weight and concurrent use of potent CYP3A4 inhibitors.

Medication Use in Special Populations

Contraindicated in pregnant women.

Patients of childbearing potential must use effective contraceptive measures.

Breastfeeding women are not recommended to breastfeed during treatment and within 1 week after discontinuation of the drug.

Drug Overdose

No clear information is available regarding drug overdose. It is recommended to administer the medication in accordance with the doctor’s instructions.

Storage Conditions

Store the medication at room temperature between 20°C and 25°C. Keep it in the original packaging to protect from moisture and ensure child safety.

Pharmacokinetics

Pharmacokinetic data show that revumenib is metabolized via CYP3A4, with a relatively short half-life. Its plasma concentration is affected by food and drug-drug interactions.

FDA，2025.10