Revuforj is a targeted menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with KMT2A gene translocation. As an innovative targeted drug, its unique mechanism of action may be associated with specific risks such as Differentiation Syndrome (DS) and QT interval prolongation.

Precautions for Administration of Revuforj

Patient Screening Criteria

Revuforj is only applicable to patients with acute leukemia (including adults and children aged 1 year and above) who have been confirmed to have KMT2A gene translocation through testing.

Before initiating treatment, the status of KMT2A translocation must be confirmed via bone marrow cell testing, and the white blood cell count must be reduced to below 25 Gi/L.

For patients at risk of central nervous system recurrence, concurrent use of standard intrathecal chemotherapy prophylaxis is recommended.

Administration in Special Populations

Pregnant Women: Animal studies have shown that Revuforj can cause embryonic death, malformations, and growth restriction. Pregnancy testing must be performed before administration. Effective contraceptive measures should be taken during treatment and for 4 months after discontinuing the drug.

Lactating Women: Breastfeeding is prohibited during treatment and within 1 week after the last dose.

Pediatric Patients: The safety of Revuforj in infants under 1 year of age has not been established. For children aged 1 year and above, the dose needs to be adjusted based on body weight and body surface area.

Elderly Patients: Patients aged 65 years and above have a higher incidence of QT interval prolongation and edema, requiring enhanced monitoring.

Dosage Regimen

Revuforj should be taken orally twice daily (approximately 12 hours apart), either with a low-fat meal or on an empty stomach.

Tablets should be swallowed whole. For patients unable to swallow tablets, the tablets can be crushed and mixed with water, but the mixture must be administered within 2 hours.

If a dose is missed, it should be taken as soon as possible on the same day, with an interval of at least 12 hours before the next scheduled dose.

Dosage Adjustment for Adverse Reactions

Differentiation Syndrome (DS): Initiate corticosteroid treatment immediately and discontinue Revuforj. Resume the original dose after resolution of symptoms.

QTc > 500 ms: Discontinue administration. After correcting electrolyte abnormalities, resume treatment at a reduced dose.

Grade ≥ 3 Non-hematological Toxicity: Discontinue treatment until toxicity resolves to Grade ≤ 1. Resume at the original dose for the first occurrence; reduce the dose for subsequent occurrences.

Grade 4 Hematological Toxicity: Discontinue treatment until toxicity resolves to Grade ≤ 2. Dose reduction is required for recurrent occurrences.

Key Monitoring Points During Revuforj Treatment

Electrocardiogram (ECG) Monitoring

Revuforj may cause QT interval prolongation. Before administration, the baseline QTcF must be confirmed to be < 450 ms.

A baseline ECG must be performed before initiating treatment.

First 4 weeks of treatment: ECG monitoring at least once a week.

After 4 weeks: ECG monitoring at least once a month.

High-risk patients (e.g., those receiving concurrent QT-prolonging drugs): Increased frequency of monitoring is required.

Laboratory Monitoring

Before Treatment: Complete blood count, electrolytes (potassium/magnesium), liver function, and parathyroid hormone.

During Treatment: Monitor the above indicators monthly.

Management of Electrolyte Abnormalities

Serum potassium: 3.6–3.9 mEq/L or serum magnesium: 1.7–1.9 mg/dL: Supplement electrolytes and continue medication.

Serum potassium: ≤ 3.5 mEq/L or serum magnesium: ≤ 1.6 mg/dL: Immediately supplement electrolytes and recheck within 24 hours. If abnormalities are not corrected, discontinue Revuforj.

Monitoring for Differentiation Syndrome

Approximately 29% of patients may develop this potentially life-threatening complication. Close monitoring for the following symptoms is required:

Fever, dyspnea, hypoxemia;

Pulmonary infiltrates, pleural/pericardial effusion;

Rapid weight gain, peripheral edema;

Hypotension, renal insufficiency.