Revuforj (revumenib) 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 accompanied by specific risks such as differentiation syndrome (DS) and QT interval prolongation.

Precautions for Revuforj (Revumenib) Administration

Patient Selection Criteria

Revuforj is only indicated for patients with acute leukemia confirmed to have KMT2A gene translocation through testing, including adults and children aged 1 year and older.

Before initiating medication, the KMT2A translocation status must be confirmed via bone marrow cell testing, and treatment can only start when the white blood cell count has decreased to below 25 Gi/L.

For patients at risk of central nervous system relapse, it is recommended to concurrently use standard intrathecal chemotherapy prophylaxis regimens.

Medication Use 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 medication use, and effective contraceptive measures should be taken during treatment and for 4 months after discontinuing the drug.

Lactating Women: Breastfeeding is prohibited during medication use 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 older, the dose needs to be adjusted based on body weight and body surface area.

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

Administration 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 consumed 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 from the next scheduled dose.

Dose Adjustment for Adverse Reactions

Differentiation Syndrome (DS): Immediately initiate corticosteroid treatment and discontinue Revuforj. Resume the original dose after symptoms resolve.

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

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

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

Key Monitoring Points During Revuforj (Revumenib) Treatment

Electrocardiogram (ECG) Monitoring

Revuforj can cause QT interval prolongation; baseline QTcF must be confirmed to be < 450 ms before medication use.

A baseline ECG must be performed before starting treatment.

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

After 4 weeks: ECG at least once a month.

High-risk patients (e.g., those taking concomitant QT-prolonging drugs): The frequency of monitoring needs to be increased.

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 use.

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 (DS)

Approximately 29% of patients may develop this potentially life-threatening complication. Closely monitor for the following symptoms:

Fever, dyspnea, hypoxemia.

Pulmonary infiltrates, pleural/pericardial effusions.

Rapid weight gain, peripheral edema.

Hypotension, renal insufficiency.