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Another NameLuciRevu、revumenib,瑞维美尼
IndicationsIt is indicated for adult and pediatric patients aged 1 year and above with relapsed or refractory acute leukemia harboring KMT2A gene translocation, or relapsed or refractory acute myeloid leukemia w
Reg No.11 L 1400/25
Inspection NO.2765-25
In November 2024, revumenib was approved for marketing by the U.S. Food and Drug Administration (FDA). Its targeted sites of action are menin and lysine methyltransferase 2A (KMT2A). As a prescription drug, it must be used strictly in accordance with the doctor’s instructions.
menin and Lysine Methyltransferase 2A (KMT2A)
The mechanism of action of revumenib is to target myeloid leukemia factor(menin) and block the protein interactions that drive leukemia cell proliferation in patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) harboring KMT2A gene rearrangements.
Route and Frequency of Administration for Revumenib: Oral administration,twice daily.
The dosage of revumenib needs to be adjusted according to the patient's actual condition. For specific circumstances, patients should consult their doctors and strictly follow the medical advice.
Recommended Reading: Dosage and Administration of Revumenib
Serious Adverse Reactions: Differentiation syndrome.
Common Adverse Reactions: Prolonged QT interval, etc.
Reference Article: Adverse Reactions of Revumenib
Pregnancy: The use of revumenib in pregnant women may cause fetal harm. For women of childbearing potential, pregnancy status should be confirmed within 7 days prior to the initiation of revumenib treatment.
Lactation: It is recommended that lactating women should not breastfeed during revumenib treatment and within 1 week after the last dose.
1. It is recommended that patients read the patient package insert (medication guide) approved by the U.S. Food and Drug Administration (FDA) and the instructions for use.
2. Patients should be informed that differentiation syndrome may occur as early as 1 day after the start of treatment or during the treatment period. If patients experience any suspected symptoms of differentiation syndrome, such as fever, cough, dyspnea, rash, hypotension, rapid weight gain, swelling of the arms or legs, decreased urine output, etc., they should immediately inform medical staff for further evaluation.
3. If patients experience dizziness, loss of consciousness, or any signs or symptoms suggesting arrhythmia, they should consult medical staff immediately, as these symptoms may indicate prolonged QTc interval. For patients with a history of hypokalemia or hypomagnesemia, the importance of electrolyte monitoring should be informed to them.
FDA，2025.10
