Detailed introduction to the instruction manual of revumenib

　　On October 24,2025,Syndax Pharmaceuticals announced that the U.S.Food and Drug Administration(FDA)has approved Revuforj(revumenib)for the treatment of adult and pediatric patients aged 1 year and older with relapsed or refractory(R/R)acute myeloid leukemia(AML)carrying nucleolar phosphoprotein 1(NPM1)mutations and for whom there are no suitable alternative treatment options.Revuforj was previously approved in 2024 for the treatment of adult and pediatric patients aged 1 year and older with R/R acute leukemia associated with a lysine methyltransferase 2A gene(KMT2A)translocation.

　　According to the press release,this approval makes Revuforj the first FDA-approved therapy for R/R acute leukemia that covers both R/R AML carrying NPM1 mutations and R/R AML with KMT2A translocations.

　　【Manufacturer】:Syndax Pharmaceuticals,Inc

　　[Specifications]:25mg*30 tablets,110mg*30 tablets,160mg*30 tablets.

　　[Trademark]:Revuforj

　　【Common name】:revumenib

　　[Chinese Name]:Ruiwei Meini

　　[Description]:(1)25mg:pink modified oval film-coated tablet,with"S"imprinted on one side and"25"on the other.(2)110mg:beige modified oval film-coated tablet,with"S"imprinted on one side and"110"on the other.

　　(3)160mg:Purple modified oval film-coated tablet,with"S"imprinted on one side and"160"imprinted on the other side.

　　[Storage]:Store in original packaging at 20°C to 25°C;brief storage at 15°C to 30°C is permissible.

　　【Indications and Uses of Revuforj】

　　Revuforj is indicated for the treatment of relapsed or refractory acute leukemia:

　　(1)Adult and pediatric patients aged 1 year and above with relapsed or refractory(R/R)acute leukemia accompanied by a translocation involving the lysine methyltransferase 2A gene(KMT2A).

　　(2)Adult and pediatric patients aged 1 and above with relapsed or refractory(R/R)acute myeloid leukemia(AML)carrying a nucleophosmin 1(NPM1)mutation and without suitable alternative treatment options.

　　【Revuforj Usage and Dosage】

　　1.Patient selection:

　　1)Relapsed or refractory acute leukemia with KMT2A translocation:Patients receiving this product treatment are selected based on the presence or absence of KMT2A translocation.

　　2)Relapsed or refractory acute myeloid leukemia with NPM1 mutation:Patients receiving this product are selected based on the presence or absence of NPM1 mutations.Currently,there is no FDA-authorized companion diagnostic test for detecting NPM1 mutations.

　　2.Recommended Dose:The recommended dose of this product varies depending on the patient's body weight and concurrent use of strong CYP3A4 inhibitors.For patients aged 1 year and above,please refer to Table 1 for the recommended dose.Do not start taking this product until the white blood cell count drops below 25 Gi/L.Continue taking this product until disease progression or unacceptable toxicity occurs.For patients who do not experience disease progression or unacceptable toxicity,treatment should be maintained for at least 6 months to allow time for clinical response.

　　3.Administration method:

　　•Correct hypokalemia,hypomagnesemia,and other electrolyte imbalances before treatment.

　　•Take orally twice daily,either on an empty stomach or after a low-fat meal(for example,a meal with approximately 400 calories and a fat content of no more than 25%).

　　•Take orally at approximately the same time every day.

　　•Inform the patient to swallow the tablets intact and not to cut or chew them.If the patient is unable to swallow the tablets,they can be crushed and dispersed in water,and then consumed within 2 hours of preparation.

　　•If you miss a dose or do not take it at the usual time,you should take it as soon as possible on the same day and at least 12 hours before the next scheduled dose.Resume your regular medication schedule the next day.Please do not take two doses within 12 hours.

　　For patients who cannot swallow a whole tablet,the tablet should be crushed and dispersed in water,and administered through an oral syringe.

　　Patients who can swallow the entire tablet should not cut,chew,or break the tablet in water.

　　4.Dose adjustment for adverse reactions:

　　Before starting to take this product,blood cell count,electrolytes,and liver enzymes should be tested,and then tested monthly.Before starting to take this product,an electrocardiogram(ECG)should be performed,followed by at least one examination per week for the first 4 weeks,and then at least one examination per month thereafter.Monitor whether the QTc interval is prolonged and promptly address any abnormalities[see Warnings and Precautions,Adverse Reactions].According to the provisions in Table 3,the medication should be discontinued or the dose reduced for adverse reactions.