Revumenib Side Effects

Applies to revumenib: oral tablet.

Important warnings This medicine can cause some serious health issues

Revumenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated.

This condition may occur within 3 days to 41 days after you start taking revumenib.

Tell your medical caregivers if you have signs of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Revumenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 3 days to 41 days after you start taking revumenib. Seek medical help right away if you have symptoms of differentiation syndrome: fever, cough, trouble breathing, dizziness, rash, decreased urination, rapid weight gain, or swelling in your arms or legs.

Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out).

Your cancer treatments may be delayed, changed, or permanently discontinued if you have certain side effects.

Common side effects may include:

• muscle pain, tiredness, loss of appetite;

• bleeding;

• bacterial or viral infections, low white blood cells, fever;

• abnormal blood tests;

• swelling in your arms and legs; or

• nausea, diarrhea, constipation, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to revumenib: oral tablet.

General adverse events

The most common side effects were constipation, edema, decreased appetite, decreased phosphate, decreased potassium, ECG QT prolonged, fatigue, febrile neutropenia, bacterial infection, diarrhea, differentiation syndrome, hemorrhage, infection, increased AST, increased ALT, increased alkaline phosphatase, increased phosphate, increased parathyroid hormone intact, increased triglycerides, musculoskeletal pain, nausea, and viral infection.

The most frequently reported serious side effects included infection (24%), febrile neutropenia (19%), bacterial infection (17%), differentiation syndrome (12%), hemorrhage (9%), and thrombosis (5%).

The most common side effects resulting in dose interruption were differentiation syndrome, ECG QT prolonged, febrile neutropenia, hypokalemia, infection, and nausea.^[Ref]

Cardiovascular

• Very common (10% or more): ECG QT prolonged (up to 29%), thrombosis (up to 10%)
• Frequency not reported: Cardiac failure, pericardial effusion, ventricular tachycardia, cardiac arrest

Thrombosis included disseminated intravascular coagulation, pulmonary embolism, cerebrovascular accident, deep vein thrombosis, embolism, hemorrhoids thrombosed, medical device site thrombosis, renal infarct, superficial vein thrombosis, thrombosis, and transient ischemic attack.

Dermatologic

• Frequency not reported: Rash

Endocrine

• Very common (10% or more): Increased parathyroid hormone intact (up to 33%)
• Frequency not reported: Hyperparathyroidism

Gastrointestinal

• Very common (10% or more): Nausea (up to 51%), diarrhea (up to 30%), constipation (up to 23%)
• Frequency not reported: Abdominal pain

Nausea included nausea and vomiting.

Diarrhea included diarrhea, colitis, and neutropenic colitis.

Hematologic

• Very common (10% or more): Hemorrhage (up to 53%), febrile neutropenia (up to 35%)
• Common (1% to 10%): Leukocytosis

Hemorrhage included epistaxis, contusion, petechiae, gingival bleeding, hematuria, mouth hemorrhage, hematoma, hemoptysis, hemorrhoidal hemorrhage, subdural hematoma, vaginal hemorrhage, catheter site hemorrhage, conjunctival hemorrhage, ecchymosis, hemorrhage intracranial, anal hemorrhage, brain stem hemorrhage, eye hematoma, gastrointestinal hemorrhage, genital contusion, hematochezia, injection site hematoma, lower gastrointestinal hemorrhage, melena, mucosal hemorrhage, oral contusion, pulmonary, upper gastrointestinal hemorrhage, and vitreous hemorrhage.

Hepatic

• Very common (10% or more): Increased AST (up to 37%), increased ALT (up to 33%)

Hypersensitivity

• Frequency not reported: Drug hypersensitivity

Metabolic

• Very common (10% or more): Decreased appetite (up to 24%)
• Frequency not reported: Hyponatremia, hyperkalemia

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (up to 42%)

Musculoskeletal pain included back pain, arthralgia, pain in extremity, neck pain, myalgia, musculoskeletal chest pain, myositis, flank pain, musculoskeletal discomfort, and musculoskeletal pain.

Nervous system

• Frequency not reported: Taste disorder, syncope, headache, paresthesia

Ocular

• Frequency not reported: Cataract

Other

• Very common (10% or more): Increased phosphate (up to 50%), infection (up to 41%), bacterial infection (up to 31%), differentiation syndrome (up to 29%), decreased phosphate (up to 25%), increased triglycerides (up to 25%), decreased potassium (up to 24%), viral infection (up to 23%), edema (up to 23%), fatigue (up to 22%), increased alkaline phosphatase (up to 21%), increased cholesterol (up to 19%), increased corrected calcium (up to 15%)
• Frequency not reported: Sudden death

Infection included sepsis, pneumonia, urinary tract infection, septic shock, sinusitis, upper respiratory tract infection, device related infection, skin infection, acute sinusitis, enterocolitis infectious, perirectal abscess, rectal abscess, rhinitis, abscess limb, appendicitis, bronchitis, conjunctivitis, endocarditis, epididymitis, eye infection, gastroenteritis, neutropenic sepsis, osteomyelitis, rash pustular, retinitis, shock, sialadenitis, tooth abscess, tooth infection, and vascular device infection.

Bacterial infection included bacteremia, cellulitis, Clostridioides difficile infection, staphylococcal bacteremia, paronychia, Clostridium test positive, Enterobacter infection, Enterobacter sepsis, Escherichia bacteremia, alpha hemolytic streptococcal infection, bacteriuria, cellulitis staphylococcal, Enterobacter bacteremia, enterococcal bacteremia, enterococcal infection, Escherichia urinary tract infection, folliculitis, Klebsiella infection, Klebsiella sepsis, Lactobacillus bacteremia, and pseudomonal bacteremia.

Viral infection included COVID-19, rhinovirus infection, respiratory syncytial virus infection, CMV infection reactivation, herpes simplex, herpes simplex reactivation, herpes zoster, COVID-19 pneumonia, coronavirus infection, CMV infection, CMV test positive, enterovirus infection, enterovirus test positive, Epstein-Barr virus infection, herpes simplex pharyngitis, herpes virus infection, norovirus infection, oral herpes, and pneumonia cytomegaloviral.

Edema included edema peripheral, generalized edema, edema, localized edema, and peripheral swelling.

Fatigue included fatigue and malaise.

Renal

• Very common (10% or more): Increased creatinine (up to 19%)
• Frequency not reported: Renal impairment

Further information

Revumenib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer