For adults and children 1 year and older with acute leukemia with a KMT2A translocation whose disease has come back or has not improved after previous treatment(s) or AML with an NPM1 mutation whose disease has come back or has not improved after previous treatment(s) and who have no other satisfactory treatment options.

A first-of-its-kind
targeted treatment

for certain types of acute leukemia

Revuforj® (revumenib) Targeted Action

NOW APPROVED

for NPM1m AML
Select one of the below:
KMT2A-translocated
acute leukemia
NPM1-mutated AML
NEW INDICATION

Important Safety Information

What is the most important information I should know about Revuforj?

Revuforj may cause serious side effects, including:
Differentiation syndrome. Differentiation syndrome is a serious but common condition that affects your blood cells, which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 3 days and up to 41 days after starting Revuforj. Tell any healthcare provider caring for you that you are taking a medicine that can cause differentiation syndrome. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking Revuforj:

  • fever
  • cough
  • shortness of breath
  • severe headache
  • confusion
  • dizziness or lightheadedness
  • fast weight gain
  • swelling of arms, legs, neck, groin, or underarm area
  • decreased urination
  • rash

If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.

Changes in electrical activity of your heart called QT prolongation. QT prolongation is a serious but common side effect that can cause irregular heartbeats that can be life-threatening, such as a heart attack, and can lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with Revuforj. Tell your healthcare provider right away if you feel faint, lightheaded, dizzy, or if you feel your heart beating irregularly or fast during treatment with Revuforj.

Before taking Revuforj, tell your healthcare provider about all your medical conditions, including if you:
  • have any heart problems, including a condition called long QT syndrome
  • have been told you have low blood levels of potassium or magnesium

  • are pregnant or plan to become pregnant. Revuforj can harm your unborn baby
    Females who are able to become pregnant

    • Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with Revuforj
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Revuforj
    • Use effective birth control (contraception) during treatment with Revuforj and for 4 months after the last dose of Revuforj

    Males who have female partners who are able to become pregnant

    • Use effective birth control during treatment with Revuforj and for 4 months after the last dose of Revuforj
    • Talk to your healthcare provider about birth control methods you can use during this time
  • Revuforj may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you
  • are breastfeeding or plan to breastfeed. It is not known if Revuforj passes into your breast milk. Do not breastfeed during your treatment with Revuforj or for 1 week after your last dose of Revuforj

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Revuforj and other medicines may affect each other, causing side effects.

The most common side effects of Revuforj include:

  • infections, including bacterial and viral
  • changes in liver function tests
  • bleeding (hemorrhage)
  • nausea and vomiting
  • muscle pain
  • low white blood cell counts with fever
  • diarrhea
  • tiredness
  • swelling in the arms and legs
  • decreased appetite
  • constipation

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Revuforj if you develop certain side effects. These are not all the possible side effects of Revuforj. Call your healthcare provider for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is Revuforj?

Revuforj® (revumenib) is a prescription medicine used to treat adults and children 1 year and older with:

  • acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation whose disease has come back or has not improved after previous treatment(s)
  • acute myeloid leukemia with a nucleophosmin 1 (NPM1) mutation whose disease has come back or has not improved after previous treatment(s) and who have no other satisfactory treatment options

Please see Full Prescribing Information, including BOXED WARNINGS, and Medication Guide and Instructions for Use.

Important Safety Information

What is the most important information I should know about Revuforj?

Revuforj may cause serious side effects, including:
Differentiation syndrome: Differentiation syndrome is a serious but common condition that affects your blood cells, which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 3