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Med Guide/IFU  |  Full Prescribing Information

Med Guide/IFU

Full Prescribing Information

Important Safety Information

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Revuforj 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).

About AML & ALL

What is Acute Leukemia?

What is acute leukemia?

Leukemia is a type of blood cancer that takes place in the bone marrow See less circle where normal blood cells are made. It starts with a single stem cell See less circle that becomes an abnormal cell—or a leukemia cell.

Normally, stem cells go through different stages before they fully develop into healthy blood cells, which include red blood cells, white blood cells, and platelets.

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Red blood cells carry oxygen all throughout your body

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White blood cells protect your body and fight infections

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Platelets help your blood clot to stop bleeding

Normally, stem cells go through different stages before they fully develop into healthy blood cells, which include red blood cells, white blood cells, and platelets.

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Red blood cells carry oxygen all throughout your body

Mechanism of action image

White blood cells protect your body and fight infections

Mechanism of action image

Platelets help your blood clot to stop bleeding

With acute leukemia, the abnormal leukemia cells (or blasts ) multiply very quickly and take over the space in the bone marrow. This blocks the cells from turning into normal healthy blood cells. Acute lymphoblastic leukemia (or ALL) and acute myeloid leukemia (or AML) are two different types of acute leukemia that stop cells from developing into healthy blood cells and lower your healthy blood cell count.

WHAT IS KMT2Ar?

What is KMT2Ar?

When you were first diagnosed with ALL or AML, your doctor ran a workup of tests See less circle to see the exact type of acute leukemia you have. Part of that workup included genetic testing that can detect the genetic changes, such as mutations and gene rearrangements See less circle , that may have caused your specific type of ALL or AML. The majority of KMT2A rearrangements include translocations—a type of genetic change in which a piece of one chromosome See less circle breaks off and attaches to another chromosome.

KMT2A rearrangements, including translocations,
may play a role in the development of both AML and ALL

In general, AML is more common in adults, and ALL is more common in infants, children, and young adults. But AML and ALL can affect people of any age and gender.

Here’s a breakdown of the percent of people with AML or ALL who may have a KMT2A See less circle gene rearrangement (KMT2Ar):

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Infants

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Children

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Adults

KMT2Ar AML

KMT2Ar AML

KMT2Ar AML

KMT2Ar ALL

KMT2Ar ALL

KMT2Ar ALL

KMT2Ar AML ~35%-60%

KMT2Ar AML ~10%-15%

KMT2Ar AML ~5%-10%

KMT2Ar ALL ~80%

KMT2Ar ALL ~5%-6%

KMT2Ar ALL ~5%-15%

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Actor portrayal.

Until now, there hasn’t been an FDA-approved treatment that targets AML and ALL with a KMT2A translocation in
patients 1 year and older
whose disease has come back
or has not improved after
previous treatment(s)

Until now, there hasn’t been an FDA-approved treatment that targets AML and ALL with a KMT2A translocation in patients 1 year and older whose disease has come back or has not improved after previous treatment(s)

Actor portrayal.

Next: How Revuforj Works

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

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 or 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
  • 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
  • Females who are able to become pregnant should 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 should 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. 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:

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

Your healthcare provider will do blood tests and ECGs before you start and during treatment with Revuforj. 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).


Your healthcare provider will perform a test to make sure that Revuforj is right for you.

It is not known if Revuforj is safe and effective in children less than 1 year of age.


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

Important Safety Information

Important Safety Information

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

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: