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Med Guide/IFU  |  Full Prescribing Information

Med Guide/IFU

Full Prescribing Information

Important Safety Information

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Revuforj® (revumenib) Logo

A prescription medicine used to treat 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)
  • 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

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.

Red blood cells in vein Red blood cells in vein Red blood cells in vein Red blood cells in vein Red blood cells in vein Red blood cells in vein Red blood cells in vein Red blood cells in vein

Red blood cells carry oxygen all throughout your body

White blood cells protect and fight White blood cells protect and fight

White blood cells protect your body and fight infections

Platelets help blood clot Platelets help blood clot Platelets help blood clot Platelets help blood clot

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.

Red blood cells in vein

Red blood cells carry oxygen all throughout your body

White blood cells protect and fight

White blood cells protect your body and fight infections

Platelets help blood clot

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.

Learn more about NPM1 mutations

Learn more about KMT2A rearrangements

WHAT IS NPM1m?

What is NPM1m?

When you were first diagnosed with AML, your doctor ran a workup of tests See less circle 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 genetic changes, such as mutations, that may have caused your specific type of AML. NPM1 mutations See less circle are the most common type of genetic change in AML.

NPM1 mutations can play an important role
in the development of AML

In general, AML is more common in older adults, but it can affect people of any age and gender. Around 1 in 3 adults with AML have an NPM1 See less circle mutation.

Here’s a breakdown of the percent of people with AML who may have an NPM1 mutation (NPM1m):

Female pediatric acute leukemia patient icon

Children

Adult female acute leukemia patient icon

Adults

~30%

~6%-8%

Image of a woman making a square with her hands

Actor portrayal.

Learn more about
how Revuforj works
to target AML with
an NPM1 mutation

Actor portrayal.

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 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):

Young child pediatric acute leukemia patient icon

Infants

Male pediatric acute leukemia patient icon

Children

Female adult acute leukemia patient icon

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%

Image of a woman making a square with her hands

Actor portrayal.

Learn more about
how Revuforj works
to target acute leukemia with
a KMT2A translocation

Learn more about how Revuforj works to target acute leukemia with a KMT2A translocation

Actor portrayal.

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 medicines 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

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: