Revumenib

What it is used for

REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. REVUFORJ is indicated for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.

The most important thing to know

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 during treatment with 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. See "

How to take it

Take REVUFORJ exactly as your healthcare provider tells you to. Do not change your dose or stop taking REVUFORJ unless your healthcare provider tells you to. REVUFORJ tablets come in different strengths. Each strength is a different color. Your healthcare provider may prescribe more than 1 strength of REVUFORJ tablets for you, so it is important that you understand how to take your medicine the right way.

Be sure that you understand exactly how many tablets you need to take, and what strengths to take. Take REVUFORJ 2 times a day at about the same time each day about 12 hours apart. Take REVUFORJ fasted (on an empty stomach) or with a low-fat meal (400 calories, 25% or less fat). Talk to your healthcare provider about examples of low-fat meals that you can eat.

Swallow REVUFORJ tablets whole with a cup of water. Do not cut or chew tablets. If you are unable to swallow tablets, crush the tablets and break them apart in water. See the Instructions for Use for detailed instructions on how to prepare and give REVUFORJ tablets. If you miss a dose of REVUFORJ or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose.

Side effects, and when to stop

" for more information about side effects. What is REVUFORJ? 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). 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 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. Before taking REVUFORJ, tell your healthcare provider about all of 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: o Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with REVUFORJ. o Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with REVUFORJ.

o 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: o Use effective birth control during treatment with REVUFORJ and for 4 months after the last dose of REVUFORJ. o Talk to your healthcare provider about birth control methods you can use during this time.

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 any other 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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Who should not take it

Do not take 2 doses within 12 hours. Return to your normal scheduled dose the following day. What are the possible side effects of REVUFORJ? REVUFORJ may cause serious side effects including: The most common side effects of REVUFORJ include: infections, including bacterial and viral infections 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.

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. These are not all possible side effects of REVUFORJ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storing it

Store REVUFORJ at room temperature between 68°F to 77°F (20°C to 25°C). Store the tablets in the bottle that it comes in until you are ready to take it. The REVUFORJ bottle has a drying agent (desiccant) and child resistant closure. Keep REVUFORJ and all medicines out of reach of children.