Medication Guide REVUFORJ (REV-you-forge)
(revumenib)
tablets, for oral use |
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What is the most important information I should know about REVUFORJ?
REVUFORJ may cause serious side effects including:
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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:
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- fever
- cough
- shortness of breath
- severe headache
- confusion
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- dizziness or lightheadedness
- fast weight gain
- swelling of arms, legs, neck, groin, or underarm area
- decreased urination
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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.
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| See "What are the possible side effects of REVUFORJ?" 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 translocation (KMT2A) 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. |
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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.
o 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.
o 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.
o 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.
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 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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
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How should I take REVUFORJ?
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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.
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REVUFORJ can be taken fasted or with a low-fat meal.
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Swallow REVUFORJ tablets whole with a cup of water. 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. Do not cut or chew tablets.
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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. Do not take 2 doses within 12 hours. Return to your normal scheduled dose the following day.
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What are the possible side effects of REVUFORJ?
REVUFORJ may cause serious side effects including:
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see “What is the most important information I should know about REVUFORJ?”
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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.
The most common side effects of REVUFORJ include: |
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- bleeding (hemorrhage)
- nausea and vomiting
- muscle pain
- infections, including bacterial and viral infections
- low white blood cell counts with fever
- diarrhea
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- changes in liver function tests
- swelling in the arms and legs
- decreased appetite
- constipation
- tiredness
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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. 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. |
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How should I store REVUFORJ?
- Store REVUFORJ at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep 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. |
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General information about the safe and effective use of REVUFORJ.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REVUFORJ for a condition for which it is not prescribed. Do not give REVUFORJ to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or health professionals for information about REVUFORJ that is written for healthcare professionals. |
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What are the ingredients in REVUFORJ?
Active ingredient: revumenib
Inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide.
The 110 mg tablet also includes yellow iron oxide.
The 160 mg tablet also includes FD&C blue #2/indigo carmine aluminum lake.
Manufactured for: Syndax Pharmaceuticals, Inc., Waltham, MA 02451
REVUFORJ ® is a registered trademark of Syndax Pharmaceuticals, Inc.
Copyright © 2024 Syndax Pharmaceuticals, Inc.
For more information, go to www.revuforj.com or call Syndax at 1-888-539-3REV.
218944-SYND-MG-001
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