Description
Revumenib is used to treat acute leukemia with lysine methyltransferase 2A gene translocation (KMT2A) in patients whose disease has come back or did not respond to previous treatment. Your doctor will perform a test before you take this medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of revumenib in children younger than 1 year of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of revumenib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, heart rhythm problems and swelling), which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Boceprevir
- Bosentan
- Buprenorphine
- Buserelin
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart failure or
- Heart rhythm problems (eg, long QT syndrome)—Use with caution. May make these conditions worse.
- Hypokalemia (low potassium levels in the blood) or
- Hypomagnesemia (low magnesium levels in the blood)—Must be corrected first before using this medicine.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine at the same time each day. You may take this medicine on an empty stomach or with a low-fat meal.
Swallow the tablet whole with a cup of water. Do not cut or chew it.
If you are unable to swallow the tablet whole:
- Add all the tablets to a clean and dry pill crusher. Screw the top of the pill crusher down until it touches the tablets.
- Turn the cap back and forth to crush the tablets. Repeat until all large tablet pieces are broken up. The crushed tablets should be like the consistency of flour.
- Use 2 teaspoons to measure 10 milliliters (mL) of room temperature water and add it into a small cup. Add the crushed tablets into the small cup with 10 mL water. Tap the pill crusher to make sure no more crushed tablet pieces are left.
- Carefully swirl the cup every 30 seconds to 1 minute for a total of 5 minutes. The mixture should look cloudy.
- Draw up the mixture into a 20 mL syringe. Turn the oral syringe upside down and back multiple times before taking or giving the medicine. Take the mixture within 2 hours of mixing.
- Place the tip of the oral syringe into the mouth against the inside of the cheek. Slowly and gently press down on the plunger. Allow the patient to swallow the medicine. Make sure that no medicine is left in the mouth. The patient should remain sitting up straight or standing for 2 to 3 minutes right after receiving the medicine.
- Rinse the cup with another 10 mL of room temperature water and repeat the steps to swirl and draw up the water, and give the water until no medicine is left in the cup.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of acute leukemia:
- Adults and children 1 year of age and older weighing 40 kilograms (kg) or more—160 to 270 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- Children 1 year of age and older weighing less than 40 kg—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 95 to 160 milligrams per square meter (mg/m[2]) of BSA, taken 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- BSA of 1.3 to 1.4 meter squared (m2)—135 to 220 mg 2 times a day.
- BSA of 1.1 to 1.2 m2—110 to 185 mg 2 times a day.
- BSA of 1 m2—100 to 160 mg 2 times a day.
- BSA of 0.8 to 0.9 m2—75 to 135 mg 2 times a day.
- BSA of 0.7 m2—50 to 110 mg 2 times a day.
- BSA of 0.6 m2—50 to 100 mg 2 times a day.
- BSA of 0.5 m2—50 to 75 mg 2 times a day.
- BSA of 0.4 m2—25 to 50 mg 2 times a day.
- Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For treatment of acute leukemia:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.
If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant 7 days before starting treatment. Use an effective form of birth control during treatment and for at least 4 months after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant, tell your doctor right away.
Using this medicine may cause differentiation syndrome, which may be life-threatening. It may occur within 1 day and up to 41 days after treatment with this medicine. Check with your doctor right away if you have agitation, bloating or swelling of the face, arms, hands, lower legs, or feet, blurred vision, coma, confusion, decreased urine output, dizziness, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, sweating, swelling of the face, ankles, or hands, tingling of the hands or feet, trouble breathing, unusual weight gain or loss. Your doctor may give you a steroid medicine (eg, dexamethasone) to help treat these symptoms.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Agitation
- anxiety
- bladder pain
- bleeding gums
- blindness
- bloating
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody eye
- blurred vision or other change in vision
- body aches or pain
- bruise
- burning of stinging of the skin
- chest discomfort, pain, or tightness
- chills
- collection of blood under the skin
- coma
- confusion
- cough
- cough producing mucus
- coughing up blood
- deep, dark purple bruise
- depression
- diarrhea
- difficult, burning, or painful urination
- difficulty in breathing or swallowing
- dilated neck veins
- dizziness or lightheadedness
- ear congestion
- eye pain
- fast heartbeat
- fainting
- fever
- frequent urge to urinate
- headache
- heart murmur
- hostility
- inability to speak
- increase in bone pain
- increased menstrual flow or vaginal bleeding
- irregular heartbeat
- irritability
- itching, pain, redness, swelling, tenderness, warmth on the skin
- lethargy
- loss of appetite
- loss of taste or smell
- loss of voice
- lower back or side pain
- muscle twitching
- nausea
- no blood pressure or pulse
- nosebleeds
- numbness or tingling in the face, arms or legs
- pain, redness, or swelling in the arm or leg
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips, nose, eyes, or sex organs
- pale skin
- paralysis
- persistent bleeding or oozing from puncture sites, mouth, or nose
- prolonged bleeding from cuts
- rapid weight gain
- red or dark brown urine
- red or black, tarry stools
- redness of the eye
- seizures
- sensitivity of the eye to light
- severe cramping
- slurred speech
- small red or purple spots on the skin
- sneezing
- sore throat
- stomach pain
- stopping of the heart
- stuffy or runny nose
- stupor
- swelling of the face, ankles, or hands
- tearing
- temporary blindness
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
- tingling of hands or feet
- trouble speaking, thinking, or walking
- ulcers, sores, or white spots in the mouth
- unconsciousness
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- vomiting of blood or material that looks like coffee grounds
- weakness in the arm and/or leg on one side of the body, sudden and severe
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Arm or leg pain
- back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste bad unusual or unpleasant (after) taste
- constipation
- difficulty in moving
- general feeling of discomfort or illness
- joint pain
- muscle or bone pain
- neck pain
- skin rash
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
