Revumenib (Revuforj®)

How to take Revumenib

This medication comes in tablet form that you take by mouth twice a day, at about the same time each day. This medication may be taken with or without food. If you are taking it with food, take it with a low-fat meal. Take the tablets whole with a glass of water; do not break, crush or chew the tablets.

If a dose is missed or not taken at the usual time, take the dose as soon as you remember, but at least 12 hours before the next scheduled dose. Return to the normal schedule on the following day. Do not take 2 doses within 12 hours. If you vomit a dose, do not take a replacement dose.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include grapefruit, grapefruit juice, Seville oranges (often used in marmalade), St. John's Wort, itraconazole, erythromycin, fluconazole, rifampin, and diltiazem, among others. Be sure to tell your healthcare provider about all medications and supplements you take.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or Pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw it in the trash.

Where do I get this medication?

Certain cancer medications, including revumenib, are only available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for the distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources if they are available.

Possible Side Effects of Revumenib

There are a number of things you can do to manage the side effects of Revumenib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Differentiation Syndrome

This results from the changes revumenib causes to blood cell production in patients with leukemia. Symptoms of differentiation syndrome include fever (temperature >100.4°F or 38°C), sudden weight gain, bone or joint pain, and fluid build-up around the heart, lungs, and/or chest, causing shortness of breath or difficulty breathing. This syndrome is treated with high doses of steroids (like dexamethasone or prednisone) and diuretics (fluid pills). Your healthcare providers will monitor for these signs or symptoms, but it is also important for you to tell your doctor or nurse promptly if you experience any of these symptoms.

Swelling (Edema)

This medication can cause swelling in the face, especially around the eyes, and extremities (hands, arms, legs, ankles, and feet). The swelling can become uncomfortable. This can also be a sign of other problems, so be sure to notify your oncology care team if you are experiencing any new or worsening swelling.

Low Platelet Count (Thrombocytopenia)/ Bleeding

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums, or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib), etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding the use of these agents and all over-the-counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Diarrhea

Diarrhea can be a serious side effect that can lead to dehydration. Notify your care team if you develop diarrhea.

Your oncology team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts.

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F/38°C), sore throat or cold, shortness of breath, cough, burning with urination, new rash or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bath daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Heart Rhythm Changes

Revumenib can cause changes in the QT interval. The QT interval is a measure of part of your heart rhythm, which is read with an ECG (electrocardiogram). If your QT interval is too long (elongated), it can cause changes to your heart rhythm and, in some cases, can lead to death. Your healthcare team will do an ECG to check for this before starting revumenib, 7 days after starting, with any dose changes and every so often while on the drug.

Abnormal blood levels of potassium and magnesium can make you more at risk for heart rhythm changes, so those blood levels will be monitored as well. Taking this medication with some other medications can elongate your QT interval. It is important to tell your providers about all medications you are taking. If you feel an irregular heartbeat, your heart beating more than normal, or become faint, call your provider or 911 right away.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (potassium, magnesium) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Thyroid Issues

This medication can cause your thyroid to not work as well as it should. If you are more tired than usual, are gaining weight, have constipation, moving slower than normal, or have muscle weakness and cramps let your provider know. Your provider may do blood tests to monitor your thyroid function.

Decrease in Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your nurse about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products, and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce, or dressings. Use seasonings like basil, oregano, or rosemary to add flavor. Bacon, ham, and onion can add flavor to vegetables.

Muscle or Joint Pain/Aches and Headache

Revumenib can cause joint or muscle aches and pains, which can interfere with quality of life. Be sure to talk to your oncology care team if you develop this side effect. Be sure to discuss which pain relievers you can safely take with your oncology team, as these are not without their own side effects.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 4 months after the last dose. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. Do not breastfeed while receiving this medication, or for at least 1 week after the last dose.