Dordaviprone (By mouth)

Dordaviprone (dor-DA-vip-rone)

Treats diffuse midline glioma (brain tumor).

Brand Name(s):

Modeyso

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Capsule:
  • Swallow the capsule whole. If you cannot swallow the capsule whole, you may dissolve it in sports drink, apple juice, lemonade, or water.
  • Wash your hands before and after using this medicine.
  • Carefully open the capsule by gently pulling and twisting both ends. Slowly empty the contents into the cup. Gently tap the shell to remove any remaining powder.
  • Add 1 to 2 tablespoons (about 15 to 30 mL) of liquid into the cup. Gently swirl the liquid before taking or giving the mixture until no large chunks of powder remain. The mixture may look cloudy.
  • Give or take the mixture right away or within 2 hours of preparing it. Add another 15 to 30 mL of liquid into the cup and swirl it around to rinse any remaining medicine. Give or take it right away to make sure no medicine is left.
  • You may also give this medicine using an oral dosing syringe or through a feeding tube.
  • After taking or giving this medicine, throw away empty capsule shells and rinse the cup with warm water. Do not save or reuse empty capsules.
• Take this medicine on an empty stomach (at least 1 hour before or 3 hours after eating food).
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is 2 days or less, take it as soon as you remember and take the next dose at your regular dosing time. If it is more than 2 days, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.
• If you vomit after taking the medicine, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away unused mixture within 2 hours after preparing it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicine can affect how dordaviprione works. Tell your doctor if you are using efavirenz, erythromycin, fluconazole, itraconazole, rifampin, or medicine to treat heart rhythm problems.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after your last dose. Males who are taking this medicine with female partners who can become pregnant must use effective birth control during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 week after the last dose.
• Tell your doctor if you kidney disease, liver disease, heart failure, or heart rhythm problems.
• This medicine may cause heart rhythm problems, including QT prolongation and torsades de pointes.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Muscle or bone pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 10/4/2025