Class Name(s):

• 10:00 Antineoplastic Agents

Brand Name(s):

• Modeyso^®

WHY is this medicine prescribed?

Dordaviprone is used to treat certain forms of glioma(a brain tumor that originates in the glial cells, the supportive and protective cells of the brain and spinal cord). Dordaviprone is in a class of medications called protease activators. It works by stopping tumor growth.

HOW should this medicine be used?

Dordaviprone comes as a capsule to take by mouth. Take 1 hour before or 3 hours after eating once weekly. Take dordaviprone on the same day each week.

Take dordaviprone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking a dose of dordaviprone, do not take an additional dose. Take your next dose on the scheduled day and time.

Your healthcare provider will determine how long you should use dordaviprone based on how you are tolerating the medication and how your disease is progressing. Do not stop taking dordaviprone unless told to do so by your healthcare provider.

Swallow the capsules whole; do not split, chew, or crush them. If you are unable to swallow the capsules whole, you may open the capsules and mix with 15 to 30 mL (1 to 2 tablespoonsful) of liquid (sports drink, water, apple juice or lemonade) and swallow all of the liquid mixture within 2 hours of mixing.

Your healthcare provider may adjust your dose based on any side effects you may experience. It is important to talk to your healthcare provider about how you are feeling during treatment.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking dordaviprone,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with dordaviprone. Other medications may cause dosing changes or extra monitoring when taken with dordaviprone. Make sure you have discussed any medications you are currently taking or plan to take before starting dordaviprone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dordaviprone, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with dordaviprone: St. John's Wort, cimetidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking dordaviprone. Do not start any of these medications while taking dordaviprone without discussing with your healthcare provider.
• tell your doctor if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or low levels of potassium in your blood.
• tell your doctor if you are pregnant, or plan to become pregnant. Dordaviprone may cause harm to the fetus and should not be used during pregnancy. You may be asked to take a pregnancy test before starting treatment with dordaviprone. You or your partner should use effective contraception during treatment with dordaviprone and for one month following your final dose of dordaviprone. Talk to your doctor about what forms of contraception would be best for you or your partner.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking dordaviprone and for 1 week after your final dose.
• you should know that dordaviprone may cause fertility problems in men and women. This may affect your ability to produce a child. This does not mean you should not use effective contraception during and after treatment. Talk to your healthcare provider if you have concerns about fertility.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it if it has been less than 2 days since the dose was scheduled. If more than 2 days has passed, skip the missed dose and take the next dose on the scheduled day and time. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dordaviprone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• changes in posture, balance, and stride length
• headache
• paralysis in facial nerves (inability to move or control some facial features)
• weakness on one side of the body
• slurred, unclear or difficulty with speech
• dizziness; coordination or balance issues
• nausea, vomiting, difficulty swallowing, constipation
• muscle or joint pain or weakness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, hives, fever, feeling faint or weak, wheezing, swelling of face or throat
• feeling faint, loss of conciousness, feeling of racing or pounding heart, seizures

Dordaviprone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dordaviprone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2025.