Dordaviprone

Dordaviprone is used to treat adults and children who are at least 1 year old with a specific type of brain tumor known as diffuse midline glioma.

Dordaviprone is given when other treatments did not work or are no longer effective.

Your doctor will confirm that you have the right type of tumor to be treated with dordaviprone.

Dordaviprone may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Your doctor will perform tests to ensure dordaviprone is the right treatment for you.

Take dordaviprone once each week on the same day and at the same time.

Take it on an empty stomach, at least 1 hour before or 3 hours after a meal.

Swallow the capsule whole and do not crush, chew, break, or open it unless your doctor tells you to.

If you are unable to swallow the medicine or use a feeding tube, read and carefully follow the instructions provided to you on how to prepare and use dordaviprone. Ask a doctor or pharmacist if you do not understand these instructions.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Do not change your dose or stop using dordaviprone without your doctor's advice.

If you vomit shortly after taking dordaviprone, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests, and your cancer treatments may be delayed based on the results.

Store tightly closed at room temperature, away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• long QT syndrome;
• heart failure or heart rhythm disorder; or
• an electrolyte imbalance (such as low blood levels of potassium, calcium, or magnesium).

Tell your doctor if you recently started, stopped, or plan to change any medicines. Do not start or stop taking any medicines without first talking to your healthcare provider.

Dordaviprone can harm an unborn baby if the mother or the father is using dordaviprone.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 month after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 month after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Dordaviprone may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may feel faint while taking dordaviprone. Call your doctor right away if you experience fast or pounding heartbeats, shortness of breath, or sudden dizziness.

Your cancer treatments may be reduced, delayed, or permanently stopped if you have certain side effects.

Common side effects of dordaviprone may include:

• tiredness;
• headache;
• abnormal blood tests;
• nausea or vomiting;
• muscle or joint pain; or
• bone pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Malignant Glioma:

625 mg orally once a weekDuration of therapy: Until disease progression or unacceptable toxicityUse: For the treatment of patients with diffuse midline glioma harboring an H3 K27M mutation with progressive disease after prior therapy

Usual Pediatric Dose for Malignant Glioma:

1 year and older:-Weight 10 to less than 12.5 kg: 125 mg orally once a week-Weight 12.5 to less than 27.5 kg: 250 mg orally once a week-Weight 27.5 to less than 42.5 kg: 375 mg orally once a week-Weight 42.5 to less than 52.5 kg: 500 mg orally once a week-Weight at least 52.5 kg: 625 mg orally once a weekDuration of Therapy: Until disease progression or unacceptable toxicityComments:-A recommended dosage has not been established for patients weighing less than 10 kg.Use: For the treatment of patients with diffuse midline glioma harboring an H3 K27M mutation with progressive disease after prior therapy

Use the medicine as soon as you remember and continue with your regular schedule. If you are more than 2 days late for your dose, skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Dordaviprone can lead to a serious heart issue. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Sometimes it is not safe to take certain medicines together. Some drugs can change the blood levels of other drugs you take, which may increase side effects or reduce how well the medicines work.

Many drugs can influence dordaviprone, and some drugs should not be taken at the same time. Inform your doctor about all other medicines you are using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential interactions are included here.