Modeyso (Oral)
Dordaviprone is used to treat adults and children at least 1 year old with a certain type of brain tumor called diffuse midline glioma.
Dordaviprone is given after other treatments did not work or stopped working.
Your doctor will make sure you have the correct tumor type to be treated with dordaviprone.
Dordaviprone may also be used for purposes not listed in this medication guide.
uses
What is Modeyso (Oral) used for?
- Malignant Glioma
warnings
What is the most important information I should know about Modeyso (Oral)?
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 this medicine.
- 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.
Side Effects
What are the side effects of Modeyso (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
You may feel faint while taking dordaviprone. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.
Your cancer treatments may be reduced, delayed, or permanently discontinued if you have certain side effects.
Common side effects 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.
Pregnancy & Breastfeeding
Can I take Modeyso (Oral) if I’m pregnant or breastfeeding?
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
Interactions
What drugs and food should I avoid while taking Modeyso (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Modeyso (Oral)?
Use Modeyso (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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 make sure dordaviprone is the right treatment for you.
Take dordaviprone once each week on the same day and at the same time.
Take 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 the medicine as soon as you remember and stay on your original schedule, but skip the missed dose and use your next dose at the regular time if you are more than 2 days late for the dose. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Modeyso (Oral)?
Images
DDP 125, CMRX
Color: white
Shape: capsule
Imprint: DDP 125, CMRX