Modeyso
Modeyso (dordaviprone) is a protease activator used to treat a rare and aggressive brain tumor called diffuse midline glioma (DMG) with a H3 K27M mutation. It's FDA approved for adults and in children 1 year and older whose cancer has gotten worse after previous treatment. You take it by mouth once a week on an empty stomach. Common side effects include tiredness, headache, and nausea.
What is Modeyso (dordaviprone)?
What is Modeyso (dordaviprone) used for?
- Diffuse midline glioma (DMG) with an H3 K27M mutation that has gotten worse after previous treatment
How Modeyso (dordaviprone) works
Modeyso (dordaviprone) is a protease activator. It turns on a protein called ClpP inside cancer cells, which can trigger cancer cell death and disrupt how the cells make energy.
It also blocks dopamine receptors, which could also help slow cancer cell growth.
Drug facts
| Common Brands | Modeyso |
|---|---|
| Drug Class | Protease activator |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Modeyso (dordaviprone)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Tiredness (34%)
- Headache (32%)
- Rise in liver enzymes (up to 28%)
- Vomiting (24%)
- Nausea (24%)
- Lower white blood cell count (at least 24%)
- Muscle or bone pain (20%)
- Lower calcium (20%)
Less Common Side Effects
- Walking problems
- Facial weakness or numbness
- Trouble speaking
- Dizziness
- Balance problems
- Trouble swallowing
- Constipation
- Rash
- Diarrhea
Modeyso (dordaviprone) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Allergic reaction: hives, rash, wheezing or trouble breathing, swelling of the face or throat, dizziness, fever
- Abnormal heart rhythm: fainting, fast or irregular heartbeat, dizziness, feeling lightheaded, heart palpitations, shortness of breath
The following Modeyso (dordaviprone) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Fatigue
- Headache
- Nausea
- Vomiting
Pros and cons of Modeyso (dordaviprone)
Pros
- First FDA‑approved treatment for H3 K27M‑mutant DMG
- Only need to take once a week
- Capsules can be opened and mixed with certain liquids
- Safe for young children
Cons
- Requires heart and blood tests before and during treatment
- Can affect heart rhythm
- Interacts with many medications
- Not safe in pregnancy
Pharmacist tips for Modeyso (dordaviprone)
- Take Modeyso (dordaviprone) on the same day each week on an empty stomach. Take it at least 1 hour before or 3 hours after eating.
- If you vomit after taking Modeyso (dordaviprone), don’t take another dose. Take your next dose on your usual scheduled day.
- If you miss a dose of Modeyso (dordaviprone) by 1 or 2 days, take it as soon as you remember. If it’s been more than 2 days, skip the missed dose and take your next dose as scheduled.
- Modeyso (dordaviprone) can affect your heart rhythm. Your care team will check an electrocardiogram (ECG or EKG) and electrolytes before you start and sometimes during treatment. Tell them right away if you feel dizzy, faint, or notice a fast or irregular heartbeat.
- Serious allergic reactions can happen with Modeyso (dordaviprone). Get medical help right away if you have symptoms like rash, swelling, trouble breathing, or severe itching.
- Modeyso (dordaviprone) can interact with many medications. Check with your prescriber or pharmacist before starting any new prescription, over-the-counter medication, or supplement.
- Pregnancy: Modeyso (dordaviprone) can harm an unborn baby. Use birth control during treatment and for 1 month after your last dose. Call your care team right away if you or your partner become pregnant.
- Breastfeeding: Don’t breastfeed while taking Modeyso (dordaviprone) or for 1 week after your last dose.
- Storage: Keep Modeyso (dordaviprone) at room temperature in its original bottle. Keep it tightly closed, dry, and out of reach of children and pets.
How to take Modeyso (dordaviprone) if you can’t swallow capsules:
- Open the capsules and empty the contents into 1 to 2 tablespoons of water, apple juice, lemonade, or a sports drink. Stir well before taking.
- Take all of the mixture within 2 hours of preparing it. Don't save it for later.
- After taking your dose, add 1 to 2 more tablespoons (15 to 30 ml) of liquid to the cup and drink it. This helps make sure you get the full dose.
Risks and warnings for Modeyso (dordaviprone)
Modeyso (dordaviprone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reaction
Modeyso (dordaviprone) can cause serious allergic reactions, although they are rare. Symptoms can include hives, rash, wheezing, swelling of the face or throat, dizziness.
Get medical help right away if you notice any of these symptoms after taking this medication. Your care team might have you stop it and provide treatment for the reaction.
Abnormal heart rhythm
- Risk factors: Taking other medications that affect heart rhythm | History of heart rhythm problems | Electrolyte problems | Heart failure | Taking medications that interact with Modeyso (dordaviprone)
Modeyso (dordaviprone) can affect your heart rhythm. In rare cases, this can lead to serious or life-threatening heartbeat problems.
Your care team will check an electrocardiogram (ECG) and electrolytes before you start this medication. They might recheck during treatment, especially if your dose changes or you start medications that interact with Modeyso (dordaviprone). Call your care team or seek urgent care if you faint, feel your heart racing, or have severe dizziness.
Harm to unborn baby
Modeyso (dordaviprone) can harm an unborn baby based on how it works. Because of this risk, women who can become pregnant should use effective birth control during treatment and for 1 month after the last dose.
Men with partners who can become pregnant should also use effective birth control during treatment and for 1 month after the last dose. Tell your care team right away if you or your partner become pregnant while taking this medication.
Modeyso (dordaviprone) dosage
Typical dosage for Modeyso (dordaviprone)
Adults: The typical dose is 625 mg by mouth once weekly.
Children and teens (age 1 to less than 17 years, weighing at least 10 kg)
- 10 kg to less than 12.5 kg: The typical dose is 125 mg by mouth once weekly.
- 12.5 kg to less than 27.5 kg: The typical dose is 250 mg by mouth once weekly.
- 27.5 kg to less than 42.5 kg: The typical dose is 375 mg by mouth once weekly.
- 42.5 kg to less than 52.5 kg: The typical dose is 500 mg by mouth once weekly.
- More than 52.5 kg: The typical dose is 625 mg by mouth once weekly.
Your dose might differ if you have side effects or take other medications that interact with Modeyso (dordaviprone).
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