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Overview: Modeyso is a medicine that is taken by mouth to treat certain people with a type of glioma. Tiredness, headache, and nausea are common side effects. If you vomit after taking Modeyso, do not take another dose. Get emergency help if you faint, feel dizzy, have trouble breathing, or notice any changes in your heartbeat. Talk with your health care provider before you start or stop any prescription or over-the-counter (OTC) medicine or supplement.

Uses

What is Modeyso used for?

Modeyso (dordaviprone) is commonly used to treat certain people with a type of glioma.

Modeyso may also be used for other conditions as determined by your health care provider.

How does Modeyso work (mechanism of action)?

Some types of glioma have a mutation that can be found through testing. Gliomas with this mutation have too much of a protein that is involved with cancer cell growth. Modeyso blocks this protein. Modeyso also activates a different protein, which helps to cause cancer cell death. 

How is Modeyso supplied (dosage forms)?

Modeyso is available as a 125 mg capsule that is taken by mouth.

How should I store Modeyso?

Modeyso should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Modeyso?

The most common side effects of Modeyso are listed below. Tell your health care provider if you have any of these side effects that bother you.

There may be other side effects of Modeyso that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Modeyso?

While less common, the most serious side effects of Modeyso are described below, along with what to do if they happen.

Severe Allergic Reactions. Modeyso may cause allergic reactions, which can be serious. Stop taking Modeyso and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Modesto may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Get emergency help if you have any of the following.

  • Faint
  • Lightheadedness or dizziness
  • Changes in your heart rate or rhythm, such as a fast, pounding, or skipping heartbeat
  • Shortness of breath

Warnings & Precautions

Who should not use Modeyso?

Allergies to Ingredients. People who are allergic to any of the following should not take Modeyso.

  • Dordaviprone
  • Modeyso
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Modeyso.

What should I know about Modeyso before using it?

Do not take Modeyso unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Modeyso with other people, even if they have the same condition as you. It may harm them.

Keep Modeyso out of the reach of children.

Keep all appointments for blood work or heart tests. Your health care provider needs these results to help you take this medicine safely.

Consider using a calendar or app to help you remember when to take Modeyso. You need to take this medicine at the same time on the same day each week.

If you are unable to swallow the capsules, you may open them and mix the contents in liquid like water right before each dose. You must swallow the liquid with Modeyso within 2 hours of making it. If more than 2 hours have passed, throw the mixture away and prepare a new dose. Follow the “Instructions for Use” that comes with Modeyso.

Tell your health care provider if you start or stop any new prescription or over-the-counter (OTC) medicine or supplement. The dose of Modeyso may need to be changed.

If you can get your partner pregnant, use effective birth control like condoms with spermicide during  treatment with Modeyso and for 1 month after your last dose.

Modeyso may make it hard for you to get pregnant or get your partner pregnant. If you may want to have children one day, talk to your health care provider.

What should I tell my health care provider before using Modeyso?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Modeyso is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Modeyso may interact with other medicines and supplements. Before taking Modeyso, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy.  Modeyso may harm an unborn baby. Your health care provider may test you for pregnancy before giving you this medicine. If you can become pregnant, use effective birth control during your treatment with Modeyso and for 1 month after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant. 

Breastfeeding. It is not known if Modeyso passes into breast milk. Do not breastfeed during your treatment with Modeyso and for 1 week after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Modeyso?

For more information about Modeyso, you can call the drugmaker at 866-662-2679.

Interactions

Does Modeyso interact with foods or drinks?

Take Modeyso at least 1 hour before or 3 hours after eating or drinking anything but water.

It is unknown if drinking alcohol will affect Modeyso, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. 

Does Modeyso interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Modeyso.

  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • St. John’s wort, which is a supplement that may be used for depression

Many other medicines may alter the blood levels of Modeyso and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Modeyso. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Modeyso?

If you or someone else has used too much Modeyso, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Modeyso?

If you miss a dose, take it as soon as you remember. If you are late by more than 2 days, skip the missed dose, and only take your next scheduled dose. Do not take double or extra doses. 

If you vomit after taking a dose, do not take another dose. Only take your next scheduled dose.