Modeyso - Dordaviprone Capsules

What is this medication?

DORDAVIPRONE (dor DA vip rone) treats brain cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): MODEYSO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart or blood vessel conditions
• Irregular heartbeat or rhythm
• Low levels of calcium, potassium, or magnesium in your blood
• Slow heartbeat
• An unusual or allergic reaction to dordaviprone, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label on the same day of each week. Do not cut, crush, or chew this medication. Swallow the capsules whole. You may open the capsule and mix the contents with 15 to 30 mL of liquid, such as sports drink, apple juice, lemonade, or water. Swallow the mixture right away. Take it on an empty stomach, at least 1 hour before or 3 hours after food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can, unless it is more than 2 days late. If it is more than 2 days late, skip that dose. Take your next dose on your normal scheduled day. Do not take double or extra doses.

If you vomit after taking your dose, do not take another dose. Take your next dose at your normal scheduled time.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Lefamulin
• Pimozide
• Some medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Some medications for HIV or hepatitis, such as lopinavir; ritonavir or saquinavir
• Thioridazine

Other drug interactions:

• Other medications that cause heart rhythm changes
• Grapefruit or grapefruit juice
• Supplements, such as St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

Talk to your care team if you or your partner may be pregnant. Serious fetal side effects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 month after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 month after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.