Dordaviprone (Modeyso™)

How to Take Dordaviprone (Modeyso™)

This medication comes in a capsule you take by mouth. Take your dose on the same day each week. Be sure to take all of the capsules prescribed at the same time. You should take this medication on an empty stomach: 1 hour before or 3 hours after eating. This medication can be dissolved in apple juice, water, lemonade, or sports drinks and taken as a liquid. 

If you miss a dose, call your provider. If you are within 2 days of your missed dose, you are ok to take the dose. If it has been more than two days, skip the missed dose and take your next dose as planned. If you vomit after taking your dose, do not take an extra dose. Instead, take your next dose as scheduled.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include, but are not limited to, itraconazole, fluconazole, and erythromycin. Be sure to tell your healthcare provider about all medications and supplements you take.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Dordaviprone is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce your co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources if they are available.

Possible Side Effects of Dordaviprone (Modeyso ™)

There are a number of things you can do to manage the side effects of dordaviprone.  Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy, or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Muscle/Joint Pain and Aches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Headache

If you have new headaches or headaches that are getting worse, contact your provider.

Low White Blood Cell Count (Leukopenia)

White blood cells (WBC) help your body fight infection. There are a few kinds of WBC, including:

• Lymphocytes (T cells, B cells, and natural killer [NK] cells): Help fight viruses in your body and make proteins that help your immune system fight infection.
• Neutrophils: Your immune system’s first line of defense. These cells fight infection and inflammation in your body and release cytokines and growth factors to help your immune system.
• Monocytes: Help clean out old or damaged cells in your body.
• Basophils: Help with allergic responses (sneezing, runny nose) by releasing heparin and histamine. They also help fight parasites and make cytokines to fight infections.
• Eosinophils: Help find and kill parasites and cancer cells. They also help basophils with allergic responses.

Leukopenia happens when there are low levels of one or more of these white blood cells.

 While you are having cancer treatment, your WBC count can drop, putting you at a higher risk of an infection. Your provider will want to know if you have a fever, which is often a temperature greater than 101°F/ 38.3°C. Your provider will tell you at what temperature to call them. Also, call your provider if you have a sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal. 

Tips to prevent infection: 

• Hand washing: both yours and your visitors is the best way to prevent the spread of infection. 
• Avoid large crowds and people who are sick (those who have a cold, fever, or cough, or live with someone with these symptoms). 
• When working outside, wear clothes that protect you, like long pants and gloves. 
• Do not handle pet waste. 
• Keep all cuts and scratches clean. 
• Shower or bathe daily. 
• Brush your teeth at least twice a day. 
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails. 
• Ask your providers before scheduling dental appointments or procedures. 

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Important but Less Common Side Effects

• Hypersensitivity: In some cases, patients can have an allergic reaction to this medication. Signs of a reaction can include: shortness of breath or difficulty breathing, swelling of the lips or throat or difficulty swallowing. Seek medical help right away or call 911 if these symptoms develop. Depending on the severity of your reaction, you may still be able to receive the medication with a pre-medication to prevent a reaction.
• QT prolongation: This medication can cause slow or abnormal heartbeats or an abnormal heart rhythm called QT prolongation. Your provider may ask you to have an EKG before you start treatment and during treatment. Notify your oncology care team right away if you feel abnormal heartbeats or if you feel dizzy or faint.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Use effective birth control during and for one month after treatment.  Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while taking this medication or for 1 week after your last dose.