MODEYSO is a prescription medicine used to treat adults and children 1 year of age and older with a certain type of brain tumor called diffuse midline glioma that has a specific “H3 K27M” gene mutation and has gotten worse after other treatments.
It is not known if MODEYSO is safe and effective in children less than 1 year of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about MODEYSO?
Before taking MODEYSO, tell your healthcare provider about all of your medical conditions, including if you:
have heart failure or heart rhythm problems, including QT prolongation or long QT syndrome. MODEYSO may increase the risk of heart rhythm problems.
are pregnant or plan to become pregnant. MODEYSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MODEYSO.
Your healthcare provider should check to see if you are pregnant before you begin treatment with MODEYSO.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with MODEYSO, and for 1 month after your last dose.
Males with partners who are able to become pregnant should use effective contraception during treatment with MODEYSO, and for 1 month after your last dose.
are breastfeeding or plan to breastfeed. It is not known if MODEYSO passes into breast milk. Do not breastfeed during treatment with MODEYSO and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including:
prescription and over-the-counter medicines, vitamins, and herbal supplements.
MODEYSO and other medicines may affect the way each other work and may cause serious side effects. You can ask your healthcare provider or pharmacist for a list of medications that interact with MODEYSO.
Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start or stop taking any new medicines without first talking to your healthcare provider.
What are the possible side effects of MODEYSO?
MODEYSO may cause serious side effects, including:
Allergic reactions. Allergic reactions may happen during treatment with MODEYSO and can be severe. Stop taking MODEYSO and get immediate emergency medical help right away if you get any signs or symptoms of allergic reactions, including:
rash
hives
fever
feeling faint or dizzy
wheezing or trouble breathing
swelling of the face or throat
Heart rhythm problems (QTc interval prolongation). MODEYSO can cause changes in the electrical activity of your heart and can increase your chance of getting a type of abnormal heart rhythm, called torsades de pointes, that can lead to sudden death. Before you start treatment and during treatment as needed, your healthcare provider will check your heart using an electrocardiograph (ECG) and check your blood levels of salts called electrolytes. Get emergency medical help right away if you get any signs or symptoms of abnormal heart rhythm, including:
feeling lightheaded or faint
dizziness
fast heartbeat
heart palpitations
shortness of breath
The most common side effects of MODEYSO include:
tiredness
headache
vomiting
nausea
muscle, joint, and bone pain
The most common abnormal blood tests include decreased white blood cells, decreased red blood cells, decreased calcium, and increased liver enzymes.
MODEYSO may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of MODEYSO. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to Jazz Pharmaceuticals at 1-866-662-2679.
