Vorasidenib

Vorasidenib is used to treat adult and pediatric patients 12 years and older with certain types of astrocytoma or oligodendroglioma that have not improved with surgery. Vorasidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitors. It works by blocking enzymes that cause the tumor to grow.

Vorasidenib comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take vorasidenib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vorasidenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may decrease your dose or temporarily or permanently stop your treatment of vorasidenib during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take vorasidenib even if you feel well. Do not stop taking vorasidenib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vorasidenib,

• tell your doctor and pharmacist if you are allergic to vorasidenib, any other medications, or any of the ingredients in vorasidenib. Ask your pharmacist for a list of the ingredients.
• some medications should not be taken with vorasidenib. Other medications may cause dosing changes or extra monitoring when taken with vorasidenib. Make sure you have discussed any medications you are currently taking or plan to take before starting vorasidenib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking vorasidenib, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with vorasidenib: St John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking vorasidenib. Do not start any of these medications while taking vorasidenib without discussing with your healthcare provider.
• you should know that vorasidenib may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking vorasidenib. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• tell your doctor if you have or have ever had liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You should not become pregnant while you are taking vorasidenib. If you are female, you will need to take a pregnancy test before you start treatment and you should use a reliable method of birth control while taking vorasidenib and for at least 3 months after your final dose. If you are a male, you and your female partner should use effective birth control while you are taking vorasidenib and for 3 months after your final dose. If you or your partner becomes pregnant while taking vorasidenib call your doctor immediately. Vorasidenib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking vorasidenib and for 2 months after your final dose.
• Vorasidenib may impair fertility in males and females based on studies in animals.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it if it is within 6 hours of your scheduled dose. However, if it is missed by more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you vomit after taking a dose, do not take another dose. Just take the next dose at the scheduled time on the following day.

Vorasidenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• headache
• muscle or joint pain
• diarrhea
• nausea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• seizures
• lack of energy, tiredness or weakness, loss of appetite, dark urine, yellowing of your skin or eyes, flu-like symptoms, pain in the upper right part of your stomach

Vorasidenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) packet that comes in the container. Do not swallow the desiccant packet.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to vorasidenib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Voranigo^®