Tovorafenib

Tovorafenib is used to treat certain types of low grade glioma that has not responded to other therapies or has returned in children 6 months of age or older. Tovorafenib is in a class of medications called kinase inhibitors. It works by stopping the tumor growth.

Tovorafenib comes as a tablet or powder for suspension (liquid) to take by mouth. It is usually taken with or without food once a week. Take tovorafenib on the same day and at around the same time each week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tovorafenib 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.

If using the suspension, add 14 mL of room temperature water to the bottle of tovorafenib powder just prior to giving the dose. Do this for each of the bottles needed to get the correct dose of tovorafenib prescribed by your doctor. The suspension should be given right after mixing by either using a syringe to give by mouth or by nasogastric tube. If the suspension is not given within 15 minutes after adding water, it must be thrown away.

Your doctor will decide how long you should take tovorafenib.

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

Before taking tovorafenib,

• tell your doctor and pharmacist if you are allergic to tovorafenib, any other medications, or any of the ingredients in tovorafenib tablet or tovorafenib powder for suspension. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with tovorafenib. Other medications may cause dosing changes or extra monitoring when taken with tovorafenib. Make sure you have discussed any medications you are currently taking or plan to take before starting tovorafenib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking tovorafenib, please get the advice of your doctor or pharmacist.
• you should know that tovorafenib 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 tovorafenib. 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 or any other type of cancer.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tovorafenib, call your doctor immediately. Tovorafenib should not be taken in pregnant women. It may cause harm to the fetus. Women who are able to become pregnant should have a negative pregnancy test before starting treatment with tovorafenib. Women who are able to become pregnant should use appropriate contraception during treatment with tovorafenib and for 28 days after. Your doctor will talk to you about contraception that will work for you. Males with female partners able to become pregnant should use appropriate contraception during tovorafenib treatment and for 2 weeks after. Do not breastfeed during tovorafenib treatment or for 2 weeks after.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Tovorafenib may make your skin sensitive to sunlight.
• you should know that tovorafenib has caused hemorrhage (bleeding), potentially life-threatening. Seek emergency care or call your doctor right away if you have any of the following symptoms: headache, dizziness or feeling weak; coughing up blood or blood clots; vomiting blood or vomit looking like coffee grounds; or red or tarry-looking black stools.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss a dose and remember within 3 days of when you were supposed to take it, take the missed dose as soon as possible and take the next dose on the regularly scheduled day. If it has been more than 3 days since you were supposed to take it, skip the missed dose and take the next dose on the regular scheduled day. If vomiting occurs after taking a dose, take another dose.

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

• rash
• hair color changes
• tiredness
• vomiting
• headache
• fever, cough, congestion
• dry skin
• constipation
• nausea
• acne

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

• rash, skin bumps, blisters, peeling or red, irritated skin
• pain in right side of stomach, yellowing of skin or whites of eyes, dark urine, nausea or vomiting, loss of appetite, tiredness, bruising, bleeding

Tovorafenib may cause growth retardation (delay in growth). Talk to your doctor about the risks of taking this medication.

Tovorafenib 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). Tablets should stay in the blister pack they come in until it is time to take your dose.

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 tovorafenib.

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.

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