Tovorafenib is used in adults and children at least 6 months old for the treatment of brain tumors called gliomas.

Tovorafenib is given after other treatments did not work or stopped working.

Your doctor will make sure you have the correct tumor type to be treated with tovorafenib.

Tovorafenib may also be used for purposes not listed in this medication guide.

Tell your doctor if you have or have ever had:

• bleeding problems;
• skin problems, such as rash; or
• liver disease.

Tovorafenib can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Tovorafenib can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

Tovorafenib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 28 days after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 2 weeks after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Tovorafenib may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Use Tovorafenib (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• acne, redness, swelling, peeling, or tenderness of hands or feet;
• any bleeding that will not stop;
• bleeding inside your body--weakness, dizziness; pink or brown urine; abnormal vaginal bleeding; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• tiredness, headache;
• constipation, nausea, vomiting;
• cold symptoms such as stuffy nose, sneezing, sore throat, viral infection, fever;
• skin rash, dry skin, acne, hair color changes; or
• abnormal lab results.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tovorafenib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.