Tovorafenib

Tovorafenib is used in adults and children who are at least 6 months old for treating brain tumors known as gliomas.

Tovorafenib is given when other treatments have not worked or have stopped working.

Your doctor will ensure that you have the right type of tumor to be treated with tovorafenib.

Tovorafenib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow the instructions for mixing and taking the oral suspension. The oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Take tovorafenib by mouth once each week, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid). Measure a dose using the supplied measuring device (not a kitchen spoon).

If you vomit shortly after taking tovorafenib, take another dose again and take your next dose as scheduled.

You will need frequent blood tests to check your liver function.

Using tovorafenib may increase your risk of developing cancer. Ask your doctor about your individual risk.

Store the tablet at room temperature away from moisture and heat. Keep this medicine in the original container.

Store unmixed oral suspension at room temperature.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

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 tovorafenib.

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.

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

Tovorafenib may cause serious side effects. Call your doctor right away 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 stopped permanently if you have certain side effects.

Common side effects of tovorafenib 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.

Take the medicine as soon as you remember, but skip the missed dose if it has been more than 3 days since you missed it. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tovorafenib could make you more likely to get sunburned. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect tovorafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.