Futibatinib

Futibatinib is used in adults who have received previous therapy to treat a certain type of cholangiocarcinoma (bile duct cancer) that has spread to nearby tissues or other parts of the body and cannot be removed by surgery. Futibatinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Futibatinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take futibatinib 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 futibatinib 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 you vomit after taking futibatinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with futibatinib.

Futibatinib may cause irritation and dry eyes. You should use artificial tears or lubricant eye drops while on treatment with futibatinib to prevent or treat the dry eyes. Your doctor will order an eye exam before and during treatment with futibatinib to watch for more severe eye problems. Make sure you keep all eye exam appointments.

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 futibatinib,

• tell your doctor and pharmacist if you are allergic to futibatinib, any other medications, or any of the ingredients in futibatinib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking futibatinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have vision or eye problems, diabetes, anemia, history of bleeding disorder, or if you have or ever had kidney or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose. If you are a male, you and your partner should use birth control during your treatment and for 1 month after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking futibatinib, call your doctor immediately. Futibatinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking futibatinib and for 1 week after your final dose.

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

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

Take the missed dose as soon as you remember it. However, if it has been more than 12 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• change in appearance or color of nails
• muscle pain
• constipation
• diarrhea or loose stools
• feeling tired or weak
• dry mouth
• hair loss
• mouth sore
• stomach area pain
• dry skin
• joint pain
• changes in taste
• dry eye
• nausea or vomiting
• decrease in appetite
• difficulty or painful urination, lower back pain, or fever
• redness, swelling, pain or tenderness on the hands or feet

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

• dry or inflamed eyes, increased tears, blurred vision, flashes of light, or seeing black spots
• muscle cramps or numbness or tingling around your mouth

Futibatinib 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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 futibatinib.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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