Futibatinib is used in adults to treat bile duct cancer that has spread (metastatic) or cannot be removed by surgery:

• who have already received another treatment; and

• whose tumor has an abnormal "FGFR2" gene.

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

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take futibatinib once a day with or without food at about the same time.

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

If you vomit shortly after taking futibatinib, do not take another dose. Take your next dose as scheduled.

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

You will need to see an eye specialist before you start using futibatinib, every 2 months for the first 6 months, and then every 3 months thereafter while you are using this medicine.

You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Your blood will need to be tested during treatment with futibatinib.

You should use artificial tears, or lubricating eye gels during treatment with futibatinib.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

Usual dose: 20 mg (five 4 mg tablets) taken orally once daily

Comments:
-Confirm the presence of an FGFR2 gene fusion or other rearrangement prior to initiation of treatment.
-Treatment to be continued until disease progression or unacceptable toxicity occurs.

Use: Patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Tell your doctor if you have:

• vision or eye problems.

Futibatinib can harm an unborn baby if the mother or the father is using futibatinib.

• 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 1 week 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 1 week after your last dose.

• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

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

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).

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

Grapefruit may interact with futibatinib and cause side effects. Avoid consuming grapefruit products.

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

Futibatinib may cause serious side effects. Call your doctor at once if you have:

• changes in your vision, including blurred vision, seeing flashes of light, or black spots;

• muscle cramps; or

• numbness or tingling feeling around your mouth.

Common side effects of futibatinib may include:

• stomach pain, nausea, vomiting, constipation, diarrhea, loss of appetite;

• dry mouth, skin, or eye;

• pain and burning when you urinate;

• tiredness or weakness;

• redness, swelling, pain, or blisters on the palms of your hands or the soles of your feet;

• muscle or joint pain;

• changes in your sense of taste;

• change in appearance or color of nails;

• hair loss;

• abnormal lab tests;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky;

• low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss;

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

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.

Tell your doctor about all your other medicines, especially:

• itraconazole; or

• rifampin.

This list is not complete. Other drugs may affect futibatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.

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.