futibatinib

What is the most important information I should know about futibatinib?

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

What is futibatinib?

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.

What should I discuss with my healthcare provider before taking futibatinib?

Tell your doctor if you have:

• vision or eye problems.

• 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.

How should I take futibatinib?

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.

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.

What happens if I miss a 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.

What happens if I overdose?

What should I avoid while taking futibatinib?

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

What are the possible side effects of futibatinib?

• 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 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.

What other drugs will affect futibatinib?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about futibatinib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 1.02. Revision date: 7/12/2023.