Infigratinib is used to treat bile duct cancer that has an abnormal "FGFR2" gene and has spread to other parts of the body (metastatic) after other treatment, and cannot be removed with surgery. Your doctor will make sure you have the correct tumor type to be treated with infigratinib.

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

Follow all directions on the label and package. Use exactly as directed.

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

Infigratinib is given in a 28-day treatment cycle and you will take the medicine only on certain days of this cycle.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take the medicine at the same time each day.

Swallow the capsule whole and do not crush, chew, break, or open it. Take with a full glass of water.

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

You may need frequent vision exams. You may need to use artificial tears or lubricating eye gels if you have dry eyes.

Store tablets in the blister pack at room temperature away from moisture and heat.

Usual Adult Dose for Cholangiocarcinoma of biliary tract:

125 mg (one 100 mg capsule and one 25 mg capsule) orally once a day for 21 days on 7 days off of a 28-day cycle

Comments:
-Continue treatment until disease progression or unacceptable toxicity.
-Select patients for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma based on the presence of an FGFR2 fusion or rearrangement.
-Information on FDA-approved test(s) for the detection of FGFR2 fusions or rearrangements in cholangiocarcinoma is available at: http://www.fda.gov/CompanionDiagnostics.

Use: For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test

Tell your doctor if you have ever had:

• problems with your eyes or vision;

• liver disease; or

• kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

Infigratinib can harm an unborn baby if the mother or the father is using infigratinib. Use birth control while using this medicine and for at least 1 month after your last dose.

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

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 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.

Do not drink grapefruit juice or eat grapefruit while taking this medication.

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

Avoid taking an antacid within 2 hours before or after you take infigratinib.

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

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

• eye pain or discomfort;

• vision changes;

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

• numbness, or tingling around your mouth;

• muscle cramps;

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

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

Common side effects of infigratinib may include:

• dry eyes, blurred vision;

• redness or tenderness on your hands or feet;

• dry skin, hair loss, changes in your eyelashes;

• problems with your fingernails or toenails;

• dry mouth, mouth sores, changes in your sense of taste;

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

• feeling weak or tired;

• joint pain; or

• low blood cell counts, high calcium, or other abnormal lab tests.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Take your infigratinib dose 2 hours before or 10 hours after taking an "H2 blocker" stomach acid medicine. This includes cimetidine, famotidine, nizatidine, ranitidine, Pepcid, Tagamet, and Zantac.

Tell your doctor about any medicines you take to reduce stomach acid. This includes esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Nexium, and Prilosec.

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

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with infigratinib. Your doctor will also order certain lab and eye tests before and during your treatment to check your body's response to infigratinib.

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.