infigratinib

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

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

What is infigratinib?

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 this medicine.

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

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

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.

How should I take infigratinib?

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 the medicine at the same time each day.

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.

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 4 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

What should I avoid while taking infigratinib?

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.

What are the possible side effects of infigratinib?

• 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 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.

What other drugs will affect infigratinib?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about infigratinib.