Infigratinib (in-fig-RA-ti-nib)

Treats bile duct cancer.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine at least 1 hour before or 2 hours after food at about the same time each day.
• Swallow the capsule whole with water. Do not crush, break, chew, or dissolve it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it is less than 4 hours on the same day, take it as soon as you remember. If more than 4 hours have passed, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how infigratinib works. Tell your doctor if you are using itraconazole or rifampin.
• Tell your doctor if you are using a stomach medicine (including lansoprazole). Take this medicine at least 2 hours before or 2 hours after taking an antacid or at least 2 hours before or 10 hours after taking an acid reducer (including H2 blocker).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 month after the last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or eye or vision problems.
• This medicine may cause eye or vision problems, including dry or swollen eyes. You may use artificial tear substitutes, hydrating, or lubricating eye gels to help prevent or treat dry eyes.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or changes in vision, dry eyes
• Bone pain, loss of appetite, trouble breathing, unusual tiredness or weakness
• Numbness and tingling around the mouth, fingertips, or feet
• Redness, swelling, pain, ulcers, or scaling of the skin on the hands and feet
• Stomach pain or cramps, confusion, seizures, uneven heartbeat, mood or mental changes

If you notice these less serious side effects, talk with your doctor:

• Changes in fingernails or toenails
• Constipation, diarrhea, loss of appetite, nausea, vomiting
• Dry skin
• Hair loss
• Joint, arm, or leg pain
• Loss of taste, changes in taste, dry mouth
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088