Infigratinib Oral Capsules

What is this medication?

INFIGRATINIB (IN fig RA ti nib) targets proteins in cancer cells and stops the cancer cells from growing. It treats bile duct cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TRUSELTIQ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• eye disease
• high levels of phosphorous in the blood
• kidney disease
• liver disease
• an unusual or allergic reaction to infigratinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. Take it on an empty stomach, at least 1 hour before and 2 hours after food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

This medicine is taken in "cycles." There will be days you do not take it. Talk to your health care provider if you have questions about when to take your medicine. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose by 4 hours or more, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

This medicine may interact with the following medications:

• certain antibiotics like erythromycin or clarithromycin
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• grapefruit juice
• rifampin
• stomach acid blockers like cimetidine, famotidine, ranitidine, lansoprazole, omeprazole, or pantoprazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medicine may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your health care provider tells you to stop.

You may need blood work while you are taking this medicine.

Your vision may be tested before and during use of this medicine.

Tell your health care provider right away if you have any change in your eyesight.

This medicine may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your health care provider if the problem does not go away or is severe.

Do not become pregnant while taking this medicine or for 1 month after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 month after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 1 month after stopping it.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care provider. These medicines may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

This medicine can increase cholesterol and triglyceride levels and decrease HDL (the good cholesterol) levels. Your health care provider may check your cholesterol. It may be necessary to change your diet or take new prescription medicines to help lower cholesterol. Alcohol can increase the risk of high cholesterol. Avoid alcoholic drinks while you are taking this medicine.

This medicine may cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• blurred vision OR changes in vision
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• muscle cramps, numbness, or tingling around the mouth
• redness, blistering, peeling, bleeding, or swelling of the skin on the palms of your hands or soles of your feet
• unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• change in taste
• chapped lips
• constipation
• diarrhea
• dry eyes, mouth, or skin
• hair loss
• increase in cholesterol levels
• joint pain
• mouth sores
• nail changes

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.