Infigratinib Capsules

What is this medication?

INFIGRATINIB (IN fig RA ti nib) treats bile duct cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. 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 care team tells you to stop.

Do not take this medication with grapefruit juice.

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

Talk to your care team about the use of this medication 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, take it as soon as you can unless it is more than 4 hours late. If it is more than 4 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Certain antibiotics, such as erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, or posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Grapefruit juice
• Rifampin
• Stomach acid blockers, such as 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 medication 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 care team tells you to stop.

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

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

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

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

Talk to your care team if you or your partner wish to become pregnant or either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 1 month after stopping it.

Talk to your care team before breast-feeding. Changes to your treatment plan may be needed.

This medication may increase your risk of getting an infection. Call your care team 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 medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications 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 medication.

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

This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth

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

• Change in nail shape, thickness, or color
• Change in taste
• Constipation
• Dry eyes
• Fatigue
• Hair loss
• Joint pain
• Pain, redness, or swelling with sores inside the mouth or throat

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 medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication 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.