Infigratinib

Infigratinib is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued.

Because this drug is no longer available in the U.S. market, this document is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information.

Infigratinib is used in adults who have received previous therapy to treat a certain type of cholangiocarcinoma (bile duct cancer) that has spread to nearby tissues or other parts of the body and cannot be removed by surgery. Infigratinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Infigratinib comes as a capsule to take by mouth. It is usually taken once daily on an empty stomach (at least 1 hour before or at least 2 hours after food) for the first 21 days of a 28-day cycle. The cycle may be repeated as recommended by your doctor. Take infigratinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take infigratinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not split, chew, dissolve, or open them.

If you vomit after taking infigratinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with infigratinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking infigratinib,

• tell your doctor and pharmacist if you are allergic to infigratinib, any other medications, or any of the ingredients in infigratinib capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking infigratinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums), or calcium carbonate and magnesium (Rolaids), take infigratinib 2 hours before or 2 hours after you take the antacid. If you are taking H₂ blockers, such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac), take infigratinib 2 hours before or 10 hours after you take the H₂ blocker.
• the following nonprescription products may interact with infigratinib: proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking infigratinib. Do not start any of these medications while taking infigratinib without discussing with your healthcare provider.
• tell your doctor if you have vision or eye problems or if you have or ever had liver or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for at least 1 month after your final dose. If you are a male, you and your partner should use birth control during your treatment and for 1 month after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking infigratinib, call your doctor immediately. Infigratinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking infigratinib and for 1 month after your final dose.
• you should know that this medication may cause dry eyes. Your doctor may tell you to use artificial tears or lubricant eye drops during your treatment with infigratinib.

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

Take the missed dose as soon as you remember it, with a meal. However, if it has been more than 4 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Infigratinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• constipation
• loss of appetite
• changes in taste
• heartburn or indigestion
• stomach pain
• sores on the lips, mouth, or throat
• dry mouth and/or skin
• nail disorders
• hair loss
• headache
• fatigue
• swelling of hands, feet, legs or ankles
• pain in joints, arms, or legs
• nose bleeds

Some side effects can be serious. If you experience any of these symptoms , call your doctor immediately or get emergency medical treatment:

• blurred vision, floaters in the eye, seeing flashes of light, or other changes in vision
• muscle cramps, numbness, or tingling around the mouth
• fever, chills, or other signs of infection
• blistering and peeling skin

Infigratinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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