Erdafitinib is used to treat certain types of urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that spread to nearby tissues or other parts of the body that cannot be removed by surgery and has worsened during or after being treated with other chemotherapy medications. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Erdafitinib comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take erdafitinib 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 erdafitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking erdafitinib, 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. Be sure to tell your doctor how you are feeling during your treatment with erdafitinib. Do not stop taking erdafitinib without talking to your doctor.

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 erdafitinib,

• tell your doctor and pharmacist if you are allergic to erdafitinib, any other medications, or any of the ingredients in erdafitinib tablets. Ask your pharmacist or check the Medication Guide 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 erdafitinib. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever been told that you have high blood levels of phosphorus or if you have or have ever had eye or vision problems, or kidney or liver disease.
• 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 1 month after your final dose. If you are a male, you and your partner should use birth control during your treatment with erdafitinib 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 erdafitinib, call your doctor immediately. Erdafitinib may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking erdafitinib and for 1 month after the final dose.
• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of taking erdafitinib.
• you should know that this medication may cause dry eyes and other eye problems, which may be serious. Your doctor may tell you to use artificial tears or lubricant eye drops during your treatment with erdafitinib.

Your doctor may instruct you to follow a low-phosphorus diet. Follow these directions carefully. Talk to your doctor about foods that contain high amounts of phosphorus.

If you remember the missed dose on the day that you were supposed to take it, take the missed dose as soon as you remember it on that day. However, if you do not remember the missed dose until the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• nausea
• diarrhea
• vomiting
• constipation
• sores on lips, mouth, or throat
• dry mouth
• changes in taste
• abdominal pain
• decreased appetite
• weight loss
• unusual hair thinning or hair loss
• fever
• muscle or joint pain
• burning during urination
• fatigue or tiredness
• shortness of breath

Some side effects can be serious. If you experience any of these symptoms, stop taking erdafitinib and call your doctor immediately:

• blurred vision, loss of vision, or other visual changes
• nail problems or changes
• itchy, dry, painful, or cracked skin
• rash
• swelling, pain, redness, or peeling of skin on the palms and soles of the feet
• muscle cramps, numbness, or tingling around the mouth

Erdafitinib 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 (http://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. http://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 (http://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, eye doctor, and the laboratory. Your doctor will order certain lab tests to check your body’s response to erdafitinib. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with erdafitinib.

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.

• Balversa^®