Brand Name(s):

Balversa^®

WHY is this medicine prescribed?

Erdafitinib is used to treat 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.

HOW should this medicine be used?

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.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

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. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporonox, Onmel, Tolsura), and ketoconazole; carbamazepine (Carbatrol, Equetro, Tegretol, others); clarithromycin; medications for human immunodeficiency virus (HIV) such as efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra, in Viekira), and saquinavir (Fortovase, Invirase); metformin (Fortamet, Glucophage, in Actoplus Met, others); nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek;), rifampin (Rifadin, Rimactane, in Rifater); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with erdafitinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
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.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://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.

What OTHER INFORMATION should I know?

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.

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.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2019.