Erdafitinib Tablets

What is this medication?

ERDAFITINIB (ER da FI ti nib) treats bladder cancer and kidney 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): Balversa

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
• Vision problems
• An unusual or allergic reaction to erdafitinib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice.

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 on the same day. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

If you vomit a dose, 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?

Do not take this medication with any of the following:

• Dofetilide

This medication may also interact with the following:

• Certain antibiotics, such as erythromycin, clarithromycin
• Certain antifungals, such as ketoconazole, itraconazole, posaconazole
• Certain antivirals for HIV or hepatitis
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications that can change blood phosphorous levels
• Grapefruit or grapefruit juice
• St. John's wort

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?

Your condition will be monitored carefully while you are receiving 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.

This medication may cause dry eyes and blurred vision. 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.

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.

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.

Your blood phosphorous levels will be monitored. Do not take more than 600 to 800 mg per day of phosphate. Tell your care team if you have painful skin lesions, any muscle cramps, or numbness and tingling around your mouth.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 month after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 month after the last dose.

Do not breastfeed while taking this medication and for 1 month after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

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
• Diarrhea
• Dryness or irritation of the eyes, lips, mouth, or nose
• Hair loss
• Loss of appetite with weight loss
• Pain, redness, or swelling with sores inside the mouth or throat
• Unusual weakness or fatigue

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 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, take 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.