Erdafitinib tablets

What is this medication?

ERDAFITINIB (ER da FI ti nib) treats urothelial cancer. It works by targeting proteins in cancer cells and stopping the cancer cells from growing.

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
• Pregnant or trying to get pregnant
• Breast-feeding

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 regarding 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.

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 called macrolides like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain antifungals called azoles like ketoconazole, itraconazole, or posaconazole
• Certain medications for seizures like carbamazepine, phenobarbital, and 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?

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 can cause dry eyes and blurry 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 from your diet. Tell your care team if you have painful skin lesions, any muscle cramps, or numbness and tingling around your mouth.

Do not become pregnant while taking this medication or for 1 month after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 1 month after stopping it. There is a potential for serious side effects to an unborn child. Talk to your care team for more information. Do not breast-feed an infant while taking this medication or for 1 month after stopping it.

This medication may make it more difficult to get pregnant or father a child. Talk with 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
• Change in vision
• High phosphorous level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, bleeding, or swelling of the skin on the palms of your hands or soles of your feet

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

• Constipation
• Diarrhea
• Dry eyes
• Dry mouth
• Loss of appetite
• Nails separate from the bed or poor formation of the nail
• Nausea
• 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 between 20 and 25 degrees C (68 and 77 degrees F).

Get rid of any unused medication after the expiration date.

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.