Erdafitinib (er-da-FI-ti-nib)

Treats bladder cancer.

Brand Name(s):

Balversa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You may use artificial tear substitutes or hydrating or lubricating eye gels or ointments, at least every 2 hours during waking hours to prevent or treat dry eyes.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how erdafitinib works. Tell your doctor if you are using carbamazepine, fluconazole, itraconazole, metformin, or rifampicin.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for 1 month after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, eye problems, or an electrolyte imbalance.
• This medicine may cause eye or vision problems.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Talk with your doctor before using this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor may also want your eyes be checked by an ophthalmologist (eye doctor).
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or changes in vision, dry eyes
• Muscle cramps in the hands, arms, feet, legs, or face, painful skin rash or lump
• Numbness and tingling around the mouth, fingertips, or feet
• Stomach pain or cramps, confusion, seizures, trouble breathing, uneven heartbeat, mood or mental changes
• Redness, soreness, discoloration, or loosening of the fingernails or toenails (continuing and intolerable)
• Redness, swelling, scaling, pain, or tingling of the hands and feet (continuing and intolerable)

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting
• Dry skin
• Hair loss
• Joint or muscle pain
• Loss of taste, changes in taste, dry mouth, decreased appetite
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088