Erdafitinib

Erdafitinib is used in adults to treat bladder cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Erdafitinib is used if your cancer has a specific genetic marker (an abnormal "FGFR" gene), and if you have been treated with at least one other cancer medicine that did not work or has stopped working. Your doctor will test you for this gene.

Erdafitinib is not recommended for adults who have not received previous PD-1 or PD-L1 inhibitor treatment.

Erdafitinib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You may take erdafitinib once a day with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit soon after taking erdafitinib, do not take another dose. Take your next dose as scheduled.

Your doctor may recommend using artificial tears or other lubricating eye medication every 2 hours while you are awake. Continue using these medicines for as long as your doctor has prescribed.

Your blood will need to be tested often.

You may need regular vision exams.

Erdafitinib may cause high phosphate levels, and you may need to follow a special diet. Follow all instructions from your doctor or dietitian. Learn about the foods you should eat or avoid.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have ever had problems with your eyes or vision.

You may need to take a negative pregnancy test before starting this treatment.

Both men and women taking erdafitinib should use effective birth control to avoid pregnancy. Erdafitinib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Continue using birth control for at least 1 month after your last dose. Let your doctor know right away if you become pregnant.

Do not breastfeed while taking this medicine, and for at least 1 month after your last dose.

It may be more difficult for you to get pregnant while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Erdafitinib may cause serious side effects. Call your doctor at once if you have:

• vision problems, vision loss;
• eye pain or redness;
• itchy rash, dry skin, or cracks in the skin;
• symptoms of high phosphate levels--numbness or tingling around your mouth, painful skin lesions, or cramps; or
• problems with your fingernails or toenails--pain, bleeding, separation of the nails from the skin (nail bed), unusual breakage, changes in nail color or texture, cracks, or infection around the nails.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of erdafitinib may include:

• dry eyes, vision problems;
• dry mouth, mouth sores;
• hair loss;
• dry skin, problems with your fingernails or toenails;
• redness, swelling, pain, or blisters on the palms of your hands or the soles of your feet;
• tiredness;
• abnormal lab results;
• nausea, loss of appetite;
• diarrhea, constipation; or
• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Urothelial Carcinoma:

Initial dose: 8 mg orally once a dayMaintenance dose: Increase to 9 mg orally once a day if serum phosphate is less than 9 mg/dL and there are no ocular disorders or Grade 2 or higher adverse reactions at 14 to 21 days.Duration of therapy: Until disease progression or unacceptable toxicityComments:-Select patients for therapy based on the presence of susceptible FGFR 3 genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic.-Limitations of use: Use is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.Use: For the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR 3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy

Take the missed dose on the same day you remember it. Take your next dose at the regular time and continue with your once-daily schedule. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• medicines that may change phosphate levels--potassium phosphate supplements, vitamin D supplements, antacids, enemas or laxatives that contain phosphate, and other medicines known to contain phosphate.

This list is not complete. Other drugs may affect erdafitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.