【Drug Name】

Name: Erdafitinib Tablets

Product Name: ERDADX

【Specification】

4mg

【Indications】

ERDADX is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery:

• which has a certain type of abnormal “FGFR” gene, and

• who have tried at least one other chemotherapy medicine that contains platinum, and it did not work or is no longer working.

Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure that ERDADX is right for you.

It is not known if ERDADX is safe and effective in children.

【Recommended Dosage】

• Take ERDADX exactly as your healthcare provider tells you.

• Take ERDADX 1 time each day.

• Swallow ERDADX tablets whole with or without food.

• Your healthcare provider may change your dose of ERDADX, temporarily stop or completely stop treatment if you get certain side effects.

• If you miss a dose of ERDADX, take the missed dose as soon as possible on the same day. Take your regular dose of ERDADX the next day. Do not take more ERDADX than prescribed to make up for the missed dose.

• If you vomit after taking ERDADX, do not take another ERDADX tablet. Take your regular dose of ERDADX the next day.

【Side Effects】

• Eye problems. Eye problems are common with ERDADX but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye. Tell your healthcare provider right away if you develop blurred vision, loss of vision or other visual changes. You should use artificial tear substitutes, hydrating or lubricating eye gels or ointments at least every 2 hours during waking hours to help prevent dry eyes. During treatment with ERDADX, your healthcare provider will send you to see an eye specialist.

• High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with ERDADX but can also be serious. Your healthcare provider will check your blood phosphate level between 14  and 21 days after starting treatment with ERDADX, and then monthly, and may change your dose if needed.

The most common side effects of ERDADX include:

• mouth sores

• feeling tired

• change in kidney function

• diarrhea

• dry mouth

• nails separate from the bed or poor formation of the nail

• change in liver function

• low salt (sodium) levels

• decreased appetite

• change in sense of taste

• low red blood cells (anemia)

• dry skin

• dry eyes

• hair loss

• redness, swelling, peeling or tenderness, mainly on the hands or feet (‘hand-foot syndrome’)

• constipation

• stomach (abdominal) pain

• nausea

• muscle pain

Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.

ERDADX may affect fertility in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all possible side effects of ERDADX. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects.

【Storage】

• Store at or below 86°F (30°C).

Keep all medicines out of reach of children.