USEFUL INFORMATION

Erdaini (erdafitinib) tablets

What is ERDAFITINIB?

ERDAFITINIB 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.

Test your cancer for certain types of abnormal FGFR genes and make sure that ERDAFITINIB is right for you.

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

Before taking ERDAFITINIB make sure about all of your medical conditions, including if you:

• have vision or eye problems.

• are pregnant or plan to become pregnant. ERDAFITINIB can harm your unborn baby. You should not become pregnant during treatment with ERDAFITINIB.

Females who can become pregnant:

Your healthcare provider may do a pregnancy test before you start treatment with ERDAFITINIB.

You should use effective birth control during treatment and for 1 month after the last dose of ERDAFITINIB. Talk to your healthcare provider about birth control methods that may be right for you.

Males with female partners who can become pregnant:

You should use effective birth control when sexually active during treatment with ERDAFITINIB and for 1 month after the last dose. Do not breastfeed during treatment and for 1 month after the last dose of ERDAFITINIB.

How should I take ERDAFITINIB?

• Take ERDAFITINIB exactly as your healthcare provider tells you.

• Take ERDAFITINIB 1 time each day.

• Swallow ERDAFITINIB tablets whole with or without food.

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

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

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

What are the possible side effects of ERDAFITINIB?

ERDAFITINIB may cause serious side effects, including:

• Eye problems. Eye problems are common with ERDAFITINIB 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 ERDAFITINIB, your healthcare provider will send you to see an eye specialist.

• High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with ERDAFITINIB but can also be serious. High levels of phosphate in your blood may lead to build-up of minerals such as calcium in different tissues in your body. Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with ERDAFITINIB, and then monthly.

Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change or stop treatment with ERDAFITINIB if needed.

Tell your healthcare provider right away if you develop painful skin lesions, any muscle cramps, or numbness or tingling around your mouth.

The most common side effects of ERDAFITINIB 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.

Call your healthcare provider for medical advice about side effects.

How should I store ERDAFITINIB?

• Store ERDAFITINIB tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ERDAFITINIB and all medicines out of the reach of children.