Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you:

• are currently experiencing numbness or tingling in your hands or feet

• have a history of high blood sugar or diabetes

• are pregnant or plan to become pregnant. PADCEV can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV

• are breastfeeding or plan to breastfeed. It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of PADCEV

Females who are able to become
pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.

• You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV.

Males with a female sexual partner
who is able to become pregnant:

• If your female partner is pregnant, PADCEV can harm the unborn baby.

• You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will you receive PADCEV?

• PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.

• You will receive your PADCEV over periods of time called cycles.

- Each PADCEV cycle is 28 days.

- You will receive PADCEV on days 1, 8 and 15 of every cycle.

• Your healthcare provider will decide how many treatment cycles you need.

• Your healthcare provider may do blood tests regularly during treatment with PADCEV.

• High Blood Sugar (hyperglycemia). You can develop high blood sugar during treatment with PADCEV. Tell your healthcare provider right away if you have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, nausea, vomiting, or stomach pain.

• Peripheral neuropathy. While receiving PADCEV you may experience nerve problems called peripheral neuropathy. Tell your healthcare provider right away if you experience numbness or tingling in your hands or feet, or muscle weakness.

• Eye problems. You can develop certain eye problems while receiving PADCEV. Tell your healthcare provider right away if you have dry eyes or blurred vision.

• Skin reactions. Rashes and severe skin reactions can happen while receiving PADCEV. Tell your healthcare provider right away if you get a rash or a skin reaction that continues to get worse.

• Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation). If PADCEV leaks from the injection site or the vein into the nearby skin and tissues, it could cause an infusion site reaction. These reactions can happen right after you receive an infusion, but sometimes may happen days after your infusion. Tell your healthcare provider or get medical help right away if you notice any redness, swelling, itching, or discomfort at the infusion site.

These are not all the possible side effects of PADCEV.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.