IMPORTANT SAFETY INFORMATION AND USE

What is the most important information I should know about PADCEV^®?

PADCEV may cause serious side effects, including:
Skin reactions. Severe skin reactions have happened in people treated with PADCEV; in some cases severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle (28 days) of treatment but may happen later. Your healthcare provider will monitor you during treatment and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction:

• target lesions (skin reactions that look like rings)
• rash or itching that continues to get worse
• blistering or peeling of the skin
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

See “What are the possible side effects of PADCEV?” for more information about side effects.

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
• have liver problems
• 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. Taking PADCEV with certain other medicines may cause side effects.

How will I 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.

What are the possible side effects of PADCEV? PADCEV may cause serious side effects, including:

• Skin Reactions. See “Skin Reactions” above for more information.

• High Blood Sugar (hyperglycemia). You can develop high blood
  sugar during treatment with PADCEV. High blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes who were treated 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.

• Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

• Peripheral neuropathy. You may develop nerve problems called peripheral neuropathy during treatment with PADCEV. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet, or muscle weakness.

• Eye problems. You can develop certain eye problems during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

• 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.

The most common side effects of PADCEV include:

If you have certain side effects, your healthcare provider may
decrease your dose or stop your treatment with PADCEV for a
period of time (temporarily) or completely.

PADCEV may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

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.

what is padcev?

PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you:

• have received an immunotherapy medicine and chemotherapy that contains platinum, or
• you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received one or more prior therapy.

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

Please see full Prescribing Information/Patient Information for more information, including risk of Serious Side Effects.

© 2022 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. 081-0610-PM 06/22
PADCEV ^® and the PADCEV device are trademarks jointly owned by Agensys, Inc., and Seagen Inc.
Astellas and the flying star logo are registered trademarks of Astellas Pharma Inc.
Seagen and the Seagen logo are registered trademarks of Seagen Inc.