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NOW APPROVED

PADCEV® in combination with pembrolizumab (Keytruda®) is now approved as a first treatment for patients with advanced bladder cancer.

Learn more

Setting Our Sights On Living Longer

In a clinical study of 886 adults who had not yet received treatment for advanced bladder cancer, PADCEV with pembrolizumab demonstrated a median overall survival of 32 months vs 16 months with chemotherapy.

How PADCEV may help

Man and woman. Not actual patients. Man and woman. Not actual patients.

PADCEV can be used together with pembrolizumab or by itself to treat advanced* bladder cancer and cancers of the urinary tract (renal pelvis, ureter, or urethra):

PADCEV with pembrolizumab

For people who have not yet received a treatment for advanced bladder cancer

How PADCEV with pembrolizumab may help as a first treatment for advanced bladder cancer

PADCEV alone

For people who have previously received an immunotherapy medicine and chemotherapy that contains platinum (cisplatin or carboplatin)

Or

For people who are unable to receive cisplatin containing chemotherapy and were previously treated with one or more prior therapies

How PADCEV may help after previous treatment for advanced bladder cancer

*Cancer that has spread or cannot be removed by surgery.

Real patient stories

When Bodiul was diagnosed with advanced bladder cancer, he vowed to keep looking for options. After previous rounds of treatment, his new oncologist recommended PADCEV.

Real patient stories

When Bodiul was diagnosed with advanced bladder cancer, he vowed to keep looking for options. After previous rounds of treatment, his new oncologist recommended PADCEV.

View more patient stories

The patients featured in these videos are receiving or have received PADCEV. The patients and their caregivers were compensated by Astellas and Seagen to share their stories. These were their experiences at the time of filming. PADCEV will not work for everyone. Individual results may vary.

View more patient stories

PADCEV Support SolutionsSM can help provide you or your loved one with information about financial assistance programs.

Download the PADCEV Discussion Guide & Symptom Tracker to help start a conversation with your doctor.


Related topics

About Advanced Bladder Cancer

Downloads and Links

Frequently Asked Questions

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

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Important Safety Information


IMPORTANT SAFETY INFORMATION/
WHAT IS PADCEV®?

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

PADCEV may cause serious side effects, including:

Skin reactions. Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, 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

PADCEV Important Safety Information icon.

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 3 weeks after the last dose of PADCEV.

Pregnancy warning for females icon.

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.

Pregnancy warning for male partners icon.

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.

Drug interactions icon.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions icon.

Skin Reactions. See “What is the most important information I should know about PADCEV?”

High blood sugar icon.

High blood sugar (hyperglycemia). An increase in blood sugar is common during treatment with PADCEV. Severe high blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes 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 icon.

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. These severe problems may happen more often when PADCEV is given in combination with pembrolizumab. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon.

Nerve problems. Nerve problems, called peripheral neuropathy, are common during treatment with PADCEV and can sometimes be severe. Nerve problems may happen more often when PADCEV is given in combination with pembrolizumab. 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 icon.

Eye problems. Certain eye problems are common during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, increased tearing, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site (extravasation) icon.

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, blister, peeling skin or discomfort at the infusion site.

Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects.

If your healthcare provider prescribes PADCEV in combination with pembrolizumab for you, also read the Medication Guide that comes with pembrolizumab for important information about pembrolizumab.

• Changes in liver function and kidney function tests

• Rash. See “What is the most important information I should know about PADCEV?”

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Increased lipase (a test done to check your pancreas)

• Decreased white blood cell, red blood cell, and platelet counts

• Tiredness

• Decreased sodium, phosphate, and protein (albumin) in the blood

• Itching

• Diarrhea

• Hair loss

• Decreased weight

• Decreased appetite

• Increased uric acid in the blood

• Increased or decreased potassium

• Dry eye. See “Eye problems”

• Nausea

• Constipation

• Change in sense of taste

• Urinary tract infection

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Changes in liver and kidney function tests

• Decreased white blood cell, red blood cell, and platelet counts

• Rash. See “What is the most important information I should know about PADCEV?”

• Tiredness

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Decreased protein (albumin), sodium, and phosphate in the blood

• Hair loss

• Decreased appetite

• Diarrhea

• Nausea

• Itching

• Increased uric acid in the blood

• Dry eye. See “Eye problems”

• Change in sense of taste

• Constipation

• Increased lipase (a blood test done to check your pancreas)

• Decreased weight

• Stomach (abdominal) pain

• Dry skin

Communicate with your doctor icon.

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 with pembrolizumab (also known as Keytruda®), or

• PADCEV may be used alone if you:

–have received an immunotherapy medicine and chemotherapy that contains platinum, or

–are not able to receive a chemotherapy that contains the medicine cisplatin and you have received 1 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.


Important Safety Information


IMPORTANT SAFETY INFORMATION/
WHAT IS PADCEV®?

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

PADCEV may cause serious side effects, including:

Skin reactions. Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, 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

PADCEV Important Safety Information icon.

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 3 weeks after the last dose of PADCEV.

Pregnancy warning for females icon.

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.

Pregnancy warning for male partners icon.

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.

Drug interactions icon.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions icon.

Skin Reactions. See “What is the most important information I should know about PADCEV?”

High blood sugar icon.

High blood sugar (hyperglycemia). An increase in blood sugar is common during treatment with PADCEV. Severe high blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes 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 icon.

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. These severe problems may happen more often when PADCEV is given in combination with pembrolizumab. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon.

Nerve problems. Nerve problems, called peripheral neuropathy, are common during treatment with PADCEV and can sometimes be severe. Nerve problems may happen more often when PADCEV is given in combination with pembrolizumab. 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 icon.

Eye problems. Certain eye problems are common during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, increased tearing, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site (extravasation) icon.

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, blister, peeling skin or discomfort at the infusion site.

Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects.

If your healthcare provider prescribes PADCEV in combination with pembrolizumab for you, also read the Medication Guide that comes with pembrolizumab for important information about pembrolizumab.

• Changes in liver function and kidney function tests

• Rash. See “What is the most important information I should know about PADCEV?”

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Increased lipase (a test done to check your pancreas)

• Decreased white blood cell, red blood cell, and platelet counts

• Tiredness

• Decreased sodium, phosphate, and protein (albumin) in the blood

• Itching

• Diarrhea

• Hair loss

• Decreased weight

• Decreased appetite

• Increased uric acid in the blood

• Increased or decreased potassium

• Dry eye. See “Eye problems”

• Nausea

• Constipation

• Change in sense of taste

• Urinary tract infection

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Changes in liver and kidney function tests

• Decreased white blood cell, red blood cell, and platelet counts

• Rash. See “What is the most important information I should know about PADCEV?”

• Tiredness

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Decreased protein (albumin), sodium, and phosphate in the blood

• Hair loss

• Decreased appetite

• Diarrhea

• Nausea

• Itching

• Increased uric acid in the blood

• Dry eye. See “Eye problems”

• Change in sense of taste

• Constipation

• Increased lipase (a blood test done to check your pancreas)

• Decreased weight

• Stomach (abdominal) pain

• Dry skin

Communicate with your doctor icon.

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 with pembrolizumab (also known as Keytruda®), or

• PADCEV may be used alone if you:

–have received an immunotherapy medicine and chemotherapy that contains platinum, or

–are not able to receive a chemotherapy that contains the medicine cisplatin and you have received 1 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.


Important Safety Information


IMPORTANT SAFETY INFORMATION/
WHAT IS PADCEV®?

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

PADCEV may cause serious side effects, including:

Skin reactions. Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, 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

PADCEV Important Safety Information icon.

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 3 weeks after the last dose of PADCEV.

Pregnancy warning for females icon.

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.

Pregnancy warning for male partners icon.

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.

Drug interactions icon.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

Skin reactions icon.

Skin Reactions. See “What is the most important information I should know about PADCEV?”

High blood sugar icon.

High blood sugar (hyperglycemia). An increase in blood sugar is common during treatment with PADCEV. Severe high blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes 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 icon.

Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. These severe problems may happen more often when PADCEV is given in combination with pembrolizumab. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, or cough.

Hand with peripheral neuropathy icon.

Nerve problems. Nerve problems, called peripheral neuropathy, are common during treatment with PADCEV and can sometimes be severe. Nerve problems may happen more often when PADCEV is given in combination with pembrolizumab. 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 icon.

Eye problems. Certain eye problems are common during treatment with PADCEV. Tell your healthcare provider right away if you have dry eyes, increased tearing, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.

Infusion site (extravasation) icon.

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, blister, peeling skin or discomfort at the infusion site.

Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects.

If your healthcare provider prescribes PADCEV in combination with pembrolizumab for you, also read the Medication Guide that comes with pembrolizumab for important information about pembrolizumab.

• Changes in liver function and kidney function tests

• Rash. See “What is the most important information I should know about PADCEV?”

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Increased lipase (a test done to check your pancreas)

• Decreased white blood cell, red blood cell, and platelet counts

• Tiredness

• Decreased sodium, phosphate, and protein (albumin) in the blood

• Itching

• Diarrhea

• Hair loss

• Decreased weight

• Decreased appetite

• Increased uric acid in the blood

• Increased or decreased potassium

• Dry eye. See “Eye problems”

• Nausea

• Constipation

• Change in sense of taste

• Urinary tract infection

• Increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)”

• Changes in liver and kidney function tests

• Decreased white blood cell, red blood cell, and platelet counts

• Rash. See “What is the most important information I should know about PADCEV?”

• Tiredness

• Numbness or tingling in your hands or feet. See “Nerve problems”

• Decreased protein (albumin), sodium, and phosphate in the blood

• Hair loss

• Decreased appetite

• Diarrhea

• Nausea

• Itching

• Increased uric acid in the blood

• Dry eye. See “Eye problems”

• Change in sense of taste

• Constipation

• Increased lipase (a blood test done to check your pancreas)

• Decreased weight

• Stomach (abdominal) pain

• Dry skin

Communicate with your doctor icon.

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 with pembrolizumab (also known as Keytruda®), or

• PADCEV may be used alone if you:

–have received an immunotherapy medicine and chemotherapy that contains platinum, or

–are not able to receive a chemotherapy that contains the medicine cisplatin and you have received 1 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.


© 2024 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. MAT-US-PAD-2023-00693 01/24
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.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark jointly owned by Agensys, Inc., and Seagen Inc.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
All other marks referenced herein are the property of their respective owners.


© 2024 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. MAT-US-PAD-2023-00693 01/24
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.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark jointly owned by Agensys, Inc., and Seagen Inc.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
All other marks referenced herein are the property of their respective owners.

© 2024 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. MAT-US-PAD-2023-00693 01/24
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.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark jointly owned by Agensys, Inc., and Seagen Inc.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
All other marks referenced herein are the property of their respective owners.


© 2024 Astellas Pharma US, Inc. and Seagen Inc. All rights reserved. MAT-US-PAD-2023-00693 01/24
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.
PADCEV Support SolutionsSM, a component of Astellas Pharma Support SolutionsSM, is a service mark jointly owned by Agensys, Inc., and Seagen Inc.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
All other marks referenced herein are the property of their respective owners.