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WHAT IS PADCEV® (enfortumab vedotin-ejfv)?

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.

PATIENT SUPPORT SERVICES

PADCEV Support SolutionsSM
is here to help

PADCEV Support SolutionsSM offers support to help patients
access their medication.

Not actual patients.

PADCEV Support SolutionsSM offers support to help patients access their medication.

Call PADCEV Support Solutions at
1-888-402-0627

Monday-Friday, 8:30 AM to 8:00 PM ET

Visit the PADCEV Support Solutions
website
if you have any questions or
need assistance.

We can help evaluate your insurance coverage

PADCEV Support Solutions offers information to help you understand your insurance coverage for PADCEV®. PADCEV Support Solutions will provide your healthcare professional with a summary of your insurance benefits. We can also help determine if your insurer requires a prior authorization (PA). If your insurer denies a PA request, and your healthcare professional determines that an appeal is appropriate, PADCEV Support Solutions can assist with the appeal.

PADCEV Support Solutions offers patient assistance options and financial assistance information

Copay Assistance Program

The PADCEV Copay Assistance Program is for eligible patients who have private commercial health insurance and are not insured by any federal or state healthcare program. Eligible patients pay as little as $5 per dose and are enrolled in the program for 12 months. Under the program, eligible patients may save up to a maximum of $25,000 per calendar year. There are no income requirements.1

Patient Assistance Program

The PADCEV Patient Assistance Program provides PADCEV at no cost to uninsured patients who meet the program eligibility requirements.2

Financial Assistance Information

For patients who need financial assistance to help cover out-of-pocket costs, PADCEV Support Solutions can provide information about other sources of support that may be able to help.

1By enrolling in the PADCEV Copay Assistance Program (“Program”), the patient acknowledges that they currently meet the eligibility criteria and will comply with the following terms and conditions: The Program is for eligible patients with commercial prescription insurance for PADCEV® (enfortumab vedotin-ejfv) and is good for use only with a valid prescription for PADCEV. The Program has an annual maximum copay assistance limit of $25,000 per calendar year. After the annual maximum on copay assistance is reached, patient will be responsible for the remaining out-of-pocket costs for PADCEV. The Program is not valid for patients insured by any state or federal healthcare program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Patients who move from commercial insurance to federal or state prescription health insurance will no longer be eligible, and agree to notify the Program of any such change. This offer is not valid for cash paying patients. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received by the patient through the Program. This offer is not conditioned on any past, present, or future purchase of PADCEV. This offer is not transferrable, has no cash value, and cannot be combined with any other offer, free trial, prescription savings card, or discount. The full value of the Program benefits is intended to pass entirely to the eligible patient. The benefit available under this Program is valid only for the patient’s out-of-pocket medication costs for PADCEV. The benefit is not valid for any other out-of-pocket costs such as medication administration charges or other healthcare provider services. No other individual or entity (including, without limitation, third party payers, pharmacy benefit managers, or the agents of either) is entitled to receive any benefit, discount, or other amount in connection with this Program. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, and Puerto Rico. This Program is void where prohibited by law. No membership fees. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice for any reason (including to ensure that the offer is utilized solely for the patient’s benefit).

2Subject to eligibility. Void where prohibited by law.

Patient Connect

PADCEV Support Solutions, through the Patient Connect Program, offers additional patient and caregiver support to people like you who have been prescribed PADCEV. This program helps connect you and your loved ones to educational resources and support based on your particular needs to help you manage your disease and daily life while on treatment.

When you call PADCEV Support Solutions, a trained representative will speak with you to understand the types of challenges you may be facing and will customize a search of various independent local and national organizations3 that may provide support and resources right for you and your loved ones. Examples may include:

Emotional Support

Social workers, counseling services, or online communities for you

Emotional support for your family members and friends

Logistical Support

Transportation and lodging assistance to get you to/from appointments

Help with other day-to-day tasks

Informational Support

Other education and resources about the patient’s disease and treatment

Advice and recommendations on nutrition and self-care

3Support is provided through third-party organizations that operate independently and are not controlled or endorsed by Astellas or Pfizer. Availability of support and eligibility requirements are determined by these organizations.

Call PADCEV Support Solutions at
1-888-402-0627

Monday-Friday, 8:30 AM to 8:00 PM ET

Visit the PADCEV Support Solutions
website
if you have any questions or
need assistance.

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

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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

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.

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.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

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

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. 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.

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. 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.

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

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.

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


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

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.

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.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

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

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. 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.

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. 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.

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

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.

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


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

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.

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.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

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

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. 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.

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. 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.

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

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.

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