(enfortumab vedotin-ejfv)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PADCEV safely and effectively. See full prescribing information for PADCEV.

PADCEV® (enfortumab vedotin-ejfv) for injection, for intravenous use
Initial U.S. Approval: 2019

WARNING: SERIOUS SKIN REACTIONS

See full prescribing information for complete boxed warning.

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PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
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Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
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Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. (2.2), (5.1), (6.1)

RECENT MAJOR CHANGES

Indications and Usage (1)                                                                       07/2026

Dosage and Administration (2.1)                                                            07/2026

Warnings and Precautions (5.1), (5.3), (5.4)                                           07/2026

INDICATIONS AND USAGE

PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated:

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in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). (1)
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in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). (1)
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as a single agent for the treatment of adult patients with la/mUC who:
○
have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
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are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. (1)

DOSAGE AND ADMINISTRATION

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For intravenous infusion only. Do not administer PADCEV as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products. (2.3)
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MIBC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes. For patients who:
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are eligible for cisplatin-containing chemotherapy, PADCEV is administered as neoadjuvant treatment on Days 1 and 8 of each 21‑day cycle for 4 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21-day cycle for 5 cycles or until disease recurrence or unacceptable toxicity, or
○
are ineligible for cisplatin-containing chemotherapy, PADCEV is administered as neoadjuvant treatment on Days 1 and 8 of each 21‑day cycle for 3 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21‑day cycle for 6 cycles or until disease recurrence or unacceptable toxicity. (2.1)
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La/mUC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. (2.1)
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La/mUC: The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28‑day cycle until disease progression or unacceptable toxicity. (2.1)
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Avoid use in patients with moderate or severe hepatic impairment. (8.6)

DOSAGE FORMS AND STRENGTHS

For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a lyophilized powder in a single-dose vial for reconstitution. (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

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Hyperglycemia: Diabetic ketoacidosis may occur in patients with and without preexisting diabetes mellitus, which may be fatal. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. Withhold PADCEV if blood glucose is >250 mg/dL. (2.2, 5.2)
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Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD may occur. Withhold PADCEV for Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV for Grade 3 or 4 pneumonitis/ILD. (2.2, 5.3)
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Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy and consider dose interruption, dose reduction, or discontinuation of PADCEV. (2.2, 5.4)
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Ocular Disorders: Ocular disorders, including vision changes, may occur. Monitor patients for signs or symptoms of ocular disorders. Consider prophylactic artificial tears for dry eyes and treatment with ophthalmic topical steroids after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV when symptomatic ocular disorders occur. (5.5)
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Infusion Site Extravasation: Ensure adequate venous access prior to administration. Monitor the infusion site during PADCEV administration and stop the infusion immediately for suspected extravasation. (5.6)
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Embryo-Fetal Toxicity: PADCEV can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. (5.7, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse reactions, including laboratory abnormalities, (≥20%) were:

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PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, rash, increased creatinine, decreased lymphocytes, fatigue, pruritus, decreased sodium, peripheral neuropathy, increased potassium, diarrhea, alopecia, dysgeusia, decreased appetite, nausea, constipation, urinary tract infection, dry eye, increased glucose, decreased weight, decreased potassium, hyperglycemia, decreased phosphate, and decreased neutrophils. (6.1)
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PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC: increased aspartate aminotransferase, increased creatinine, rash, increased glucose, peripheral neuropathy, increased lipase, decreased lymphocytes, increased alanine aminotransferase, decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection, and decreased platelets. (6.1)
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PADCEV as a single agent: increased glucose, increased aspartate aminotransferase, decreased lymphocytes, increased creatinine, rash, fatigue, peripheral neuropathy, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased alanine aminotransferase, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, and dry skin. (6.1)

 

To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Concomitant use of dual P-gp and strong CYP3A4 inhibitors with PADCEV may increase the exposure to monomethyl auristatin E (MMAE). (7.1)

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2026

Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION

PADCEV® (PAD-sev)

(enfortumab vedotin-ejfv)

for injection

If your healthcare provider prescribes PADCEV in combination with the medicines pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, also read the Medication Guide that comes with these medicines for additional important information.

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:

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

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

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).

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PADCEV may be used with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph before and after the surgical removal of your bladder when your bladder cancer has spread into the muscle layer of the bladder (muscle invasive bladder cancer [MIBC]) but not to other parts of the body.
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PADCEV may be used with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph when your bladder or urinary tract cancer has spread or cannot be removed by surgery (locally advanced or metastatic).
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PADCEV may be used alone when your bladder or urinary tract cancer has spread or cannot be removed by surgery (locally advanced or metastatic) if you:
o
have received PD-1 or PD-L1 immunotherapy medicine and chemotherapy that contains platinum, or
o
are not able to receive a chemotherapy that contains cisplatin and you have received 1 or more prior therapies.

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

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

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are currently experiencing numbness or tingling in your hands or feet
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have a history of high blood sugar or diabetes
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have liver problems
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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.
 
Females who are able to become pregnant:
 
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Your healthcare provider should do a pregnancy test before you start treatment with PADCEV.
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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:
 
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If your female partner is pregnant, PADCEV can harm the unborn baby.
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You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV.
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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.

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?

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PADCEV will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
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PADCEV is given over periods of time called “cycles”.
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If you receive PADCEV with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph:
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Each cycle is 21 days.
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You will receive PADCEV on days 1 and 8 of every cycle.
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If you receive PADCEV alone:
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Each PADCEV cycle is 28 days.
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You will receive PADCEV on days 1, 8, and 15 of every cycle.
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Your healthcare provider will decide how many treatment cycles you need.
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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:

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See “What is the most important information I should know about PADCEV?”
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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 get any symptoms of high blood sugar, including:
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frequent urination
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increased thirst
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blurred vision
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confusion
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it becomes harder to control your blood sugar
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drowsiness
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loss of appetite
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fruity smell on your breath
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nausea, vomiting, or stomach pain
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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.
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Nerve problems. Nerve problems called peripheral neuropathy are common during treatment with PADCEV and can also 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.
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Eye problems. Certain eye problems are common during treatment with PADCEV. Tell your healthcare provider right away if you get dry eyes, increased tearing, blurred vision, or any vision changes. You may use artificial tear substitutes to help prevent or treat dry eyes.
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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 get severe side effects.

The most common side effects of PADCEV when used in combination with pembrolizumab include:

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changes in liver function and kidney function tests
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rash. See “What is the most important information I should know about PADCEV?”
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increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)” above.
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numbness or tingling in your hands or feet. See “Nerve problems” above.
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increased lipase (a test done to check your pancreas)
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decreased white blood cell, red blood cell, and platelet counts
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tiredness
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decreased sodium, phosphate, and protein (albumin) in the blood
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itching
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diarrhea
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hair loss
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decreased weight
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decreased appetite
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increased uric acid in the blood
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increased or decreased potassium
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dry eye. See “Eye problems” above.
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nausea
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constipation
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change in sense of taste
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urinary tract infection

The most common side effects of PADCEV when used alone include:

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increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)” above.
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changes in liver and kidney function tests
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decreased white blood cell, red blood cell, and platelet counts
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rash. See “What is the most important information I should know about PADCEV?”
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tiredness
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numbness or tingling in your hands or feet. See “Nerve problems” above.
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decreased protein (albumin), sodium, and phosphate in the blood
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hair loss
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decreased appetite
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diarrhea
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nausea
•
itching
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increased uric acid in the blood
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dry eye. See “Eye problems” above.
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change in sense of taste
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constipation
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increased lipase (a blood test done to check your pancreas)
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decreased weight
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stomach (abdominal) pain
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dry skin

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

These are not all of the possible side effects of PADCEV.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of PADCEV.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about PADCEV that is written for healthcare professionals.

What are the ingredients in PADCEV?

Active ingredient: enfortumab vedotin-ejfv

Inactive ingredients: histidine, histidine hydrochloride monohydrate, polysorbate 20, and trehalose dihydrate.

Manufactured and Marketed by: Astellas Pharma US, Inc., Northbrook, Illinois 60062

Distributed and Marketed by: Seagen Inc., Bothell, WA 98021

U.S. License 2124

PADCEV is a registered trademark jointly owned by Agensys, Inc. and Seagen Inc.

©2026 Agensys, Inc. and Seagen Inc.

For more information, go to www.padcev.com or call 1-888-472-3238

10194-EV-US

 
This Patient Information has been approved by the U.S. Food and Drug Administration.                                                                        Revised: 07/2026

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