PADCEV® (enfortumab vedotin-ejfv) 2 DOSAGE AND ADMINISTRATION

(enfortumab vedotin-ejfv)

Prescribing Information

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosages for PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, and PADCEV as a single agent are presented in Table 1 and Table 2.

Administer PADCEV as an intravenous infusion over 30 minutes as recommended [see Instructions for Preparation and Administration (2.3)]. Administer PADCEV prior to pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph if administering on the same day.

Table 1. Recommended Dosages for PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph*
Indication	Recommended PADCEV Dosage	Duration of Therapy
* Administer PADCEV prior to pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph if administering on the same day. For the recommended dosage of pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, refer to the respective Prescribing Information. † Cisplatin ineligibility is defined as meeting at least one of the following criteria: Creatinine clearance of less than 60 mL/min, ECOG PS 2 or higher, Grade 2 or higher hearing loss, NYHA Class III or higher heart failure, or Grade 2 or higher peripheral neuropathy.
Neoadjuvant and Adjuvant Muscle Invasive Bladder Cancer (MIBC)	PADCEV 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle.	Patients who are cisplatin-eligible†: • Neoadjuvant: 4 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity. • Adjuvant: 5 cycles or until disease recurrence or unacceptable toxicity.
		Patients who are cisplatin-ineligible†: • Neoadjuvant: 3 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity. • Adjuvant: 6 cycles or until disease recurrence or unacceptable toxicity.
Locally advanced or metastatic Urothelial Cancer (la/mUC)	PADCEV 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle.	Until disease progression or unacceptable toxicity.

Table 2. Recommended Dosages for PADCEV as a single agent
Indication	Recommended PADCEV Dosage	Duration of Therapy
Locally advanced or metastatic Urothelial Cancer (la/mUC)	PADCEV 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1, 8, and 15 of a 28-day cycle.	Until disease progression or unacceptable toxicity.

2.2 Dose Modifications

Table 3. Dose Modifications
Adverse Reaction	Severity*	Dose Modification*
* Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening.
Skin Reactions [see Boxed Warning, Warnings and Precautions (5.1)]	For persistent or recurrent Grade 2 skin reactions	Consider withholding until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level.
	Grade 3 skin reactions	Withhold until Grade ≤1, then resume treatment at the same dose level or dose reduce by one dose level.
	Suspected SJS or TEN	Immediately withhold, consult a specialist to confirm the diagnosis. If not SJS/TEN, see Grade 2-4 skin reactions.
	Confirmed SJS or TEN; Grade 4 or recurrent Grade 3 skin reactions	Permanently discontinue.
Hyperglycemia [see Warnings and Precautions (5.2)]	Blood glucose >250 mg/dL	Withhold until elevated blood glucose has improved to ≤250 mg/dL, then resume treatment at the same dose level.
Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)]	Grade 2	Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level.
	Grade ≥3	Permanently discontinue.
Peripheral Neuropathy [see Warnings and Precautions (5.4)]	Grade 2	Withhold until Grade ≤1, then resume treatment at the same dose level (if first occurrence). For a recurrence, withhold until Grade ≤1, then resume treatment reduced by one dose level.
Peripheral Neuropathy [see Warnings and Precautions (5.4)]	Grade ≥3	Permanently discontinue.
Other Nonhematologic Toxicity [see Adverse Reactions (6)]	Grade 3	Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level.
Other Nonhematologic Toxicity [see Adverse Reactions (6)]	Grade 4	Permanently discontinue.
Hematologic Toxicity [see Adverse Reactions (6)]	Grade 3, or Grade 2 thrombocytopenia	Withhold until Grade ≤1, then resume treatment at the same dose level or consider dose reduction by one dose level.
Hematologic Toxicity [see Adverse Reactions (6)]	Grade 4	Withhold until Grade ≤1, then reduce dose by one dose level or discontinue treatment.

Table 4. Recommended Dose Reduction Schedule
Dose Reduction Schedule	Dose Level
Starting dose	1.25 mg/kg up to 125 mg
First dose reduction	1 mg/kg up to 100 mg
Second dose reduction	0.75 mg/kg up to 75 mg
Third dose reduction	0.5 mg/kg up to 50 mg

2.3 Instructions for Preparation and Administration

•: Administer PADCEV as an intravenous infusion only.
•: PADCEV is a hazardous drug. Follow applicable special handling and disposal procedures.1

Prior to administration, the PADCEV vial is reconstituted with Sterile Water for Injection (SWFI). The reconstituted solution is subsequently diluted in an intravenous infusion bag containing either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer’s Injection, USP.

Reconstitution in Single-Dose Vial

1.

Follow procedures for proper handling and disposal of anticancer drugs.

2.

Use appropriate aseptic technique for reconstitution and preparation of dosing solutions.

3.

Calculate the recommended dose based on the patient’s weight to determine the number and strength (20 mg or 30 mg) of vials needed.

4.

Reconstitute each vial as follows and, if possible, direct the stream of SWFI along the walls of the vial and not directly onto the lyophilized powder:

a.: 20 mg vial: Add 2.3 mL of SWFI, resulting in 10 mg/mL PADCEV.
b.: 30 mg vial: Add 3.3 mL of SWFI, resulting in 10 mg/mL PADCEV.

5.

Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle for at least 1 minute until the bubbles are gone. DO NOT SHAKE THE VIAL. Do not expose to direct sunlight.

6.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be clear to slightly opalescent, colorless to light yellow, and free of visible particles. Discard any vial with visible particles or discoloration.

7.

Based upon the calculated dose amount, the reconstituted solution from the vial(s) should be added to the infusion bag immediately. This product does not contain a preservative. If not used immediately, reconstituted vials may be stored for up to 24 hours in refrigeration at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Discard unused vials with reconstituted solution beyond the recommended storage time.

Dilution in Infusion Bag

1.: Withdraw the calculated dose amount of reconstituted solution from the vial(s) and transfer into an infusion bag.
2.: Dilute PADCEV with either 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer's Injection. The infusion bag size should allow enough diluent to achieve a final concentration of 0.3 mg/mL to 4 mg/mL PADCEV.
3.: Mix diluted solution by gentle inversion. DO NOT SHAKE THE BAG. Do not expose to direct sunlight.
4.: Visually inspect the infusion bag for any particulate matter or discoloration prior to use. The reconstituted solution should be clear to slightly opalescent, colorless to light yellow, and free of visible particles. DO NOT USE the infusion bag if particulate matter or discoloration is observed.
5.: Discard any unused portion left in the single-dose vials.

Administration

1.: Immediately administer the infusion over 30 minutes through an intravenous line.
2.: If the infusion is not administered immediately, the prepared infusion bag should not be stored longer than 8 hours at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE.

DO NOT administer PADCEV as an intravenous push or bolus.

DO NOT mix PADCEV with, or administer as an infusion with, other medicinal products.

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:
• 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.
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). • 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. • 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). • 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: • 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. Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with PADCEV. o 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: o If your female partner is pregnant, PADCEV can harm the unborn baby. o You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of 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. 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. • PADCEV is given over periods of time called “cycles”. • If you receive PADCEV with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph: o Each cycle is 21 days. o You will receive PADCEV on days 1 and 8 of every cycle. • If you receive PADCEV alone: o Each PADCEV cycle is 28 days. o 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: • 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 get any symptoms of high blood sugar, including:
	o frequent urination o increased thirst o blurred vision o confusion o it becomes harder to control your blood sugar o drowsiness o loss of appetite o fruity smell on your breath o 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 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. • 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. • 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:
• 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)” above. • numbness or tingling in your hands or feet. See “Nerve problems” above.		• 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” above. • nausea • constipation • change in sense of taste • urinary tract infection
The most common side effects of PADCEV when used alone include:
• increased sugar (glucose) in the blood. See “High blood sugar (hyperglycemia)” above. • 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” above. • 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” above. • change in sense of taste • constipation • increased lipase (a blood test done to check your pancreas) • decreased weight • stomach (abdominal) pain • 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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