PADCEV® Patient Counseling Information

(enfortumab vedotin)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Skin Reactions

Inform patients that severe skin reactions including SJS and TEN with fatal outcomes have occurred after administration of PADCEV, predominantly during the first cycle of treatment but may occur later.

Advise patients to contact their healthcare provider immediately if they develop new target lesions, progressively worsening skin reactions, severe blistering or peeling of the skin [see Boxed Warning and Warnings and Precautions (5.1)].

Hyperglycemia

Inform patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions (5.2)].

Pneumonitis/ILD

Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.3)].

Peripheral Neuropathy

Inform patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions (5.4)].

Ocular disorders

Advise patients to contact their healthcare provider if they experience any visual changes [see Warnings and Precautions (5.5)]. In order to prevent or treat dry eyes, advise patients to use artificial tear substitutes.

Infusion Site Extravasation

Inform patients that infusion site reactions have occurred after administration of PADCEV. These reactions generally occurred immediately after administration but, in some instances, had a delayed onset (e.g., 24 hours). Instruct patients to contact their healthcare provider immediately if they experience an infusion site reaction [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.7) and Use in Specific Population (8.1)].

Females and Males of Reproductive Potential

Advise female patients of reproductive potential to use effective contraception during treatment with PADCEV and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that PADCEV may impair fertility [see Use in Specific Populations (8.3)].

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

Distributed and Marketed by:
Seagen Inc.
Bothell, WA 98021
1-855-4SEAGEN

U.S. License 2124
PADCEV is a registered trademark jointly owned by Agensys, Inc. and Seagen Inc.
©2023 Agensys, Inc. and Seagen Inc.
397124-EV-USA

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Skin Reactions

Inform patients that severe skin reactions including SJS and TEN with fatal outcomes have occurred after administration of PADCEV, predominantly during the first cycle of treatment but may occur later.

Advise patients to contact their healthcare provider immediately if they develop new target lesions, progressively worsening skin reactions, severe blistering or peeling of the skin [see Boxed Warning and Warnings and Precautions (5.1)].

Hyperglycemia

Inform patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions (5.2)].

Pneumonitis/ILD

Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.3)].

Peripheral Neuropathy

Inform patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions (5.4)].

Ocular disorders

Advise patients to contact their healthcare provider if they experience any visual changes [see Warnings and Precautions (5.5)]. In order to prevent or treat dry eyes, advise patients to use artificial tear substitutes.

Infusion Site Extravasation

Inform patients that infusion site reactions have occurred after administration of PADCEV. These reactions generally occurred immediately after administration but, in some instances, had a delayed onset (e.g., 24 hours). Instruct patients to contact their healthcare provider immediately if they experience an infusion site reaction [see Warnings and Precautions (5.6)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.7) and Use in Specific Population (8.1)].

Females and Males of Reproductive Potential

Advise female patients of reproductive potential to use effective contraception during treatment with PADCEV and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that PADCEV may impair fertility [see Use in Specific Populations (8.3)].

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

Distributed and Marketed by:
Seagen Inc.
Bothell, WA 98021
1-855-4SEAGEN

U.S. License 2124
PADCEV is a registered trademark jointly owned by Agensys, Inc. and Seagen Inc.
©2023 Agensys, Inc. and Seagen Inc.
397124-EV-USA

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