PATIENT INFORMATION PADCEV (PAD-sev) (enfortumab vedotin-ejfv) for injection | |||
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. | |||
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: | |||
|
| ||
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) that has spread or cannot be removed by surgery.
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:
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?
| |||
What are the possible side effects of PADCEV? PADCEV may cause serious side effects, including:
| |||
Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects. The most common side effects of PADCEV when used in combination with pembrolizumab include: | |||
|
|
| |
The most common side effects of PADCEV when used alone include: | |||
|
|
| |
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. ©2023 Agensys, Inc. and Seagen Inc. For more information, go to www.padcev.com or call 1-888-4-PADCEV 397124-EV-USA |
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2023
PATIENT INFORMATION PADCEV (PAD-sev) (enfortumab vedotin-ejfv) for injection | |||
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. | |||
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: | |||
|
| ||
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) that has spread or cannot be removed by surgery.
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:
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?
| |||
What are the possible side effects of PADCEV? PADCEV may cause serious side effects, including:
| |||
Your healthcare provider may decrease your dose of PADCEV, or temporarily or completely stop your treatment with PADCEV if you have severe side effects. The most common side effects of PADCEV when used in combination with pembrolizumab include: | |||
|
|
| |
The most common side effects of PADCEV when used alone include: | |||
|
|
| |
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. ©2023 Agensys, Inc. and Seagen Inc. For more information, go to www.padcev.com or call 1-888-4-PADCEV 397124-EV-USA |
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2023
{{section_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.