PADCEV
Generic Name/API: enfortumab vedotin-ejfv
Manufacturer: Astellas Pharma
Dosage Forms & Strength & Pack Size:
For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a white to off-white lyophilized powder in a single-dose vial for reconstitution.
Storage:
Store PADCEV vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton. Do not freeze. Do not shake.
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.
IMPORTANT SAFETY 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.
•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:
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.
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)”
•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
The most common side effects of PADCEV when used alone include:
•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
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 the possible side effects of PADCEV.
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
