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.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

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.

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

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.

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.

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.

What are the possible side effects of PADCEV?

PADCEV may cause serious side effects, including:

Skin Reactions. 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 have any symptoms of high blood sugar, including: frequent urination, increased thirst, blurred vision, confusion, it becomes harder to control your blood sugar, drowsiness, loss of appetite, fruity smell on your breath, 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 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 have 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 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.

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

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

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