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Overview: Padcev is used to treat bladder cancer. It stops cancer cells from growing and helps destroy cancer cells. The most common side effects are rash, tiredness, loss of appetite, numbness or tingling in your hands or feet, hair loss, and dry eyes. Tell your health care provider right away if you have vision changes or itchy eyes, trouble breathing, chest pain, or sudden skin discoloration, pain, or swelling after your infusion. Padcev is given by a health care provider in a hospital or clinic.

Uses

What is Padcev used for?

Padcev (enfortumab vedotin-ejfv) is commonly used for a type of bladder cancer that starts in the lining of the urinary tract (urothelial carcinoma).

Padcev may also be used for other conditions as determined by your health care provider.

How does Padcev work (mechanism of action)?

Padcev works by targeting a protein called Nectin-4, which is found on the surface of certain cancer cells. Padcev is made of two parts: an antibody attached to a medicine. Once the antibody part attaches to the Nectin-4 protein on the cancer cell, Padcev is taken into the cell and releases the medicine part. This disrupts the cell’s structure, causing it to stop growing and to die. Padcev may also attract certain immune system cells to help destroy the cancer cells.

How is Padcev supplied (dosage forms)?

Brands and other names

  • Padcev

Dosage forms and strengths

Padcev is available in an injectable form that is given by a health care provider.

How should I store Padcev?

Padcev is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Padcev?

The most common side effects of Padcev are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • High blood sugar (see below)
  • Changes in liver and kidney tests
  • Blood disorders, such as low white blood cells
  • Rash
  • Tiredness
  • Nerve problems (see below)
  • Low protein levels
  • Hair loss
  • Loss of appetite
  • Electrolyte changes, such as low sodium levels
  • Diarrhea
  • Nausea
  • Itchiness
  • Dry eyes and skin
  • Changes in taste
  • Constipation
  • Weight loss
  • Stomach pain

There may be other side effects of Padcev that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Padcev?

While less common, the most serious side effects of Padcev are described below, along with what to do if they happen.

Severe Allergic Reactions. Padcev may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severe Skin Reactions. Padcev can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms including fever, chills, and muscle aches

High Blood Sugar. Padcev may increase your blood sugar levels, which may lead to or worsen diabetes. Talk to your health care provider about how to maintain healthy blood sugar levels. Keep all appointments with your health care provider to check your blood work. Call your health care provider if you have the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Serious Lung Problems. Padcev can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. These lung problems can be serious or even life-threatening. Get emergency help if you have trouble breathing. Contact your health care provider right away if you have new symptoms of cough or chest pain.

Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people who are using Padcev. Tell your health care provider if you develop the following symptoms in your arms, hands, legs, or feet. 

  • Pain
  • Tingling, prickling, or burning sensation
  • Numbness
  • Weakness 

Eye Problems. Padcev may cause eye problems, such as dry eye, pink eye (conjunctivitis), and inflammation of the cornea (keratitis). Contact your health care provider right away if you have any of the following symptoms.

  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge
  • Vision changes, such as blurry vision or sensitivity to light

Tissue Damage. Padcev is given as an infusion into a vein. If the medicine leaks out of the vein, it could damage the surrounding tissues. Your health care provider will monitor you while you receive your dose. Tell them right away if you have sudden pain, swelling, or skin discoloration during or after your infusion.

Warnings & Precautions

Who should not use Padcev?

Allergies to Ingredients. People who are allergic to any of the following should not use Padcev.

  • Padcev 
  • Enfortumab vedotin
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Padcev.

What should I know about Padcev before using it?

Padcev is usually given by a health care provider in a hospital or clinic.

Padcev may make it difficult for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

Keep all appointments with your health care provider, including appointments for blood tests. Tell your health care provider right away if you have any skin reactions, especially near where the medicine was infused, right after or within a day after you receive Padcev. 

Padcev may cause dry eyes. Your health care provider may suggest that you use artificial tears, which is an eye drop to help prevent dry eyes. 

People who are 65 or older can be at greater risk for side effects from Padcev. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using Padcev?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Padcev is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Padcev may interact with other medicines and supplements. Before using Padcev, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Lung problems
  • Nerve problems, such as tingling or numbness in your hands or feet
  • Diabetes or high blood sugar

Pregnancy. Padcev may cause harm to an unborn baby. If you are able to become pregnant, your health care provider will confirm that you are not pregnant before you start Padcev treatment. Tell your health care provider if you are pregnant or planning to become pregnant. If you can become pregnant, it is recommended to use birth control during Padcev treatment and for two months after your last dose. If your partner can become pregnant, use birth control (such as condoms) during Padcev treatment and for four months after your last dose. 

Breastfeeding. Do not breastfeed while using Padcev and for three weeks after your last dose. It is not known if Padcev passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Padcev?

For more information about Padcev, you can visit the manufacturer’s website at www.padcev.com or call them at 888-472-3238.

Interactions

Does Padcev interact with foods or drinks?

There are no known interactions between Padcev and foods or drinks.

It is unknown if drinking alcohol will affect Padcev, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Padcev interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Padcev.

  • Ketoconazole, which is a medicine used for fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis

Some other medicines may alter the blood levels of Padcev. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Padcev. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Padcev?

If you or someone else has used too much Padcev, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Padcev?

Padcev is given by a health care provider in a hospital or clinic. If you miss an appointment to get your Padcev dose, call to make another appointment as soon as possible.