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Padcev

Generic name: enfortumab vedotinen-FORT-ue-mab-ve-DOE-tin ]
Drug class: Miscellaneous antineoplastics

Medically reviewed by Judith Stewart, BPharm. Last updated on Nov 8, 2021.

What is Padcev?

Padcev is an anticancer medicine that affects the growth and cell division of cancer cells.

Padcev is a prescription medicine used to treat adults with cancer of the bladder or urinary tract (renal pelvis, ureter or urethra).

Padcev is used when the cancer is advanced, has spread to other parts of the body (metastatic), or cannot be removed with surgery.

Padcev may be used if you:

  • have received an immunotherapy medicine and chemotherapy that contains platinum, or
  • you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received one or more prior therapy.

Warnings

Padcev can cause a severe or life-threatening skin rash. Get emergency medical help if you have a worsening rash with itching, blistering, peeling, skin lesions that look like rings, a fever or flu-like symptoms, swollen glands, or painful sores in your mouth, nose, throat, or genital area.

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, or are pregnant or plan to become pregnant. Enfortumab vedotin can harm your unborn baby.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

To make sure Padcev is safe for you, tell your doctor if you have ever had:

Enfortumab vedotin can harm an unborn baby if the mother or the father is using this medicine.

  • If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using Padcev and for at least 2 months after your last dose.

  • If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose of Padcev.

  • It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

  • Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using Padcev, and for at least 3 weeks after your last dose.

How is Padcev given?

Padcev is injected into a vein by a healthcare provider.

This medicine must be given slowly over 30 minutes.

Tell your medical caregivers if you feel any burning or pain when Padcev is injected.

Padcev is given in a 28-day treatment cycle. You will receive an injection only on certain days of this cycle. Your doctor will determine how many cycles you need.

This medicine can cause a severe or life-threatening skin rash, especially during the first treatment cycle. Call your doctor right away if you have a new skin rash with itching that gets worse.

Padcev can cause high blood sugar (hyperglycemia) even if you have never had it before or if you are not diabetic. Severe hyperglycemia may be life-threatening. Your blood sugar may need to be checked often.

Padcev can also cause dry eyes. Your doctor may tell you to use artificial-tear eye drops to help prevent dry eyes.

Dosing information

Usual Adult Dose of Padcev for Urothelial Carcinoma:

1.25 mg/kg (up to a maximum of 125 mg for patients 100 kg or greater) IV over 30 minutes on Days 1, 8. and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Use: For locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Padcev injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving Padcev?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Padcev side effects

Get emergency medical help if you have signs of an allergic reaction to Padcev: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medicine can cause a severe or life-threatening skin rash. Get emergency medical help if you have a worsening rash with itching, blistering, peeling, skin lesions that look like rings, a fever or flu-like symptoms, swollen glands, or painful sores in your mouth, nose, throat, or genital area.

Call your doctor at once if you have symptoms of high blood sugar:

  • increased thirst, dry mouth, fruity breath odor;

  • increased urination;

  • blurred vision, confusion, drowsiness; or

  • nausea, vomiting, stomach pain, loss of appetite.

Also call your doctor at once if you have:

  • numbness, tingling, or muscle weakness in your hands or feet;

  • new or worsening cough, trouble breathing, or shortness of breath;

  • pain, redness, and peeling skin on your hands or feet;

  • severely dry eyes, vision problems;

  • redness, itching, swelling, or discomfort where the medicine was injected; or

  • low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Padcev side effects may include:

  • high blood sugar;

  • numbness or tingling;

  • muscle weakness;

  • low blood cell counts;

  • feeling tired;

  • nausea, diarrhea;

  • loss of appetite, weight loss;

  • rash, dry skin, itching;

  • changes in your sense of taste;

  • hair loss; or

  • abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Padcev?

Many drugs can interact with your blood levels of enfortumab vedotin, which may increase side effects. Tell your doctor about all your other medicines, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Padcev only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.