Padcev is a prescription medicine used to treat adults with urothelial cancer, the most common type of bladder cancer. 

Padcev (enfortumab vedotin) is a type of medicine known as an antibody-drug conjugate (ADC). It targets Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.

Enfortumab vedotin works to treat bladder cancer by affecting the growth and cell division of cancer cells. By attaching to the surface of the Nectin-4 expressing cancer cells, Padcev can then enter the cells to release an anti-tumor agent called monomethyl auristatin E (MMAE) which results in cell cycle arrest (cell can't reproduce) and apoptosis (programmed cell death).

What is Padcev used to treat?

Padcev is 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 used alone if you have received an immunotherapy medicine and chemotherapy that contains platinum, or if you are not able to receive a chemotherapy that contains the medicine cisplatin and you have received 1 or more prior therapy.

It may be used in combination with pembrolizumab (Keytruda) if you are not able to receive a chemotherapy that contains the medicine cisplatin.

It is not known if this medicine is safe and effective in children.

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 you start treatment, 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.

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 over periods of time called "cycles".

If you receive Padcev alone, each treatment cycle is 28-days. You will receive Padcev on days 1, 8 and 15 of every treatment cycle. Your doctor will determine how many cycles you need.

If you receive Padcev in combination with pembrolizumab, each treatment cycle is 21-days. You will receive Padcev on days 1 and 8 of every 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.

Usual Adult Dose of Padcev for Urothelial Carcinoma:

As a single agent:
1.25 mg/kg (up to a maximum of 125 mg for patients 100 kg or greater) given as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

In combination with pembrolizumab:
1.25 mg/kg (up to a maximum of 125 mg for patients 100 kg or greater) given as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity.

Uses:
- as a single agent for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinumcontaining chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
- in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

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

• numbness or tingling in your hands or feet;

• a history of high blood sugar or diabetes;

• liver disease.

Pregnancy

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 during treatment, 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.

• 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.

Breastfeeding

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

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

In a medical setting an overdose would be treated quickly.

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

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.

Additional side effects when used in combination with pembrolizumab may include:

• urinary tract infection;

• constipation;

• peripheral edema (swelling of the arms, hands, legs and feet);

• dry eye;

• dizziness; or

• arthralgia (joint aches).

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.

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.