Padcev

Padcev is used to treat bladder cancer and cancers of the urinary tract. You may develop high blood sugar during treatment. Tell your healthcare provider if you develop symptoms of high blood sugar.

Padcev Overview

Reviewed: November 15, 2020
Updated: 

Padcev is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract that has spread or cannot be removed by surgery.

This medication belongs to a group of drugs called monoclonal antibodies. It is thought to work by attaching to the surface of cancer cells and entering and releasing cell-killing medicine. 

Padcev comes as an injectable medication to be given by intravenous (IV) infusion into your vein over 30 minutes. It is given on days 1, 8 and 15 of every 28-day cycle.

Common side effects include numbness or tingling in your hands or feet, or muscle weakness, fatigue and decreased appetite.

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Padcev Cautionary Labels

precautionsprecautionsprecautionsprecautions

Uses of 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 if you have:

  • received an immunotherapy medicine and
  • also received a chemotherapy-containing platinum medicine.

It is not known if Padcev is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

Enfortumab vedotin-ejfv

For more information on this medication choose from the list of selections below.

Padcev Drug Class

Padcev is part of the drug class:

Side Effects of Padcev

Padcev may cause serious side effects. See “Padcev Precautions” section.

The most common side effects of Padcev include:

  • numbness or tingling in your hands or feet, or muscle weakness
  • fatigue
  • decreased appetite
  • rash
  • hair loss 
  • nausea 
  • diarrhea
  • change in sense of taste  
  • dry eyes
  • dry skin

If you have certain side effects, your healthcare provider may decrease your dose or stop your treatment with Padcev for a period of time (temporarily) or completely.

Padcev may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of Padcev.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Padcev Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

Drugs categorized as strong CYP3A4 inhibitors such as: clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, and tipranavir.

Drugs categorized as strong CYP3A4 inducers such as: carbamazepine, phenobarbital, phenytoin, primidone, and rifampin.

This is not a complete list of Padcev drug interactions. Ask your doctor or pharmacist for more information.

Padcev Precautions

Padcev may cause serious side effects, including:

  • High blood sugar (hyperglycemia). You can develop high blood sugar during treatment 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
  • Peripheral neuropathy. While receiving Padcev you may experience nerve problems called peripheral neuropathy. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness.

  • Eye problems. You can develop certain eye problems while receiving Padcev. Tell your healthcare provider right away if you have dry eyes, or blurred vision.

  • Skin Reactions. Rashes and severe skin reactions can happen while receiving Padcev. Tell your healthcare provider right away if you get a rash or a skin reaction that continues to get worse.

  • 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, or discomfort at the infusion site.

Padcev Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Padcev, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

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
  • 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 at least 3 weeks 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.

Padcev and Pregnancy

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Padcev. Padcev can harm your unborn baby. 

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.

Padcev and Lactation

Tell your healthcare provider right away if you are breastfeeding or plan to breastfeed. It is not known if Padcev passes into your breast milk. Do not breastfeed during treatment and for at least 3 weeks after the last dose of Padcev.

Padcev Usage

  • Padcev will be given to you by intravenous (IV) infusion into your vein over 30 minutes.
  • You will receive your Padcev over periods of time called cycles.
  • Each Padcev cycle is 28 days.
  • You will receive Padcev on days 1, 8 and 15 of every cycle.
  • Your healthcare provider will decide how many treatment cycles you need.
  • Your healthcare provider may do blood tests regularly during treatment with Padcev.

Padcev Dosage

The recommended dose of Padcev is 1.25 mg/kg (up to a maximum dose of 125 mg) 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.

Padcev Overdose

Padcev is administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

Keep all medical and laboratory appointments. For the best possible benefit, it is important to receive each scheduled dose of Padcev as directed. If you miss a dose, contact your doctor right away.

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