Padcev

Generic name: Enfortumab Vedotin
Dosage form: injection for intravenous infusion
Drug class: Miscellaneous antineoplastics

Usage of Padcev

Padcev (Enfortumab vedotin) is an antibody-drug conjugate that is given as an intravenous infusion by a healthcare provider and may be used to treat adults with urothelial cancer, the most common type of bladder cancer that is locally advanced or has spread (metastasized) either:

  • in combination with Pembrolizumab (Keytruda)
  • as a single agent in patients who have previously received an immunotherapy medicine and chemotherapy that contains platinum, OR who are not able to receive chemotherapy that contains the medicine cisplatin and have already received 1 or more prior lines of standard bladder cancer therapy.

    • Padcev is a conjugate medicine that contains two active parts: a human IgG1 kappa directed against Nectin-4 which is a protein located on the surface of cells and highly expressed in bladder cancer and MMAE (monomethyl aUristatin E), which is a microtubule-disrupting agent that has been attached to the antibody via a protease-cleavable linker. After Padcev attaches to the surface of cancer cells expressing Nectin-4, it then enters the cells releasing MMAE. This causes the cells to stop dividing and programmed cell death (apoptosis), affecting the growth of the cancer.

    Padcev was first FDA-approved on December 18, 2019.

    Padcev side effects

    Get emergency medical help if you have signs of an allergic Reaction to Padcev such as hives; difficulty breathing; or 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, fever or flu-like symptoms, swollen glands, or painful sores in your mouth, nose, throat, or genital area.

    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. Call your doctor at once if you have symptoms of high blood sugar, such as:

  • increased thirst, dry mouth, fruity breath odor
  • increased urination
  • blurred vision, confusion, drowsiness or
  • nausea, vomiting, stomach pain, loss of appetite.

    • Padcev may cause severe or life-threatening inflammation of the lungs that can lead to death. The risk is higher when used 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 called peripheral neuropathy are common during treatment with Padcev, especially when used with pembrolizumab, and can sometimes be severe. Tell your healthcare provider right away if you get new or worsening numbness or tingling in your hands or feet or muscle weakness.

    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.

    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.

    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.

    • The most common side effects of Padcev when used alone or in combination with pembrolizumab include:

  • laboratory changes (such as in liver or kidney function, blood cells, electrolytes, uric acid)
  • rash
  • tiredness
  • dry eyes
  • increased sugar (glucose) in the blood
  • itching problems
  • diarrhea or constipation
  • nausea
  • hair loss
  • numbness or tingling in your hands
  • weight loss and a decreased appetite
  • peripheral edema
  • changes in taste
  • nerve problems
  • urinary tract infections.

    • Padcev may cause fertility problems in females and males, which may affect the ability to have 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 the FDA at 1-800-FDA-1088.

    Before taking Padcev

    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
  •  are breastfeeding or plan to breastfeed.

    • Pregnancy

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

    If you are a female who can become pregnant your healthcare provider should do a pregnancy test before you start treatment with Padcev and you should use an effective method of birth control during your treatment and for at least 2 months after the last dose. Padcev may affect your chances of having children in the future.

    Males with a female sexual partner who can become pregnant should use an effective method of birth control during treatment and for at least 4 months after the last dose of Padcev. It may be harder for you to get a woman pregnant while you are using this medicine but you should still use birth control to prevent pregnancy because the medicine can harm an unborn baby. If your female partner is already pregnant, Padcev can harm the unborn baby, and sexual intercourse is not recommended. Tell your doctor right away if a pregnancy occurs.

    Breastfeeding

    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.

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    How to use Padcev

    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 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 (Keytruda), 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.

    • Warnings

    Padcev can cause a severe or life-threatening skin rash including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Get emergency medical help if you have a worsening rash with itching, blistering, peeling, skin lesions that look like rings, fever or flu-like symptoms, swollen glands, or painful sores in your mouth, nose, throat, or genital area.

    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 should be withheld if blood glucose rises above is >250 mg/dL.

    Severe and life-threatening fatal pneumonitis/interstitial lung disease (ILD) and peripheral neuropathy have been reported with Padcev. Your healthcare provider will monitor you for these.

    Padcev can also cause dry eyes, vision changes, and other eye disorders. Your doctor will monitor you for these with periodic eye examinations and may tell you to use artificial-tear eye drops to help prevent dry eyes and other eye drops.

    Infusion site reactions may also occur.

    Padcev can cause fetal harm. Women of childbearing age and men with partners who could become pregnant should use effective contraception.

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

    What other drugs will affect Padcev

    Many drugs can interact with Padcev, which may increase the risk of side effects. Tell your doctor about all your other medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.

    Use of Padcev together with dual P-gp and strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir, or clarithromycin) may increase the exposure to MMAE.

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