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Enfortumab vedotin-ejfv (Intravenous)

Commonly used brand name(s)

In the U.S.

  • Padcev

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Enfortumab Vedotin

Uses for enfortumab vedotin-ejfv

Enfortumab vedotin-ejfv injection is used to treat patients with urothelial cancer (bladder cancer) that has spread or grown and have tried other cancer medicines but did not work well.

Enfortumab vedotin-ejfv is to be given only by or under the supervision of your doctor.

Before using enfortumab vedotin-ejfv

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For enfortumab vedotin-ejfv, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to enfortumab vedotin-ejfv or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of enfortumab vedotin-ejfv injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of enfortumab vedotin-ejfv injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of enfortumab vedotin-ejfv. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Eye problems (eg, dry eyes, keratitis) or
  • Hyperglycemia (high blood sugar) or
  • Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.
  • Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of enfortumab vedotin-ejfv

Medicines used to treat cancer are very strong and can have many side effects. Before receiving enfortumab vedotin-ejfv, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you enfortumab vedotin-ejfv in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. The infusion will be given on Days 1, 8, and 15 of a 28-day cycle.

Enfortumab vedotin-ejfv comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Missed dose

Enfortumab vedotin-ejfv needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions while using enfortumab vedotin-ejfv

It is very important that your doctor check your progress at regular visits to make sure that enfortumab vedotin-ejfv is working properly. Blood tests may be needed to check for unwanted effects.

Receiving enfortumab vedotin-ejfv while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 2 months after your last dose. Males who are taking enfortumab vedotin-ejfv, with female partners who can become pregnant, must use effective birth control during and for at least 4 months after the last dose of enfortumab vedotin-ejfv. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using enfortumab vedotin-ejfv. Some men using enfortumab vedotin-ejfv have become infertile (unable to have children).

Enfortumab vedotin-ejfv may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Check with your doctor immediately if blurred vision, difficulty in reading, dry eyes, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Skin reactions can occur with enfortumab vedotin-ejfv. Check with your doctor right away if you have a rash, itching skin, redness, swelling, or pain of the skin, scaling of the skin on hands and feet, skin blisters, or tingling of the hands and feet.

Tell your doctor if you have pain, redness, or swelling at the infusion site after receiving enfortumab vedotin-ejfv.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Enfortumab vedotin-ejfv side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  • Abdominal or stomach pain
  • blurred vision
  • burning, numbness, tingling, or painful sensations
  • dry eyes
  • dry mouth
  • eye redness, irritation, or pain
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • nausea
  • rash with flat lesions or small raised lesions on the skin
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unsteadiness or awkwardness
  • unusual tiredness or weakness
  • vomiting
  • weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Change in taste
  • cracks in the skin
  • decreased appetite
  • diarrhea
  • dry skin
  • hair loss or thinning of the hair
  • itching skin
  • loss of heat from the body
  • loss of taste
  • nausea
  • red, swollen skin redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • skin blisters
  • tingling of the hands and feet
  • ulceration of the skin
  • vomiting

Less common

  • Pain, redness, or swelling at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

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