Enfortumab vedotin-ejfv (Intravenous)

Enfortumab vedotin-ejfv injection is used to treat urothelial cancer (bladder cancer) that has spread or cannot be removed by surgery. It is used by itself in patients who have tried other cancer medicines (for example, immunotherapy medicine, platinum-containing cancer medicine) or in patients who cannot receive a cancer medicine that contains cisplatin and have had one or more prior treatments. It is also used together with pembrolizumab in patients who cannot receive a cancer medicine that contains cisplatin.

This medicine must be given only by your doctor or under their supervision.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for side effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to confirm that you are not pregnant before starting treatment. Use an effective form of birth control to prevent getting pregnant during treatment and for at least 2 months after your last dose. Males taking this medicine, with female partners who can become pregnant, must use effective birth control during and for at least 4 months after the last dose of this medicine. If you think you have become pregnant while using this medicine, tell your doctor immediately.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Contact your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you notice a change in your blood or urine sugar tests or if you have any questions, contact your doctor.

This medicine may cause lung or breathing problems (e.g., pneumonitis, interstitial lung disease). Contact your doctor right away if you have chest pain, chills, cough, fever, a general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Contact your doctor right away if you experience burning, numbness, tingling, or painful sensations, weakness in the arms, hands, legs, or feet, or unsteadiness. These could be symptoms of a condition called peripheral neuropathy.

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

Inform your doctor if you have pain, redness, or swelling at the infusion site after receiving this medicine.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 children. Safety and effectiveness have not been established.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might happen. 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 certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical issues, especially:

• Diabetes or
• Eye problems (e.g., dry eyes, keratitis) or
• Hyperglycemia (high blood sugar) or
• Peripheral neuropathy (nerve problem)—Use with caution. This may make these conditions worse.

• Liver disease, moderate or severe—Use with caution. The effects may be increased because the medicine may be removed from the body more slowly.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

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

More common

• Blurred vision
• burning, dry, or itching eyes
• burning, numbness, tingling, or painful sensations
• discharge, excessive tearing
• dry eyes
• dry mouth
• eye redness, irritation, or pain
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• lack or loss of strength
• nausea
• rash with flat lesions or small raised lesions on the skin
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• stomach pain
• sweating
• trouble breathing
• unexplained weight loss
• unsteadiness or awkwardness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet

Less common

• Chest pain
• chills
• cough
• fever
• general feeling of discomfort or illness
• thickening of bronchial secretions

Incidence not known

• Blistering, peeling, or loosening of the skin
• diarrhea
• itching
• joint or muscle pain
• red irritated eyes
• red skin lesions, often with a purple center
• redness, tenderness, itching, burning, or peeling of the skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

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. Your health care professional may also know ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Change in taste
• cracks in the skin
• decreased appetite
• dry skin
• hair loss or thinning of the hair
• loss of heat from the body
• loss of taste
• nausea
• painful blisters on the trunk of the body
• 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 the 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.

In the U.S.

• Padcev

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Enfortumab Vedotin

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, 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 this medicine 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.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine 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.