Pronunciation:

en-FORT-ue-mab ve-DOE-tin - ejfv

Brand Names:

• Padcev

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Serious Skin ReactionsEnfortumab vedotin-ejfv can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.Immediately withhold enfortumab vedotin-ejfv and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.Permanently discontinue enfortumab vedotin-ejfv in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Enfortumab Vedotin

Uses of This Medicine:

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

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

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 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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other 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.

Other interactions—

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 this medicine. 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 This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted 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 make sure you are not pregnant before starting treatment. 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 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 the medicine, tell your doctor right away.

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 (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with 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 the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

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

Check with your doctor right away if you are having 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.

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).

Tell 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.

Side Effects of This Medicine:

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

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. 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

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.