Padcev (Enfortumab Vedotin)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
enfortumab vedotin
Drug Class
antibody-drug conjugate
Used For
urothelial cancer (urothelial carcinoma) that has spread or cannot be removed by surgery
How Taken
intravenous infusion over 30 minutes, given weekly

What Is Padcev Used For?

Padcev is a cancer treatment medication that contains the active ingredient enfortumab vedotin. It’s specifically designed to treat a type of cancer called urothelial carcinoma.

Primary Uses

Padcev is used in adults to treat urothelial cancer (urothelial carcinoma) when the cancer has spread throughout the body or cannot be removed through surgery. It can be given alone or in combination with pembrolizumab. When used alone, it’s typically given to people who have already received immunotherapy and platinum-containing chemotherapy treatments.

How to Take Padcev

Padcev is given as an intravenous infusion (through a drip into your vein) by your healthcare team. You cannot take this medication at home.

Dosage Instructions

Your doctor will give you Padcev through an infusion into a vein over 30 minutes. If you receive Padcev alone, you’ll get it once a week for 3 weeks in each 28-day treatment cycle (on days 1, 8, and 15). If you receive Padcev with pembrolizumab, you’ll get it once a week for 2 weeks in each 21-day treatment cycle (on days 1 and 8). Your doctor will determine how many treatment cycles you need.

What If You Miss a Dose?

If you miss a scheduled appointment for your Padcev infusion, call your doctor right away to reschedule. It’s very important that you don’t miss doses of this medicine.

Important: Never miss a dose – contact your doctor immediately if you cannot make it to your appointment

Available Tablet Strengths

20mg
20mg Tablet White to off-white, Powder for injection • vial (Aust R 355870)
30mg
30mg Tablet White to off-white, Powder for injection • vial (Aust R 367410)

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • Low red blood cells (anemia)
  • Decreased white blood cell count
  • Nausea, diarrhea, and vomiting
  • Tiredness
  • Abnormal walking (gait disturbance)
  • Weight loss
  • Decreased appetite
  • Change in sense of taste
  • Dry eyes
  • Hair loss
  • Skin color changes or darkening
  • Increased liver enzymes
  • Underactive thyroid (when used with pembrolizumab)

Seek immediate medical attention if you experience:

  • Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • High blood sugar with symptoms like frequent urination, increased thirst, blurred vision, confusion, drowsiness, fruity breath smell
  • Lung problems including cough, shortness of breath, chest pain
  • Nerve damage causing numbness, tingling, muscle weakness, burning or shooting pain in hands or feet
  • Infusion site reactions with redness, swelling, itching, or discomfort

Important Warnings

Padcev can cause serious side effects that may be life-threatening. It’s crucial to understand these risks and monitor for symptoms throughout your treatment.

Who Should Not Take Padcev

Do not use Padcev if you are allergic to enfortumab vedotin or any of the ingredients listed in the medication. Padcev should not be given to children and adolescents under 18 years of age.

Medical Conditions to Discuss

Tell your doctor if you have high blood sugar or diabetes, or if you’re currently experiencing numbness or tingling in your hands or feet. Also inform your doctor about any other medical conditions you have.

Pregnancy and Breastfeeding

Padcev may harm your unborn baby and should not be used during pregnancy. Women who can become pregnant should use effective contraception during treatment and for at least 7 months after stopping Padcev. Men whose partners can become pregnant should use effective contraception during treatment and for at least 6 months after stopping. Do not breastfeed during treatment with Padcev and for at least 6 months after stopping treatment.

Serious Skin Reactions: Tell your doctor right away if you have signs of severe skin reaction: rash or itching that gets worse or comes back, skin blistering or peeling, painful sores in mouth/nose/throat/genital area, fever or flu-like symptoms, or swollen lymph nodes

Drug Interactions

Some medications can interfere with how Padcev works in your body. Always tell your healthcare team about all medicines you’re taking.

  • Bacterial infection treatments (clarithromycin)
  • Depression medications (nefazodone, escitalopram, fluoxetine, sertraline)
  • Fungal infection treatments (ketoconazole, voriconazole, posaconazole, itraconazole)
  • Hepatitis C treatments (boceprevir, telaprevir)
  • HIV medications (cobicistat, indinavir, nelfinavir, ritonavir, saquinavir)
  • Epilepsy medications (carbamazepine, phenobarbital, phenytoin)
  • Tuberculosis treatments (rifampicin)
  • St. John’s wort (Hypericum perforatum)
  • Goldenseal (Hydrastis canadensis) – do not take with Padcev

Alcohol & Driving

Be cautious with activities that require alertness while taking Padcev, and discuss alcohol consumption with your doctor.

Alcohol

Tell your doctor if you drink alcohol. Your healthcare team needs to know about your alcohol consumption during treatment.

Driving and Operating Machinery

Be careful before you drive or use any machines or tools until you know how Padcev affects you. The medication may cause side effects that could impair your ability to perform these activities safely.

Storage

You will not need to store Padcev yourself. The medication will be stored properly at the pharmacy or hospital ward in a refrigerator at 2°C to 8°C. Any unused portion of the infusion solution will be disposed of safely by your healthcare team and will not be stored for reuse.

Overdose Information

Since Padcev is given under medical supervision, overdose is unlikely. However, if you experience any concerning side effects after receiving Padcev, tell your doctor immediately. In case of emergency, phone the Poisons Information Centre at 13 11 26, contact your doctor, or go to the nearest hospital Emergency Department, even if there are no obvious signs of problems.

Frequently Asked Questions

Treatment duration varies by individual. If receiving Padcev alone, each cycle is 28 days with infusions on days 1, 8, and 15. If receiving Padcev with pembrolizumab, each cycle is 21 days with infusions on days 1 and 8. Your doctor will decide how many treatment cycles you need.

If you miss a scheduled infusion appointment, call your doctor right away to reschedule. It’s very important that you don’t miss doses of this medicine.

Be careful before you drive or use any machines or tools until you know how Padcev affects you. The medication may cause side effects that could impair your ability to drive safely.

Watch for severe skin reactions (rash, blistering, painful sores), high blood sugar symptoms (frequent urination, increased thirst, blurred vision), lung problems (cough, shortness of breath), and nerve damage (numbness, tingling in hands or feet). Contact your doctor immediately if you experience any of these.

Some medications can interfere with Padcev, including certain antibiotics, antifungals, HIV medications, and antidepressants. Always tell your doctor about all medicines, vitamins, and supplements you’re taking. Do not take goldenseal supplements with Padcev.

No, Padcev may harm your unborn baby and should not be used during pregnancy. Women who can become pregnant must use effective contraception during treatment and for at least 7 months after stopping Padcev.

Remind any doctor, dentist, or pharmacist you visit that you’re receiving Padcev. Tell your healthcare team about any symptoms of skin reactions, high blood sugar, lung problems, nerve damage, or eye problems before each treatment.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.