Frequently Asked Questions about Padcev™ (enfortumab vedotin-ejfv)

Understand the administration, side effects and answers to frequently asked questions about Padcev™

Generic Name: enfortumab vedotin-ejfv

Trade Name: Padcev™

For which conditions is Padcev approved for? PADCEV is indicated for the treatment of adults with locally advanced or metastatic bladder cancer who have previously been treated with the following: PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy.

What is the mechanism of action? PADCEV is a first-in-class antibody-drug conjugate that is directed against a protein on bladder cancer cells called Nectin-4. By combining an antibody that targets Nectin-4 on the surface of bladder cancer cells, chemotherapy can be delivered directly to the targeted cancer cell and destroy its structure.

How is PADCEV typically given (administered)? PADCEV is given by intravenous infusion.

How are patients typically monitored? During treatment with PADCEV, at a minimum your healthcare provider will do blood tests to check your blood counts before you start treatment and during treatment to check for side effects. Patients at risk for diabetes mellitus or hyperglycemia will have their blood glucose levels monitored. Patients are also monitored for vision changes, skin reactions and peripheral neuropathy.

What are the common (occur in 20% or more of patients) side effects of treatment with PADCEV?

  • Fatigue
  • Peripheral neuropathy
  • Decrease in appetite
  • Rash
  • Hair loss
  • Nausea
  • Changes in taste
  • Diarrhea
  • Dry eye
  • Itchy and dry skin

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PADCEV and certain other medicines may affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Are there any special precautions patients should be aware of before starting treatment?

Tell your doctor about all of your medical conditions. If you have a history of moderate or severe hepatic impairment, it is important that you let your doctor know before your start treatment. Tell your doctor if you’re pregnant or plan to become pregnant. PADCEV may harm your unborn baby. Women who are able to become pregnant should use an effective method of birth control during treatment with PADCEV and for at least two months after stopping PADCEV. Talk to your healthcare provider about birth control methods that may be right for you. Men should also use effective birth control while on treatment with PADCEV and for at least 4 months after completing treatment. Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with PADCEV.

When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. If you experience symptoms of high blood sugar, peripheral neuropathy, eye problems or skin reactions let your healthcare provider know right away. Let your healthcare provider know right away if you notice any discomfort at the infusion site.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONNECT SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONNECT DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

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