Padcev (enfortumab vedotin-ejfv)
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Disease Indications
Urothelial Carcinoma
Manufacturer
Astellas Pharma Inc.
Usage
Intravenous
Medicine approved by
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Food and Drug Administration (FDA)
Patients helped
- Over 2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 87 countries
We can help with your prescription
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We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
Package
Single-dose vial
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Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
What is Padcev (enfortumab vedotin-ejfv) for?
Padcev (enfortumab vedotin-ejfv) is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adults with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread (metastasized) to nearby tissues or to other areas of the body or cannot be removed by surgery (unresectable).1
It may be used by patients who have previously received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine.1
It is available in vial form containing 20 mg or 30 mg enfortumab vedotin-ejfv.1
How does Padcev (enfortumab vedotin-ejfv) work?
Enfortumab vedotin-ejfv works differently from chemotherapy or immunotherapy because it is designed to deliver medicine directly to cancer cells.
It is an antibody-drug conjugate (ADC) that is made up of the antibody (a type of protein) IgG1 and a cytotoxic (anticancer) compound. IgG1 can bind to Nectin-4 on the surface of cancer cells. As a result, the cancer cell absorbs the medicine, and the cytotoxin kills the cancer cell, leaving the healthy cells intact.2,3
Where has Padcev (enfortumab vedotin-ejfv) been approved?
Padcev (enfortumab vedotin-ejfv) was approved for the treatment of advanced urothelial cancer by:
- The Food and Drug Administration (FDA), on December 18, 2019.4
It is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.4
Padcev was granted Accelerated Approval, and Priority Review and Breakthrough Therapy designations, in order to facilitate the (faster) development of promising therapies for diseases that not yet have sufficient treatment options.4
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Padcev (enfortumab vedotin-ejfv) taken?
The standard dosage is:1
- 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg)
A dose of Padcev (enfortumab vedotin-ejfv) is given through a needle in the vein (intravenously) over 30 minutes.1
The treatment is given in cycles of 28 days. The patient receives the medicine on day 1, 8 and 15; one week in every treatment cycle is dose free.1
The healthcare provider will decide how many treatment cycles are needed, and may do regular blood tests during treatment.1
Complete information about Padcev (enfortumab vedotin-ejfv) dosage and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Padcev (enfortumab vedotin-ejfv)?
Common adverse reactions
The most common side effects (≥20% of patients) listed in the prescribing information include:1
- Numbness or tingling in hands or feet, or muscle weakness
- Tiredness (fatigue)
- Decreased appetite
- Rash
- Hair loss
- Nausea
- Diarrhea
- Change in sense of taste
- Dry eyes
- Dry skin
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- High Blood Sugar (hyperglycemia)
- Peripheral neuropathy
- Eye problems
- Skin reactions
- Leakage of Padcev (enfortumab vedotin-ejfv) out of the vein into the tissues around the infusion site (extravasation)
Use in a specific population
Padcev (enfortumab vedotin-ejfv) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding. Your healthcare provider should do a pregnancy test before starting treatment. Patients should use birth control during the treatment, and for at least 3 week after the last dose.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1
References
1. Full prescribing information [FDA]: Padcev (enfortumab vedotin-ejfv) [PDF]
Astellas Pharma US Inc., Dec 18, 2019
2. Definition of enfortumab vedotin-ejfv
National Cancer Institute, cited on Nov 20, 2020
3. What is Padcev and how does it work?
Astellas, cited on Nov 20, 2020
4. FDA approves new type of therapy to treat advanced urothelial cancer
FDA press release, December 18, 2019
The Food and Drug Administration (FDA) approval of Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial carcinoma based on the data of Study EV-201 (NCT03219333).1
EV-201 was a single-arm, multicenter trial that involved 125 adults with advanced bladder cancer who had received an immunotherapy medicine and chemotherapy-containing platinum medicine before treatment with enfortumab vedotin-ejfv. Patients received 1.25 mg/kg via intravenous infusion over 30 minutes on day 1, 8, 15 of a 28-day cycle. Treatment continued until disease progression or unacceptable toxicity.2
Results
The main efficacy outcome was overall response rate (ORR), which is defined as the percentage of patients experiencing partial or complete shrinkage of their tumors. Additionally, duration of response (DOR) was measured to evaluate how long that shrinkage lasted.2
Enfortumab vedotin-ejfv treatment resulted in a clinically meaningful response in patients.3
The ORR was 44, with 12% (n=15) of patients having a complete response, and 32% (n=40) of patients having a partial response.3
Responses lasted more than 7 months in more than half of responders.3
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Padcev (enfortumab vedotin-ejfv) for the approved indication.1
References
1. Full prescribing information [FDA]: Padcev (enfortumab vedotin-ejfv) [PDF]
Astellas Pharma US Inc., Dec 18, 2019
2. A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)
Clinical trial EV-201, cited on Nov 20, 2020
3. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors
Petrylak DP, Journal of Clinical Oncology, Jun 5, 2019
Padcev (enfortumab vedotin-ejfv) treatment costs
The cost for a monthly or yearly treatment of Padcev (enfortumab vedotin-ejfv) depends on your prescription requirements which includes the dosage in mg and medicine type (Single-dose vial ).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Padcev (enfortumab vedotin-ejfv) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Padcev (enfortumab vedotin-ejfv) price and additional costs
The price of Padcev (enfortumab vedotin-ejfv)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
Our Named Patient support fee
TheSocialMedwork provides access to Padcev (enfortumab vedotin-ejfv) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
Shipping costs
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Padcev (enfortumab vedotin-ejfv)
When you buy Padcev (enfortumab vedotin-ejfv), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Padcev (enfortumab vedotin-ejfv) reimbursement
It might be possible for you to claim the cost of Padcev (enfortumab vedotin-ejfv) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Four steps to access the medicines you need
How and where to buy Padcev: You can order Padcev from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
