Padcev
We support you to access approved medicine that is not approved or available in your country of residence. Make an enquiry below to learn more.
Disease Indications
Urothelial Carcinoma
Manufacturer
Astellas Pharma Inc.
Usage
Intravenous
Medicine approved by
-
Food and Drug Administration (FDA)
Patients helped
- Over 1.2 million patients reached
- Over 11,000 patients helped
- 13,000 medicines supplied
- 100% success delivering to people in 85 countries
Safe and Secure
We are registered with the Dutch Ministry of Health in The Hague, as an intermediary, registration number: 6730 BEM and as a wholesale distributor, registration number: 16258 G.
Package
Single-dose vial
Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Manager
Maria Chironi
Patient Support
Our patients share their stories
Read moreWhat 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) given into the vein (intravenous infusion)
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
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.
-
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.
-
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.
-
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.
-
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.
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
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.
Patient reviews
“I want to recommend everyone to work with this organization. They are reliable, honest, punctual and do everything to meet your needs…”
“Dr. Aysen Simsek and her team offered assistance during a very difficult time. I truly appreciate their quick, efficient and professional attitude, as well as their patience and superb customer service…”
“I highly recommend TheSocialMedwork. They welcomed me with open arms when I went to their office in Amsterdam. I was in a very difficult situation with a tight schedule, and their amazing team members…”
We are highly rated by our patients
About us
We are TheSocialMedwork, a registered medical intermediary that helps you access elsewhere approved medicines, no matter where you live. To date, we have assisted patients in over 80 countries to access thousands of life-improving medicines.
Learn moreAbout us
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.
