(en-for-too-mab - vee-doe-tin)
Trade Name: Padcev®
Enfortumab-vedotin is the generic name for the trade name drug Padcev®. In some cases, health care professional may use the trade name Padcev® when referring to the generic drug name enfortumab-vedotin.
Drug Type: Enfortumab-vedotin is an anti-cancer chemotherapy drug. This medication is classified as a monoclonal antibody, antineoplastic agent, anti-Nectin-4, and antibody conjugate (for more detail see, "How enfortumab-vedotin Works" below).
What Enfortumab-Vedotin Is Used For
- Treatment of adults with locally advanced or metastatic urothelial cancer who have previously received programmed death receptor-1 (PD-1) OR programmed death ligand-1 (PD-L1) inhibitor AND platinum-containing chemotherapy.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How Enfortumab-Vedotin Is Given
- As a short infusion through the vein (intravenous, IV)
- The amount of enfortumab-vedotin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.
Important things to remember about the side effects of enfortumab-vedotin:
- Most people will not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset, duration, and severity.
- Side effects will improve after therapy is complete.
- Side effects may be quite manageable. There are many options to minimize or prevent the side effects.
The following side effects are common (occurring in greater than 30%) for patients taking enfortumab-vedotin:
These are less common side effects (occurring in 10-29%) for patients receiving enfortumab-vedotin:
Not all side effects are listed above. Side effects that are very rare - occurring in less than about 10 percent of patients - are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.
When to Contact Your Doctor or Health Care Provider
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
- Signs of hyperglycemia (high blood sugar)
The following symptoms require medical attention but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24-hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Unusual bleeding or bruising
- Black or tarry stools or blood in your stools
- Blood in your urine
- Extreme fatigue (unable to carry on self-care activities)
- Mouth sores (painful redness, swelling or ulcers)
- Skin reactions, itching (especially if pustules or blisters present)
- Peripheral neuropathy - this is a serious side effect of decreased sensation and paresthesia tinging of fingers and toes may be noted and may last for at least as long as therapy is continued.
- Blurry vision, dry eyes (eye problems)
Always inform your health care provider if you experience any unusual symptoms.
- Before starting enfortumab-vedotin treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
- Do not receive any kind of immunization or vaccination without your doctor's approval while taking enfortumab-vedotin.
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Enfortumab-vedotin may cause fetal harm when given to a pregnant woman. This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking enfortumab-vedotin, the medication must be stopped immediately and the woman given appropriate counseling.
- For both men and women: use contraceptives, and do no conceive a child (get pregnant) while taking enfortumab-vedotin. Barrier methods of contraception, such as condoms, are recommended for up to 2 months for females and 4 months for males after last dose of enfortumab-vedotin.
- Do not breast feed while taking enfortumab-vedotin and for at least 3 weeks after the last enfortumab-vedotin dose.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- You may be at risk of infection, so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
- Wash your hands often.
- To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
- Use an electric razor and a soft toothbrush to minimize bleeding.
- Avoid contact sports or activities that could cause injury.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
- Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
- Eat foods that may help reduce diarrhea.
- Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- Remain active as you are able. Gentle exercise such as a daily walk is encouraged.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing
You will be checked regularly by your doctor while you are taking enfortumab-vedotin, to monitor side effects and check your response to therapy. Periodic blood work will be obtained by your doctor to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver).
How Enfortumab-Vedotin Works
Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.
Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a bit differently, but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.
There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. These targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies.
Enfortumab-vedotin has the component of an antibody type of targeted therapy. Antibodies are an integral part of the body’s immune system. Normally the body creates antibodies in response to an antigen (such as a protein or a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system. To make anti-cancer antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to a patient, these antibodies will attach to matching antigens like a key fits a lock. Since antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually only given for cancers in which antigens and the respective antibodies have been identified already.
Enfortumab-vedotin is an antibody drug conjugate (ADC), meaning that it consists of a targeted therapy monoclonal antibody and an antineoplastic (chemotherapy) agent. These work together to destroy cancer cells.
Enfortumab-vedotin is a monoclonal antibody that targets the Nectin-4 antigen on cancer cell surfaces. When enfortumab-vedotin binds to Nectin-4, the ADC is brought inside the cell and disrupts the microtubule network which is part of the structural network of the cell (skeleton). This disruption stops the cell from dividing and copying itself, which ultimately leads to cell death.
Research continues to identify which cancers may be best treated with targeted therapies.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.