Padcev® (enfortumab vedotin) is a treatment option for some people with locally advanced or metastatic bladder cancer.1
How does Padcev work?
Enfortumab vedotin targets specific cancer cells by locking onto the Nectin-4 molecule often found in bladder cancers. It is called a Nectin-4-directed antibody and microtubule inhibitor conjugate, which means it combines an antibody with a chemotherapy medication. The antibody portion helps to find and attach to the bladder cancer cells containing the Nectin-4 molecule. Once attached, the chemotherapy portion is released to attack the cancer cell.1
Who can receive Padcev?
Enfortumab vedotin may be used in the treatment of people with locally advanced or metastatic bladder cancer who received prior treatment with either a PD-1 inhibitor or a PD-L1 inhibitor (forms of immunotherapy), and platinum-based chemotherapy. It may also be used to treat people with locally advanced or metastatic bladder cancer who are unable to receive cisplatin chemotherapy and have already received at least one previous treatment.2
Enfortumab vedotin may also be combined with pembrolizumab to treat people with locally advanced or metastatic bladder cancer who are unable to receive cisplatin chemotherapy.2
Locally advanced typically means the cancer has spread beyond the bladder within the bladder region (e.g., to nearby lymph nodes) or has become too large to be removed by surgery. Metastatic means the cancer cells have spread to other parts of the body.
What are the possible side effects of Padcev?
The most common side effects for people taking enfortumab vedotin include:2
- Fatigue
- Peripheral neuropathy (nerve damage that causes tingling or numbness)
- Decreased appetite
- Rash
- Hair loss
- Nausea
- Changes in taste
- Diarrhea
- Itching
- Dry skin
- Lowered white blood cell count (can increase risk of infection), lowered red blood cell count (anemia), lowered platelet count (can increase risk of bleeding/bruising)
- Weight loss
- Changes in certain blood tests
More serious side effects
Enfortumab vedotin can cause some serious side effects. Your healthcare provider will talk with you about the signs and symptoms of the serious side effects that treatment with enfortumab vedotin can cause. These can include:2
- High blood sugar
- Tingling or numbness in the feet and/or hands
- Problems with the eyes, such as vision changes
- Rash or skin reaction
- Lung or breathing problems
- Infusion site reactions
Padcev has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because it can cause serious and possibly life-threatening skin reactions.2
These are not all the possible side effects of enfortumab vedotin. Talk to your doctor about what to expect when taking enfortumab vedotin. You also should call your doctor if you have any changes that concern you when taking enfortumab vedotin.
Things to know about Padcev
Because of its potential for serious side effects, people receiving treatment with enfortumab vedotin should be watched closely. The amount of enfortumab vedotin someone receives may need to be stopped or reduced if people experience certain serious side effects.2
Enfortumab vedotin should not be taken by pregnant people
Enfortumab vedotin can cause harm to a developing fetus and should not be taken by people who are pregnant. While receiving enfortumab vedotin, men with partners who can become pregnant, and people who can become pregnant, should both use contraceptives during treatment and for a period of time after completing treatment. Discuss appropriate birth control methods, and how long you need to use them, with your doctor.2
Women also should not breastfeed during enfortumab vedotin treatment and for a period of time following the final dose. Discuss breastfeeding considerations with your doctor.2
Before beginning treatment for bladder cancer, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information of Padcev.2