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PADCEV
Enfortumab Vedotin‑ejfv
$1250.00
20mg · 1 vial
BrandBranded medicine· By Astellas
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FDA boxed warningSerious skin reactions
PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
Closely monitor patients for skin reactions.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
About PADCEV
Overview
PADCEV (enfortumab vedotin-ejfv) is a prescription cancer medicine that links an antibody to a cancer-killing drug. It is used in adults with pembrolizumab, with or without berahyaluronidase alfa-pmph, for muscle-invasive bladder cancer before and after bladder removal surgery, or for locally advanced or metastatic urothelial cancer. It can also be used alone for locally advanced or metastatic urothelial cancer after treatment with both a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or after at least one prior treatment when cisplatin-containing chemotherapy is not suitable. It works by targeting a protein called Nectin-4 on cells and releasing a drug inside them that disrupts cell division and leads to cell death.
What it treats
• Muscle-invasive bladder cancer in adults, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, before bladder-removal surgery and continued afterward. • Locally advanced or metastatic urothelial cancer in adults, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph. • Locally advanced or metastatic urothelial cancer in adults, used alone after prior treatment with both a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or when cisplatin-containing chemotherapy is unsuitable and at least one previous line of treatment has been received.
Safety information
Side effects
Common side effects include rash, itching, tiredness, numbness or tingling from nerve damage, hair loss, decreased appetite, weight loss, nausea, diarrhea, constipation, dry eyes and changes in taste. Abdominal pain and dry skin are also common when PADCEV is used alone. Urinary tract infections are common when it is used with pembrolizumab. Common blood test changes include high blood sugar, changes in liver enzymes and kidney-related blood tests, low blood cell counts, and changes in blood minerals and proteins. The pattern of side effects varies depending on whether PADCEV is used alone or with pembrolizumab. Contact your doctor promptly about skin reactions; new or worsening numbness or tingling; dry eyes or vision changes; or suspected leakage of the infusion into surrounding tissue. Skin reactions can be serious. Other serious risks include high blood sugar and diabetic ketoacidosis, which can be fatal and can occur with or without existing diabetes. Lung inflammation, including pneumonitis or interstitial lung disease, can be severe, life-threatening or fatal. These conditions require prompt medical attention. Blood sugar monitoring is particularly important for people with diabetes or those at risk of diabetes or high blood sugar. Your doctor may need to interrupt, adjust or stop treatment because of serious side effects.
FDA boxed warning
Serious skin reactions
PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
Closely monitor patients for skin reactions.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Interactions
Tell your doctor about all medicines you take. Medicines that both inhibit P-gp and strongly inhibit CYP3A4 may increase your exposure to monomethyl auristatin E (MMAE) when used with PADCEV.
Using PADCEV
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label PADCEV EJFV (ENFORTUMAB VEDOTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SEAGEN INC.] (DailyMed, retrieved 19 September 2026).
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