From the Guidelines
Padcev (enfortumab vedotin) can cause several side effects, with the most common being peripheral neuropathy, occurring in 56.4% of patients, as well as skin reactions, hyperglycemia, and treatment-related adverse events (TRAEs) leading to discontinuation in 35.0% of patients. Common side effects include fatigue, hair loss, nausea, decreased appetite, diarrhea, dry skin, and rash. More serious side effects include severe skin reactions such as Stevens-Johnson syndrome, hyperglycemia (high blood sugar), and pneumonitis (lung inflammation) 1. Patients may also experience eye problems, infusion-related reactions, and changes in kidney or liver function. Blood abnormalities like neutropenia (low white blood cell count) can occur, increasing infection risk.
Key Side Effects
- Peripheral neuropathy (numbness, tingling, or pain in hands and feet) occurred in 56.4% of patients treated with enfortumab vedotin–pembrolizumab 1
- Skin reactions (15.5%), peripheral neuropathy (6.8%) and hyperglycaemia (6.1%) were also reported 1
- Grade 1-2 treatment-related AEs (TRAEs) occurred in 41.1% of patients treated with enfortumab vedotin plus pembrolizumab and 26.1% with platinum-based ChT 1
Management of Side Effects
Patients should immediately report severe skin reactions (blistering or peeling), breathing difficulties, persistent nausea/vomiting, unusual fatigue, or signs of infection to their healthcare provider. Regular monitoring of blood work, blood sugar levels, and kidney/liver function is necessary throughout treatment. The treatment with enfortumab vedotin could continue until progression, which has implications for adverse event (AE) management 1.
From the FDA Drug Label
PADCEV may cause serious side effects, including: • Skin reactions • High blood sugar (hyperglycemia) • Lung problems • Nerve problems • Eye problems • Leakage of PADCEV out of your vein into the tissues around your infusion site (extravasation)
The side effects of Padcev (enfortumab vedotin) include:
- Skin reactions: rash, itching, blistering, or peeling of the skin
- High blood sugar (hyperglycemia): frequent urination, drowsiness, increased thirst, loss of appetite, blurred vision, fruity smell on breath, confusion, nausea, vomiting, or stomach pain
- Lung problems: trouble breathing, shortness of breath, or cough
- Nerve problems: numbness or tingling in hands or feet, muscle weakness
- Eye problems: dry eyes, increased tearing, blurred vision, or any vision changes
- Infusion site extravasation: redness, swelling, itching, blister, peeling skin, or discomfort at the infusion site The most common side effects of PADCEV when used in combination with pembrolizumab include:
- Changes in liver function and kidney function tests
- Rash
- Increased sugar (glucose) in the blood
- Numbness or tingling in hands or feet
- Increased lipase
- Decreased white blood cell, red blood cell, and platelet counts
- Tiredness
- Decreased sodium, phosphate, and protein (albumin) in the blood
- Itching
- Diarrhea
- Hair loss
- Decreased weight
- Decreased appetite
- Increased uric acid in the blood
- Increased or decreased potassium
- Dry eye
- Nausea
- Constipation
- Change in sense of taste
- Urinary tract infection The most common side effects of PADCEV when used alone include:
- Increased sugar (glucose) in the blood
- Changes in liver and kidney function tests
- Decreased white blood cell, red blood cell, and platelet counts
- Rash
- Tiredness
- Numbness or tingling in hands or feet
- Decreased protein (albumin), sodium, and phosphate in the blood
- Hair loss
- Decreased appetite
- Diarrhea
- Nausea
- Itching
- Increased uric acid in the blood
- Dry eye
- Change in sense of taste
- Constipation
- Increased lipase
- Decreased weight
- Stomach (abdominal) pain
- Dry skin 2 2 2
From the Research
Side Effects of Padcev (Enfortumab Vedotin)
The side effects of Padcev (enfortumab vedotin) have been studied in various clinical trials and real-world studies. Some of the common side effects include:
- Skin toxicity, such as rash, maculopapular rash, and dermatitis allergic 3, 4, 5
- Fatigue 3, 4
- Blood sugar elevations, such as hyperglycemia 3, 4
- Peripheral neuropathy, which can be dose-limiting in responding patients 3, 6, 4
- Gastrointestinal disorders, such as diarrhea and nausea 6, 4
- Dysgeusia (taste disturbance) 6
Serious Side Effects
Some serious side effects have also been reported, including:
- Stevens-Johnson syndrome and toxic epidermal necrolysis, which are rare but potentially fatal cutaneous adverse reactions 5, 7
- Decreased neutrophil count, decreased white blood cell count, and anemia 4
Management of Side Effects
The management of side effects associated with enfortumab vedotin is crucial to minimize their impact on patients. This includes: