Enfortumab Vedotin-ejfv (PADCEV)
Drug Information
Kevin Van, PharmD, BCPS (Editor)
2 min read
Enfortumab Vedotin-ejfv (PADCEV)
Antibody Drug Conjugate | Antineoplastic Agent
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BLACK BOXED WARNING
PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
These reactions occurred predominantly during the first cycle of treatment, but may occur later.
Patients should be closely monitored for skin reactions.
PADCEV should be immediately withheld and referral for specialized care should be considered for suspected SJS or TEN or severe skin reactions.
PADCEV should be permanently discontinued in patients with confirmed SJS or TEN, or Grade 4 or recurrent Grade 3 skin reactions.
PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
These reactions occurred predominantly during the first cycle of treatment, but may occur later.
Patients should be closely monitored for skin reactions.
PADCEV should be immediately withheld and referral for specialized care should be considered for suspected SJS or TEN or severe skin reactions.
PADCEV should be permanently discontinued in patients with confirmed SJS or TEN, or Grade 4 or recurrent Grade 3 skin reactions.
Dosing and Administration
- The recommended dose is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes.
- For monotherapy, administer on days 1, 8, and 15 of a 28-day cycle.
- When used in combination with pembrolizumab, administer on days 1 and 8 of a 21-day cycle.
- Dose reductions may be needed for adverse reactions. The first reduction is to 1 mg/kg, second to 0.75 mg/kg, and third to 0.5 mg/kg.
Patient Monitoring
- Closely monitor patients for skin reactions, especially during the first cycle of treatment.
- Monitor blood glucose levels, as hyperglycemia can occur.
- Watch for signs of peripheral neuropathy, which is common and can be severe.
- Assess for ocular disorders, including dry eye symptoms.
Adverse Reactions Management
- For severe skin reactions, immediately withhold PADCEV and consider referral to a specialist.
- Permanently discontinue for confirmed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
- Consider dose interruption or reduction for symptomatic ocular disorders.
- Withhold treatment for Grade 2 or higher peripheral neuropathy until improvement to Grade ≤1.
Patient Education
- Advise patients to immediately report new or worsening skin reactions, respiratory symptoms, numbness/tingling in hands/feet, or visual changes.
- Instruct patients on the importance of artificial tears for dry eye prevention and treatment.
- Inform patients about the risk of infusion site reactions and the need to report them promptly.
Special Populations
- Verify pregnancy status before initiating treatment in females of reproductive potential.
- No dose adjustment is required for mild to severe renal impairment.
- Avoid use in patients with moderate to severe hepatic impairment.
- https://www.padcev.com/hcp/dosing-calculator
- https://www.padcev.com/hcp/resources
- https://www.padcev.com/hcp/dosing
- https://www.padcev.com/hcp
- https://www.padcev.com/Content/hcp/pdf/PADCEV-Dosing-and-Administration-Guide.pdf
- https://www.pfizer.com/products/product-detail/padcev
- https://www.pfizermedicalinformation.com/padcev
- https://www.padcev.com/about-padcev
- https://reference.medscape.com/drug/padcev-enfortumab-vedotin-4000028