Black Box Warning

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.