#
PADCEV Injection
  • Professionals
  • FDA PI

PADCEV Injection

Generic name:enfortumab vedotin-ejfv
Dosage form: injection, powder, lyophilized, for solution
Drug class:Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.

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 Grade3 skin reactions [see Dosage and Administration (2.2), Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Indications and Usage for PADCEV Injection

PADCEV® is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who:

have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand ...