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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 ...