PADCEV® Boxed Warning

(enfortumab vedotin)

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 Grade 3 skin reactions [see Dosage and Administration (2.2), Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

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Boxed Warning

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 Grade 3 skin reactions [see Dosage and Administration (2.2), Warnings and Precautions (5.1) and Adverse Reactions (6.1)].
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