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Brentuximab vedotin

Progressive Multifocal Leukoencephalopathy (PML)

  • JC virus infection resulting in PML and death can occur in patients receiving brentuximab vedotin

Hyperglycemia

  • Serious events of hyperglycemia, such as new-onset hyperglycemia, exacerbation of pre- existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported in ADCETRIS-treated patients. In studies of ADCETRIS monotherapy, 8% of patients experienced any grade hyperglycemia, with 6% experiencing Grade 3 or 4 hyperglycemia. The median time to onset for any grade or Grade 3 or 4 was 1 month (range 0-10). Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

FDA and Industry Communications

Index to FDA Drug Safety Information 

Patient Counseling Information

ADCETRIS

Package Inserts

Brentuximab vedotin

Updated November 2019