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Ocular Toxicity

  • BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes [see Warnings and Precautions (5.1)].
  • Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].
  • Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS [see Warnings and Precautions (5.2)].

Approved Risk Evaluation and Mitigation Strategies (REMS)

BLENREP (Belantamab Mafodotin) Injection

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Updated September 2020