Belantamab Mafodotin-blmf
Class: Antineoplastic Agents
- ADC
- Antibody-drug conjugate
Chemical Name: Immunoglobulin G1, anti-(Tumor necrosis factor receptor superfamily protein TNFRSF17) (humanized monoclonal GSK2857914 γ1-chain), disulfide with humanized monoclonal GSK2857914 κ-chain, dimer
Molecular Formula: C6484H10008N1728O2030S44 . (C49H66N6O11)4
CAS Number: 2050232-20-5
Brands: Blenrep
Warning
Ocular Toxicity
Changes in corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eye, commonly reported.
Perform ophthalmic examinations at baseline, prior to each dose, and promptly for worsening symptoms.
If ocular toxicity occurs, temporary interruption, dosage reduction, or permanent discontinuance of therapy may be necessary. (See Dosage Modification for Toxicity under Dosage and Administration and also see Ocular Effects under Cautions.)
Risk Evaluation and Mitigation Strategy (REMS):
FDA approved a risk evaluation and mitigation strategy (REMS) for belantamab mafodotin-blmf to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of belantamab mafodotin-blmf and consists of the following: a communication plan, elements to assure safe use, and an implementation system. See https://www.accessdata.fda.gov/scripts/cder/rems/.
Introduction
Antineoplastic agent; anti-B-cell maturation antigen (BCMA) antibody conjugated with the microtubule inhibitor monomethyl auristatin F (MMAF).
Uses for Belantamab Mafodotin-blmf
Multiple Myeloma
Treatment of relapsed or refractory multiple myeloma in adults previously treated with ≥4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent (designated an orphan drug by FDA for use in the treatment of multiple myeloma).
Accelerated approval based on response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory study.
Belantamab Mafodotin-blmf Dosage and Administration
General
Perform ophthalmic examinations prior to initiation of belantamab mafodotin and during therapy. Advise patients to use preservative-free ocular lubricant drops during therapy. Avoid contact lens use during therapy unless directed by an ophthalmologist. (See Ocular Effects under Cautions.)
Administer premedication prior to subsequent infusions if grade 2 or 3 infusion-related reactions occur.
Consult specialized references for procedures for proper handling (e.g., use of gloves and protective clothing) and disposal of antineoplastic agents.
Restricted Distribution Program
Distribution of belantamab mafodotin-blmf is restri.
