A clinical pharmacy specialist details her experience with the REMS program for administration of belantamab mafodotin in patients with multiple myeloma.
In a recent “Product Profile” from the May issue of the journal ONCOLOGY®, Kathryn Maples, PharmD, BCOP, a clinical pharmacy specialist in Multiple Myeloma at the Winship Cancer Institute of Emory Healthcare in Atlanta, Georgia, reviewed key considerations for prescribing belantamab mafodotin (Blen-rep; bela-maf) to patients with multiple myeloma who have received 4 prior therapies.
Of note, administration of the BMCA-targeted agent in this population may lead to grade 3/4 keratopathy, or eye toxicity, for which it is enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program. Maples detailed what clinicians need to know before setting up the REMS program at their institution.
The REMS program has 3 key players. First, the providers have to enroll, and they will take an assessment quiz as part of their enrollment. But then they can assign delegates, so that could be their [physician assistant, nurse practitioner], or it could be their clinical pharmacists. I have been assigned as a delegate for my providers. Those are going to be the people that are assessing what the eye doctor tells us.
The eye doctor fills out a form that grades the patient’s vision changes as well as their keratopathy changes. We input these data into the REMS program [to determine] if the patient can continue therapy. The patient also has to enroll, so we do that initially as part of their patient education.
The third component, which is important for infusion pharmacists and nurses to be aware of, is the infusion center, which also has to be enrolled in the REMS program. They have the final component, called the REMS checklist; once the drug is given, they sign off on the exact milligram dose that was given, and the day that it was given.
The eye doctors are not enrolled, but they’re a key player. Making sure that you have all 3 of those things set up before you get your first patient going is very critical.