The bispecific antibodies are supposed to be administered as outpatient therapies. So unfortunately the REMS program mandates the patients to be admitted in the hospital for the step-up dosing observation. But once you learn the familiarity with these drugs, it becomes so much easier for each and every one of us to take those specific steps so that you’d be able to administer those bispecific antibodies in a safer way...
The bispecific antibodies are supposed to be administered as outpatient therapies. So unfortunately the REMS program mandates the patients to be admitted in the hospital for the step-up dosing observation. But once you learn the familiarity with these drugs, it becomes so much easier for each and every one of us to take those specific steps so that you’d be able to administer those bispecific antibodies in a safer way. So first thing is the infrastructure: is the institution able to carry on with an infrastructure that is able to meet the demands of the adverse event profiles? For example, if the patient has CRS), which happens in 70% of the patients with these bispecific antibodies, do we have a mechanism where the patient could receive the treatment for the CRS at home, and for refractory cases, do we have the ability to treat those patients in an immediate care center or an emergency room where everybody is completely aware about this adverse event profile? So once we have those infrastructures set up, it needs somebody that takes ownership of how to disseminate that information. It’s a team effort. So are the APPs on the same page? Are the PharmDs on the same page? And if the patient goes to the emergency room, are the emergency room physicians completely aware about how to manage this adverse event profile? And more importantly, having those tocilizumab and dexamethasone available in the pharmacy at all times and making sure that the patient is aware that a fever is something that the patient should not ignore. So patient education becomes a big part. So once all these aspects of care are taken into consideration, it becomes so much easier for implementing these outpatient administrations of these bispecific antibodies. Just from our experience, when we started to do this, we published in the first 50 patients that we have administered these bispecific antibodies, we did have four patients that we had that had to be readmitted, which is approximately 7% of the patients that need admission instead of all the 100 patients, 100% of the patients admitting for CRS management or CRS observation.
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