JL519. Modified Outpatient Regimen of Daratumumab to Reduce First Infusion Reaction Risk
Christopher Campen, PharmD, BCOP, Elizabeth H. Cull, MD, Brittany Wills, PharmD, Lise Langston, PharmD, Saeeda Chowdhury, MD, Susan Funk, NP, and Suzanne Fanning, DO; Greenville Health System Cancer Institute
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JADPRO Live at APSHO 2017
Marriott Marquis, Houston, Texas • November 2–5, 2017
Background: Daratumumab (dara) is a CD38 targeting monoclonal antibody with significant activity in multiple myeloma. Infusion-related reactions (IRRs) include cough, dyspnea, bronchospasm, and chills. Between 45% and 71% of patients experienced an IRR on study, mainly with the first treatment. The first treatment of daratumumab must be infused over a prolonged time period, which is difficult to accommodate in the outpatient setting. There is significant interest in reducing the risk of IRRs with the first treatment and providing a treatment schema that allows for outpatient administration in an 8-hour infusion schedule.
Methods: Standard IRR prophylaxis recommended by the manufacturer includes acetaminophen, a steroid, and an antihistamine prior to the infusion. In April 2016 our daratumumab protocol was modified to include additional IRR prophylaxis. Medications added to the standard included dexamethasone the night prior to first treatment with montelukast and famotidine the day of treatment. In order to facilitate outpatient administration, the first dose was split into two days (C1D1/D2) at a dose of 8 mg/kg/day (total 16 mg/kg).
Results: Nineteen patients received daratumumab at the institution, with 15 patients receiving the modified outpatient regimen from November 2015 to January 2017. No patients reported respiratory symptoms during C1D1/D2. The IRR frequency during C1D1/2 was 1/15 (7%). This single patient reported gastrointestinal symptoms and chills during the first infusion and was able to safely continue treatment.
Conclusions: Additional prophylaxis for IRRs and a modified split dose regimen may reduce the risk of IRR with dara and provide for safe outpatient administration with an 8-hour clinic schedule. In our experience, IRRs were significantly reduced when compared to the FDA registry trials. Knowledge of improved tolerance to therapy and easier administration may increase use of daratumumab in the community.
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