Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion related reactions may include: • fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. 5.2 Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19 Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Therefore, bamlanivimab is not authorized for use in patients [see Limitations of Authorized Use]: o who are hospitalized due to COVID-19, OR o who require oxygen therapy due to COVID-19, OR o who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. 6 OVERALL SAFETY SUMMARY Over 850 subjects have been exposed to bamlanivimab in clinical trials in both hospitalized and non-hospitalized patients. 6.1 Clinical Trials Experience The safety of bamlanivimab is based on interim data from one Phase 2 trial of 465 ambulatory (non-hospitalized) subjects with COVID-19. BLAZE-1 is a randomized, double-blind, placebo-controlled clinical trial in ambulatory adults with mild to moderate COVID-19 symptoms who had sample collection for the first positive SARS-CoV-2 viral infection determination within 3 days prior to the start of the infusion. Subjects were treated with a single infusion of bamlanivimab at doses of 700 mg (N=101), 2,800 mg (N=107), or 7,000 mg (N=101) or placebo (N=156). Based on data from 309 bamlanivimab-treated subjects followed for at least 28 days after treatment, adverse events occurred in 23% bamlanivimab-treated subjects and 26% of placebo-treated subjects. Serious adverse events occurred in 1 placebo-treated subject (1%) and in no bamlanivimab-treated subjects. The most commonly reported adverse event was nausea. Table 2 shows adverse events reported in at least 1% of patients in any treatment group. Bamlanivimab is not authorized at doses of 2,800 mg or 7,000 mg. 13 Reference ID: 4699500