11.4 Geriatric Use Of the 309 patients receiving bamlanivimab in BLAZE-1, 11% were 65 years of age and older and 3% were 75 years of age and older. Based on population PK analyses, there is no difference in PK in geriatric patients compared to younger patients. 11.5 Renal Impairment Bamlanivimab is not eliminated intact in the urine, thus renal impairment is not expected to affect the exposure of bamlanivimab. 11.6 Hepatic Impairment Based on population PK analysis, patients with mild hepatic impairment had approximately 20% higher clearance than patients with normal hepatic function. This effect is statistically significant, but not clinically meaningful. Bamlanivimab has not been studied in patients with moderate or severe hepatic impairment. 11.7 Other Specific Populations Based on population PK analysis, the PK of bamlanivimab was not affected by sex, race, and disease severity or inflammation. Body weight had no clinically relevant effect on the PK of bamlanivimab in adults with COVID-19 over the body weight range of 41 kg to 173 kg. 12 OVERDOSAGE Doses up to 7,000 mg (10 times the recommended dose) have been administered in clinical trials without dose-limiting toxicity. Treatment of overdose with bamlanivimab should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with bamlanivimab. 13 DESCRIPTION Bamlanivimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 214 amino acids each and 2 identical heavy chain polypeptides composed of 455 amino acids produced by a Chinese Hamster Ovary (CHO) cell line and molecular weight of 146 kDa. Bamlanivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow to slightly brown solution in a single-dose vial for intravenous infusion after dilution. Each mL contains 35 mg of bamlanivimab, and L-histidine (0.4 mg), L-histidine hydrochloride monohydrate (0.6 mg), sodium chloride (2.9 mg), sucrose (60 mg), polysorbate 80 (0.5 mg), and Water for Injection. The bamlanivimab solution has a pH range of 5.5-6.5. 17 Reference ID: 4699500