20 ML vilobelimab 10 MG/ML Injection

DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Dosage and Administration (2.2) ] for a maximum of 6 (six) doses over the treatment period as described below. Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). 2.2 Preparation and Administration Preparation Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration. For the recommended dose of 800 mg GOHIBIC, dilute 80 mL of GOHIBIC in 170 mL of 0.9% Sodium Chloride at room temperature. Use a 250 mL infusion bag of 0.9% Sodium Chloride solution USP and the follow steps below: Withdraw 80 mL of 0.9% Sodium Chloride solution USP from the infusion bag and discard. Withdraw the 80 mL of GOHIBIC from the vials and add slowly to the 0.9% Sodium Chloride solution USP infusion bag to a final concentration of 3.2 mg/mL. To mix the solution, gently invert the bag to avoid foaming. Storage of Diluted GOHIBIC Diluted GOHIBIC must be used within 4 hours when stored at room temperature 20°C to 25°C (68°F to 77°F). Diluted GOHIBIC stored under refrigeration at 2°C to 8°C (36°F to 46°F) must be used within 24 hours. After removal of diluted GOHIBIC from the refrigerator stored at 2°C to 8°C (36°F to 46°F), it must be left to acclimatize to room temperature prior to administration. Administration Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present. Administer diluted GOHIBIC via intravenous infusion over 30 - 60 minutes. Avoid concomitant administration of GOHIBIC with other drugs in the same intravenous line.

WARNINGS AND PRECAUTIONS There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use. 5.1 Serious Infections Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6) ] . 5.2 Hypersensitivity Reactions Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.

CONTRAINDICATIONS No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.

Mechanism of Action GOHIBIC is a chimeric monoclonal IgG4-kappa antibody that binds to C5a with a dissociation constant of 9.6pM and blocks its interaction with the C5a receptor. C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.