Usual Adult Dose for COVID-19

For investigational use only

800 mg IV for up to 6 doses as follows:

• 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 intensive care unit).

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of vilobelimab for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO); this drug is not approved by the US FDA for this use.
• For additional information: https://www.fda.gov/drugs/emergency-preparedness-drugs/emergency-use-authorizations-drugs-and-non-vaccine-biological-products

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer diluted solution via IV infusion over 30 to 60 minutes.
• Do not coadminister with other drugs in the same IV line.

• Unopened vials: Store refrigerated at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze or shake.
• Diluted solution: Must be used within 4 hours when stored at room temperature (20C to 25C [68F to 77F]); must be used within 24 hours when stored under refrigeration (2C to 8C [36F to 46F]).
• After removal from refrigerated storage, allow to reach room temperature before administration.

• Dilution is required before administration.
• The manufacturer product information should be consulted.

• Compatible: 0.9% Sodium Chloride solution, USP

• The Fact Sheet for Health Care Providers should be consulted for information regarding available alternatives.
• ClinicalTrials.gov should be consulted for information on clinical trials of this and other therapies for the treatment of COVID-19.

• Read the Fact Sheet for Patients and Caregivers.