FDA-AUTHORIZED FOR EMERGENCY USE
The U.S. Food and Drug Administration has issued an EUA for the emergency use of GOHIBIC for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). However, GOHIBIC is not FDA-approved for this use.1
FDA AUTHORIZATION MATERIALS:
GOHIBIC has not been approved but has been authorized for emergency use by the FDA under an EUA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO.1,2
The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.2
What is Covid-19?
COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through contact with another person who has the virus. To learn more about COVID-19, ask your healthcare provider. You may also visit https://www.cdc.gov/COVID19 or contact your local or state public health department.3
WHAT IS GOHIBIC (vilobelimab)?3
GOHIBIC is an investigational medicine used for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). GOHIBIC is investigational because it is still being studied. GOHIBIC is not FDA-approved for any indication, including for the treatment of COVID-19.
There is limited information known about the safety or effectiveness of using GOHIBIC to treat people in the hospital with COVID-19. Available results from clinical trials in adults indicate that treatment with GOHIBIC may decrease the risk of dying in hospitalized adults with COVID-19 when initiated within 48 hours of receiving IMV or ECMO. The safety and effectiveness of GOHIBIC have not been studied in children hospitalized with COVID-19.
AUTHORIZED USE FOR GOHIBIC
The U.S. Food and Drug Administration has issued an EUA for the emergency use of GOHIBIC (vilobelimab) for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). However, GOHIBIC is not FDA approved for this use.1
IMPORTANT SAFETY INFORMATION
Before starting GOHIBIC, tell your healthcare provider if you:
Have an infection other than COVID-19
Are pregnant or plan to become pregnant
Are breast-feeding or plan to breastfeed
Have any serious illnesses
Are taking any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements
Do not take GOHIBIC if you are allergic to any of its ingredients.
GOHIBIC may cause serious side effects, including:
Serious Infections: GOHIBIC is a medicine that affects your immune system. GOHIBIC can lower the ability of your immune system to fight infections other than COVID-19.
Allergic Reactions: Serious allergic reactions can happen during or after treatment with GOHIBIC. These reactions may be severe or life-threatening.
Signs and symptoms of a serious allergic reaction with GOHIBIC may include:
Swelling of your face, eyes, lips, mouth, tongue, and throat
The most common side effects of GOHIBIC include:
Lung infection, sepsis, sudden confusion, sudden lung artery blockage, high blood pressure, collapsed lung, venous blood clotting (usually in the leg), herpes infection, certain infections caused by enterococci, urinary tract infection, low blood oxygenation, low platelets, the presence of air in the space in the chest between the two lungs, infection of the respiratory tract, heart arrythmia, constipation, and rash.
Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to InflaRx by calling 1-888-254-0602.
Please also provide a copy of this form to: InflaRx GmbH at firstname.lastname@example.org.
References: 1. GOHIBIC Fact Sheet for Healthcare Providers, InflaRx GmbH. May 2023. Available at: https://www.fda.gov/media/166824/download. 2. Emergency Use Authorization (EUA) for Vilobelimab Letter of Authorization InflaRx GmbH. April 2023. Available at: EUA 118 InflaRx GOHIBIC LOA (04122023).docx (fda.gov). 3. GOHIBIC Fact Sheet for Patients and Caregivers, InflaRx GmbH. April 2023. Available at https://www.fda.gov/media/166821/download.