Vilobelimab

COVID-19 is a serious illness caused by a coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 spreads from one person to another through the air.

COVID-19 can impact your lungs or other organs. Symptoms can range from mild to severe and may include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The US Food and Drug Administration (FDA) has allowed the emergency use of vilobelimab to treat COVID-19 in hospitalized adults when treatment begins within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO, a heart-lung machine that helps increase oxygen in the blood). Vilobelimab has not been approved by the FDA to treat COVID-19.

Vilobelimab may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or information sheets.

Vilobelimab is given by injection into a vein by a healthcare provider in a hospital.

The US Food and Drug Administration (FDA) has allowed the emergency use of vilobelimab for treating COVID-19 in hospitalized adults if it is started within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO, a heart-lung machine that helps increase oxygen in the blood). Vilobelimab has not been approved by the FDA for treating COVID-19.

Tell your doctor if you have:

• allergies;
• an infection that is not COVID-19; or
• any serious illnesses.

Tell your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Vilobelimab may cause serious side effects. Call your doctor right away if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Common side effects of vilobelimab may include:

• confusion;
• constipation;
• rash;
• irregular heartbeats;
• pain, swelling, or warmth in one leg;
• pain and burning when you urinate;
• chest pain, breathing problems, shortness of breath;
• severe headache, blurred vision, pounding in your neck or ears;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• symptoms of sepsis--confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill; or
• symptoms of herpes virus--cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for COVID-19:

For investigational use only800 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).Comments:-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-productsUse: For the treatment of COVID-19 in hospitalized patients when initiated within 48 hours of receiving IMV or ECMO

In a medical setting, you are unlikely to miss a dose.

In a medical setting, an overdose will be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect vilobelimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.