Gohibic

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

COVID-19 can affect your lungs or other organs. Symptoms can be mild or 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 authorized the emergency use of vilobelimab to treat COVID-19 in hospitalized adults when treatment starts within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO, a heart-lung machine that helps increase oxygen in the blood). Gohibic has not been approved by the FDA to treat COVID-19.

Gohibic may also be used for purposes not listed in this medication guide.

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

Tell your doctor if you have:

• allergies;
• an infection other than COVID-19; or
• any serious illnesses.

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

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

Gohibic 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 Gohibic 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 FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Gohibic is injected into a vein by a healthcare provider in a hospital.

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

In a medical setting, an overdose would be handled promptly.

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

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