vilobelimab 10 mg/mL intravenous solution (EUA)

Generic name:
Vilobelimab - injection

Pronunciation
(VIL-oh-BEL-i-mab)

Brand name(s)
Gohibic

Vilobelimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. It is used to treat people who are in the hospital and unable to breathe on their own (for example, being on a mechanical ventilator). Talk to your doctor about the risks and benefits of treatment with vilobelimab.

Vilobelimab belongs to a class of drugs known as monoclonal antibodies. It works by blocking the effects of a protein in the body's immune system that causes inflammation. This effect may prevent worsening of COVID-19. More information about vilobelimab is available from the FDA Fact Sheet for Patients and Caregivers provided by your health care professional. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form.

There is limited information about how safe and effective vilobelimab is for treating COVID-19. Study results show that vilobelimab may help decrease risk of death in certain people with COVID-19 who are in the hospital.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of vilobelimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

This medication is given by slow injection into a vein as directed by your doctor. It is infused by a health care professional usually over 30 to 60 minutes. Your doctor may direct you to receive up to 6 doses of this medication on certain days while you are in the hospital.

The number of doses you receive depends on your medical condition and response to treatment.

Tell your doctor if your condition does not get better or if it gets worse.

Although vilobelimab is used to treat COVID-19, there have been cases of other serious infections reported. Tell your doctor right away if you have any new or worsening signs of infection (such as sore throat that doesn't go away, fever, chills, cough, painful urination, sores around the mouth/genitals).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Information is limited and it is unknown at this time if vilobelimab causes other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Before using this medication, tell your doctor if you have any allergies. Vilobelimab may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how vilobelimab works, or how vilobelimab may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing (physical distancing), washing hands, and not sharing personal items.

Tell your doctor if you are pregnant or think you are pregnant. Vilobelimab should be used during pregnancy only if the possible benefits are greater than the possible risks.

It is unknown if vilobelimab passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. Information is limited and it is unknown at this time if vilobelimab has drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose information is not available at this time.

Not applicable.

Not applicable.

Not applicable. This medication is given in a hospital and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.