Pronunciation:

vil-oh-BEL-i-mab

Brand Names:

• Gohibic

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Vilobelimab injection is used to treat coronavirus disease 2019 (COVID-19) in hospitalized patients who received supplemental oxygen and mechanical ventilation within 48 hours.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of vilobelimab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vilobelimab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection, active (eg, bacteria, virus, fungus), active—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for at least 30 to 60 minutes.

This medicine comes with a Fact Sheet for Patients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious infections. Check with your doctor right away if you have cough or hoarseness, fever or chills, lower back or side pain, or painful or difficult urination.

This medicine may cause serious allergic reaction, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have difficulty swallowing, fast heartbeat, skin rash, itching, or redness, swelling of the face, throat, or tongue, or trouble breathing.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Anxiety

bladder pain

bloody or cloudy urine

blurred vision

burning or stinging of the skin

chest pain or tightness

confusion

cough

difficult, burning, or painful urination

dizziness

fainting

fast heartbeat

fever or chills

frequent urge to urinate

hallucinations

headache

holding false beliefs that cannot be changed by fact

lightheadedness

lower back or side pain

nervousness

pain, redness, or swelling in the arm or leg

painful cold sores or blisters on the lips, nose, eyes, or genitals

pounding in the ears

rapid, shallow breathing

slow or fast heartbeat

sore throat

trouble breathing

unusual excitement, nervousness, or restlessness

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

fast, pounding, or irregular heartbeat or pulse

palpitations

pinpoint red spots on the skin

sneezing

unusual bleeding or bruising

Incidence not known

Difficulty in swallowing

skin itching, rash, or redness

swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Constipation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.