Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vilobelimab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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