Pronunciation:

pe-MIV-i-bart

Brand Names:

• Pemgarda

Dosage Forms:

• Solution

Warnings:

Anaphylaxis has been observed with pemivibart in 0.6% (4/623) of participants in a clinical trial. Anaphylaxis was reported during the first and second infusion of pemivibart. Anaphylaxis can be life-threatening. Prior to administering pemivibart, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis. Administer pemivibart only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion. Discontinue pemivibart immediately if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Pemivibart injection is used to prevent coronavirus disease 2019 (COVID-19) in patients who are not infected, have had no recent exposure, or who have moderate to severe immune system problems (eg, cancer, HIV infection, patients who received an organ transplant, patients receiving treatment that weakens the immune system).

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 pemivibart injection in children younger than 12 years of age or weighing less than 40 kilograms (kg). 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 pemivibart 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:

• Allergy to polysorbate 80, history of—Use with caution. May increase risk for allergic reactions.

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 an IV catheter that is placed into one of your veins every 3 months. The medicine must be given slowly, so your IV will need to stay in place for at least 60 minutes.

This medicine comes with a Fact Sheet for Patients, Parents, 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 allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

Check with your doctor right away if you have back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, trouble breathing, or weakness. These may be symptoms of infusion-related reactions, which can be life-threatening and require immediate medical attention.

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

Back pain

body aches or pain

chest tightness

chills

cough

ear congestion

fever

flushing

headache

loss of voice

nausea and vomiting

sneezing

sore throat

stuffy or runny nose

trouble breathing

Less common

Diarrhea

general feeling of discomfort or illness

joint pain

loss of appetite

muscle aches and pains

shivering

sweating

trouble sleeping

unusual tiredness or weakness

Incidence not known

Difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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

Less common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.