Imdevimab Injection

What is this medication?

IMDEVIMAB (im DEV i mab) is a monoclonal antibody. It is used with another monoclonal antibody to treat COVID-19 in patients who are not hospitalized. It is also used to reduce the risk of getting COVID-19. It is for patients at risk of getting severe symptoms of COVID-19. It may decrease the risk of developing severe symptoms of COVID-19. It may also decrease the chance of going to the hospital. This medicine is not approved by the FDA. The FDA has authorized emergency use of this medicine during the COVID-19 pandemic.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• any allergies
• any serious illness
• have received a COVID-19 vaccine
• an unusual or allergic reaction to imdevimab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This drug is for infusion into a vein or injected under the skin. It is given by a health care provider in a clinic setting.

Talk to your pediatrician regarding the use of this drug in children. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

What may interact with this medication?

• COVID-19 vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this drug. Visit your health care provider for regular checkups. Tell your health care provider if your symptoms do not start to get better or if they get worse.

After receiving this medicine, wait at least 90 days before getting the COVID-19 vaccine. If you have already received your first dose of the COVID-19 vaccine, wait at least 90 days after getting this medicine before getting your second dose of vaccine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• infusion-related reactions (chest pain or chest tightness, chills, fever, flushing, stomach pain, trouble breathing)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• nausea
• pain, redness, or irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.