Due to the high frequency of the Omicron BA.2 sub-variant, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

Imdevimab is an experimental medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if imdevimab is a safe and effective treatment for any condition.

Imdevimab and casirivimab are also for use in people who have been exposed to COVID-19 and:

• are not fully vaccinated against COVID-19; or
• are vaccinated but may not have built up enough immunity (because they have certain diseases or use certain medicines), and have been or may be exposed to people who are infected with COVID-19.

Imdevimab and casirivimab are for use in adults and children at least 12 years old who weigh at least 88 pounds (40 kilograms).

The risk of COVID-19 symptoms becoming severe may be higher in people who:

• are overweight;
• have chronic kidney disease;
• have diabetes;
• have a weak immune system (caused by disease or by using certain medicine);
• have sickle cell disease;
• have a heart problem or high blood pressure;
• have a neurodevelopmental disorder such as cerebral palsy;
• have asthma or other chronic breathing disorder; or
• have a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

There also may be a higher risk of severe COVID-19 symptoms in pregnant women and in adults who are 65 and older.

Imdevimab and casirivimab are mixed together into a single solution called Regen-Cov.

Imdevimab and casirivimab have not been approved to treat coronavirus or COVID-19. However, these medicines may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. Regen-Cov is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

Imdevimab may also be used for purposes not listed in this medication guide.

Tell your doctor if you have ever had:

• a COVID-19 vaccine;
• a severe allergic reaction to a COVID-19 vaccine;
• any serious or chronic illness;
• any allergies; or
• if you are pregnant or breastfeeding.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but being treated with imdevimab and casirivimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

Use Imdevimab (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you have:

• throat irritation, swelling in your face or throat;
• dizziness, a light-headed feeling (like you might pass out);
• chest pain, wheezing, shortness of breath;
• fever, chills, sweating, nausea, flushing (sudden warmth, redness, or tingly feeling);
• fast or slow heartbeats, headache, pounding in your neck or ears;
• weakness, tiredness;
• rash, itching; or
• muscle pain.

Call your doctor if you have new or worsening symptoms after the infusion, such as fever, confusion, weakness, tiredness, trouble breathing, or fast or slow heartbeats.

Less serious side effects may also occur, or you may have none at all. Not all possible side effects are known.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.