Imdevimab

Generic name: imdevimab [ im-DEV-i-mab ]
Dosage form: injectable solution (1332 mg/11.1 mL; 300 mg/2.5 mL)

What is imdevimab?

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.

Warnings

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.

Before taking this medicine

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...