Regen-Cov
Generic name: casirivimab and imdevimab [ KAS-i-RIV-i-mab-and-im-DEV-i-mab ]
Drug class:Antiviral combinations
What is Regen-Cov?
Regen-Cov injection contains a combination of casirivimab and imdevimab, either supplied mixed in one vial or in two separate injection vials.
Regen-Cov is an investigational medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if Regen-Cov is safe and effective.
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 emergency use authorization (EUA) until further notice by the US FDA.
Regen-Cov is 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.
Regen-Cov is 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.
Casirivimab and imdevimab are mixed together into a single solution called Regen-Cov.
Regen-Cov has 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.
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
To make sure Regen-Cov is safe for you, tell your doctor if you have:
a COVID-19 vaccine;
a severe allergic reaction to a COVID-19 vaccine;
any serio...
