The combination of casirivimab and imdevimab is an investigational drug product being studied in the US and Canada to treat coronavirus disease, also known as COVID-19. In the US, this product is not FDA-approved; however, it is FDA-authorized for emergency use to treat COVID-19. It is used by people over the age of 12 who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 10 days, and are not hospitalized. To receive this product you must also be at high risk for COVID-19 complications due to older age, obesity, or ongoing medical conditions (such as lung or heart disease or diabetes, among others). In Canada, the combination of casirivimab and imdevimab has not yet been authorized by Health Canada for emergency or conditional use. Talk to your doctor about the risks and benefits of treatment with casirivimab and imdevimab.
Casirivimab and imdevimab are antibodies which, when given soon after infection, can neutralize the coronavirus and may prevent worsening of COVID-19 symptoms. More information about casirivimab and imdevimab is available from the FDA Fact Sheet for Patients, Parents and Caregivers for Emergency Use, or should be provided by the doctor from the Informed Consent Form for a study.
There is limited information about how safe and effective the combination of casirivimab and imdevimab is for treating COVID-19. Study results show that casirivimab and imdevimab may help people who have recently tested positive for coronavirus stay out of the hospital. This product is not for use by people who are hospitalized due to COVID-19, or who need supplemental oxygen or a ventilator due to COVID-19.
The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of casirivimab and imdevimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.