REGEN-COV (EUA)

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.

The combination of casirivimab and imdevimab is given one time by injection into a vein by a healthcare professional. It is infused over at least one hour. A healthcare professional will observe you during your infusion and for at least another hour after your treatment in case you have serious side effects.

Pain, soreness, swelling, or bruising of the skin at the injection site may occur. If you notice any of these effects, tell your healthcare professional promptly.

An infusion reaction may occur while this product is being given, causing symptoms such as low blood pressure, dizziness, trouble breathing, fever, chills, nausea, headache, or muscle pain. Get medical help right away if you notice any of these symptoms. A slower rate of infusion may help to lessen the risk of this reaction.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Information is limited and it is unknown at this time if casirivimab and imdevimab cause other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Before using this medication, tell your doctor if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how casirivimab and imdevimab work, or how casirivimab and imdevimab may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing, washing hands and not sharing personal items.

Tell your doctor if you are pregnant or think you are pregnant. The combination of casirivimab and imdevimab should be used during pregnancy only if the possible benefits are greater than the possible risks.

It is unknown if casirivimab and imdevimab pass into breast milk. The risks of breast-feeding while infected with COVID-19 and while using this product should be discussed with the doctor.

Not applicable. This product is not stored at home.

Drug interactions may change how medications work or increase the risk for serious side effects. Information is limited and it is unknown at this time if casirivimab and imdevimab have drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor. Do not start, stop or change the dosage of any medicine without your doctor's approval.

Overdose information is not available at this time.

Not applicable.

Not applicable.