Drug Information

Imdevimab (Regn10987) (Eua)

What is IMDEVIMAB (REGN10987) (EUA)?

(IMDEVIMAB (REGN10987) (EUA)) The combination of casirivimab and imdevimab is a product that the FDA and Health Canada are allowing to be given for emergency/interim use to treat COVID-19. It is used by people 12 years of age and older who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 10 days, and are not hospitalized. This product is also being allowed to be used in the US to help prevent COVID-19 infection in people who have a high risk for infection after exposure to someone infected with COVID-19. Some conditions that increase risk of infection after exposure include: not being fully vaccinated, having had close contact, or being at high risk of close contact due to your housing conditions (such as a nursing home or prison). 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). 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 and from the Health Canada Patient Medication Information sheet. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form. 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.

How should I use IMDEVIMAB (REGN10987) (EUA)?

The combination of casirivimab and imdevimab is given one time by slow infusion into a vein by a healthcare professional. 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. In some cases, certain products may also be given by injection under the skin by a healthcare professional. The medication is given as a series of 4 injections into the abdomen, upper thighs, or the back of the upper arms. Each injection should be given in a different area of the body and the medication should not be injected into an area that is scarred, bruised, damaged, or tender. A healthcare professional will observe you for at least one hour after your injections in case you have serious side effects. Tell your doctor if your condition does not improve or if it gets worse.

What should I tell my health care provider before I take IMDEVIMAB (REGN10987) (EUA)?

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 (physical 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.

What may interact with IMDEVIMAB (REGN10987) (EUA)?

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.

What if I miss a dose of IMDEVIMAB (REGN10987) (EUA)?

Not applicable.

What side effects may I notice from receiving IMDEVIMAB (REGN10987) (EUA)?

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 or high blood pressure, dizziness, slow/fast/irregular heartbeat, chest pain, trouble breathing, fever, chills, nausea, headache, confusion, sweating, 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.

Where should I keep IMDEVIMAB (REGN10987) (EUA)?

Not applicable. This product is not stored at home.

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