casirivimab

What is the most important information I should know about casirivimab?

Casirivimab has not been approved to treat coronavirus or COVID-19. It is not yet known if this medicine is an effective treatment for any condition.

The FDA has authorized emergency use of casirivimab in combination with imdevimab only in people with COVID-19 who are not in a hospital or using supplemental oxygen.

What is casirivimab?

Casirivimab is an experimental medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if casirivimab is a safe and effective treatment for any condition.

The US Food and Drug Administration (FDA) has authorized emergency use of casirivimab in combination with another medicine called imdevimab to treat mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Casirivimab with imdevimab is for use only in people who test positive for COVID-19 and have a high risk of symptoms becoming severe enough to need treatment in a hospital or with supplemental oxygen.

The risk of COVID-19 symptoms becoming severe may be higher in people with:

• a body mass index (BMI) of 35 or higher;
• chronic kidney disease;
• diabetes; or
• a weak immune system (caused by disease or by using certain medicine).

There also may be a higher risk of severe COVID-19 symptoms in adults who are:

• 65 years of age or older; or
• 55 years of age or older AND have heart disease, high blood pressure, or lung disease such as chronic obstructive pulmonary disease (COPD).

There also may be a higher risk of severe COVID-19 symptoms in children (12 and older weighing at least 88 lbs or 40 kg) who have:

• a BMI at or above the 85th percentile for age and gender;
• sickle cell disease;
• a heart problem;
• a neurodevelopmental disorder such as cerebral palsy;
• asthma or other chronic breathing disorder needing daily medication to control; or
• a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

Casirivimab and imdevimab are mixed together into a single solution to be injected into a vein. The mixture of these two medicines is called Regen-COV.

Casirivimab and imdevimab 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.

Casirivimab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving casirivimab?

Tell your doctor if you have ever had:

• any allergies; or
• any serious or chronic illness.

Tell your doctor if you are pregnant or breastfeeding.

How is casirivimab given?

Regen-COV must be given as a combination. Casirivimab should not be used alone.

Regen-COV is given as an infusion into a vein. A healthcare provider will give you this injection.

Regen-COV must be given slowly, and the infusion can take at least 1 hour to complete.

Regen-COV is usually given as only one dose. The injection should be given within 10 days of when you first started having symptoms of COVID-19.

You will be watched closely for at least 1 hour after the injection, to make sure you do not have an allergic reaction.

Regen-COV also may not keep you from becoming infected with coronavirus again. Being treated with this drug combination could also affect your body's immune response to a coronavirus vaccine. Casirivimab and imdevimab are still being studied and all of their risks are not yet known.

What happens if I miss a dose?

Regen-COV is given in a single dose and does not have a daily dosing schedule.

What happens if I overdose?

What should I avoid after receiving casirivimab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of casirivimab?

• throat irritation, swelling in your face or throat;
• fever, chills, sweating;
• a rash or itching;
• dizziness, a light-headed feeling (like you might pass out);
• wheezing, shortness of breath;
• nausea, vomiting;
• chest pain, fast or slow heartbeats, pounding in your neck or ears;
• headache, change in your mental status;
• muscle pain; or
• pain, bruising, swelling, or skin changes where the medicine was injected.

Less serious side effects may also occur, or you may have none at all. Not all possible side effects are known.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect casirivimab?

Other drugs may affect casirivimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about casirivimab.