Sotrovimab injection is currently being studied for the treatment of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Clinical trial information is available at this time to support the use of sotrovimab for the treatment of COVID-19. More information is needed to know how well sotrovimab works for the treatment of COVID-19 and the possible adverse events from it.

Sotrovimab has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow certain non-hospitalized adults and children 12 years of age and older who have mild to moderate COVID-19 symptoms to receive sotrovimab injection.

IMPORTANT NOTICE On March 25, 2022, FDA updated the emergency use authorization (EUA) for sotrovimab stating that it is not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.

Sotrovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. It is used in people who have certain medical conditions that make them at higher risk for developing severe COVID-19 symptoms, including the need to be hospitalized from COVID-19 infection or death. Sotrovimab is in a class called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body in order to stop the spread of the virus.

Sotrovimab comes as a solution (liquid) to be mixed with additional liquid and then injected slowly into a vein by a doctor or nurse over 30 minutes. It is given as a one-time dose as soon as possible after a positive test for COVID-19 and within 10 days after the start of COVID-19 infection symptoms such as a fever, cough, or shortness of breath.

Sotrovimab injection may cause serious or life-threatening reactions during and after the infusion. A doctor or nurse will monitor you carefully while you are receiving this medication and for at least 1 hour after you receive them. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after the infusion: fever, difficulty breathing, chills, fatigue, chest pain, chest discomfort, weakness, confusion, nausea, headache, shortness of breath, wheezing, throat irritation, rash, hives, itching, flushing, muscle pain or dizziness, especially when standing up, sweating, or swelling of the face, throat, tongue, lips, or eyes. Your doctor may need to slow down your infusion or stop your treatment if you experience any of these side effects.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving sotrovimab injection,

• Tell your doctor and pharmacist if you are allergic to sotrovimab, any other medications, or any of the ingredients in sotrovimab injection. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: immunosuppressive medications such as cyclosporine (Gengraf, Neoral, Sandimmune), prednisone, and tacrolimus (Astagraf, Envarsus, Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had any medical conditions.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving sotrovimab, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Sotrovimab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Bleeding, bruising, pain, soreness, or swelling at injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• Fever, difficulty breathing, changes in heart rate, tiredness, weakness, or confusion

Sotrovimab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about sotrovimab injection.

You should continue to isolate as directed by your doctor and follow public health practices such as wearing a mask, social distancing, and frequent hand washing.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.