Injection, 500 mg, for intravenous use
Emergency Use Authorization (EUA) for a Treatment of COVID-19
Important information about sotrovimab
- Sotrovimab is an investigational medicine (still being studied) and has not been approved by FDA. The FDA has made sotrovimab available under an emergency access mechanism called Emergency Use Authorization (EUA).
- The EUA for sotrovimab is in effect for the duration of the COVID-19 declaration justifying emergency use of these medicines, unless terminated or revoked (after which the products may no longer be used).
For more information, please access the Sotrovimab Patient Guide, or contact 1-866-GSK-COVID (866-475-2684).
Get the Facts
Get the Facts
What is sotrovimab?
Sotrovimab is an investigational medicine used to treat mild-to-moderate symptoms of COVID‑19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk of progression to severe COVID-19, including hospitalization or death. Sotrovimab is still being studied, and there is limited information about the safety and effectiveness.
Who is at risk?
The following medical conditions or other factors may place adults and pediatric patients (12 to 17 years of age weighing at least 40 kg) at higher risk for progression to severe COVID-19:
- Older age (for example, ≥65 years of age)
- Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if 12 to 17, with BMI ≥85th percentile for their age and gender based on CDC growth charts)
- Chronic kidney disease
- Immunosuppressive disease or immunosuppressive treatment
- Heart disease (including congenital heart disease) or high blood pressure
- Chronic lung disease (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])
Other medical conditions or factors (for example, race or ethnicity) may also place patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above.
Talk to your doctor to see if you may be at high risk for progression to COVID-19. Tell your doctor about all of your medical conditions, including if you:
- Have any allergies
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
- Have any serious illnesses
- Are taking any medicines (prescription, over-the-counter, vitamins, or herbal products)
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus. It is thought to spread mainly through close contact from person to person. People who are closer than 6 feet from the infected person are most likely to get infected.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, diabetes, for example, and other conditions including obesity, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19.
Common symptoms of COVID-19
The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure.
There is a wide range of COVID-19 symptoms, and they may differ from person to person. Many of the symptoms are similar to those associated with the common cold, allergies, or the flu. If you think you may have COVID-19, it’s important to get tested to confirm the diagnosis.
Serious illness, including breathing problems, can occur and may cause your other medical conditions to become worse.
What are the important possible side effects of sotrovimab?
Possible side effects of sotrovimab are:
Allergic reactions. Allergic reactions can happen during and after infusion with sotrovimab. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever; difficulty breathing; low oxygen level in your blood; chills; tiredness; fast or slow heart rate; chest discomfort or pain; weakness; confusion; nausea; headache; shortness of breath; low or high blood pressure; wheezing; swelling of your lips, face, or throat; rash including hives; itching; muscle aches; dizziness; feeling faint; and sweating.
The side effects of getting any medicine through a vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.
These are not all the possible side effects of sotrovimab. Not many people have been given sotrovimab. Serious and unexpected side effects may happen. Sotrovimab is still being studied, so it is possible that all of the risks are not known at this time.
It is possible that sotrovimab could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, sotrovimab may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.
How do I pay for sotrovimab?
The cost of sotrovimab may vary depending on your individual insurance plan. That’s why understanding your insurance is important.
GSK may be able to help eligible commercially insured patients with their out-of-pocket costs, subject to program rules and limitations. Please call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) for questions regarding the co-pay program eligibility requirements and how to enroll.
You can also learn more by accessing the GSK-Co-pay Program for Sotrovimab Patients brochure and enrollment form below.
Where can I find sotrovimab?
Talk to your doctor about if sotrovimab may be right for you. If your doctor determines that you should be treated with sotrovimab, call the COVID Contact Center at 1-866-GSK-COVID (866-475-2684) to find sotrovimab near you.
How can I learn more?
- Ask your healthcare provider about sotrovimab
- Call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684)
- Visit the National Institutes of Health website
- Visit the Department of Health and Human Services website
- Visit the Centers for Disease Control and Prevention (CDC) website
- Contact your local or state public health department
- Read the patient fact sheet in English or Spanish
- Read the FDA Letter of Authorization