sotrovimab

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

Due to the high frequency of the Omicron BA.2 sub-variant, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

What is sotrovimab?

Due to the high frequency of the Omicron BA.2 sub-variant, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

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

Sotrovimab is for use in adults and children at least 12 years old who weigh at least 88 pounds (40 kilograms).

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

• are overweight;
• have chronic kidney disease;
• have diabetes;
• have a weak immune system (caused by disease or by using certain medicine);
• have sickle cell disease;
• have a heart problem or high blood pressure;
• have a neurodevelopmental disorder such as cerebral palsy;
• have asthma or other chronic breathing disorder; or
• have a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

There also may be a higher risk of severe COVID-19 symptoms in pregnant women and in adults who are 65 and older.

Sotrovimab has not been approved to treat coronavirus or COVID-19. However, this medicine may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. Sotrovimab is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

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

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

• any serious or chronic illness;
• any allergies; or
• if you are pregnant or breastfeeding.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but being treated with sotrovimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

How is sotrovimab given?

Sotrovimab is usually given as only one dose as soon as possible after you test positive for COVID-19, or within 10 days after the start of symptoms.

Sotrovimab is injected into a vein by a healthcare provider.

Sotrovimab is injected slowly over 30 minutes. You will be watched for a short time to make sure you do not have an allergic reaction.

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

What happens if I miss a dose?

Sotrovimab is given in a single dose and does not have a daily dosing schedule.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving sotrovimab?

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

What are the possible side effects of sotrovimab?

• throat irritation, swelling in your face or throat;
• fast, slow, or uneven heart rate;
• confusion, dizziness, a light-headed feeling (like you might pass out);
• chest pain, wheezing, shortness of breath;
• fever, chills, sweating, nausea, weakness, tiredness;
• pounding in your neck or ears;
• rash, itching; or
• headache, muscle pain.

Common side effects may include:

• diarrhea; or
• rash.

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 sotrovimab?

Other drugs may affect sotrovimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about sotrovimab.