Sotrovimab
Generic name: sotrovimab [ soe-TROE-vi-mab ]
Dosage form: intravenous solution (500 mg/8 mL)
Drug class:Miscellaneous antivirals
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, sotrovimab 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.
Warnings
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.
Before taking this medicine
You should not use sotrovimab if you are allergic to it, or if you have ever had:
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 bei...
