Applies to sotrovimab: parenteral solution concentrate for injection for iv infusion.
Special Alerts:
On March 25, 2022, FDA issued an update to the emergency use authorization (EUA) for sotrovimab based on new data showing that the current authorized dose of sotrovimab is unlikely to be effective against the Omicron BA.2 subvariant.15 16 Under the revised EUA, sotrovimab is no longer authorized for use at this time in geographic regions where infection is likely to have been caused by a SARS-CoV-2 variant that is not susceptible to this treatment.15 16 There are several other therapies (e.g., nirmatrelvir, remdesivir, bebtelovimab, molnupiravir) that are expected to be effective against the BA.2 subvariant, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether these treatments are suitable for their patients.15 FDA will continue to monitor the BA.2 subvariant in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available. Health care providers should also monitor the frequency of BA.2 in their region as they choose appropriate treatment options for their patients.15
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that sotrovimab is not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in certain outpatients. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Side effects include:
Data from an ongoing trial in outpatients with mild to moderate COVID-19 (NCT04545060; COMET-ICE) indicate most common treatment-emergent adverse events in those treated with sotrovimab were mild or moderate (grade 1 or 2) rash (2%) and diarrhea (1%). No other treatment-emergent adverse events reported more frequently in patients who received sotrovimab compared with placebo.
