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Mechanism of Action
NOTE: Patients may be at high risk for progressing to severe COVID-19 if they meet at least 1 of the following criteria:
In addition, other medical conditions or factors (e.g., race, ethnicity) may also place individual patients at high risk, and authorization of sotrovimab under the EUA is not limited to only those medical conditions or factors listed above. Health care providers are advised to consider the benefit-to-risk of an individual patient.
NOTE: Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation may be associated with worsening clinical outcomes.
NOTE: The National Institutes of Health (NIH) COVID-19 treatment guidelines state that anti-SARS-CoV-2 antibodies be considered for use in high risk persons with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19. Additionally, although these antibodies are not authorized for use in patients hospitalized due to severe COVID-19, the NIH suggests that they may be available through expanded access programs for patients who have not developed an antibody response or who are not expected to mount an effective immune response to SARS-CoV-2 infection.
NOTE: Health care providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Current variant frequency data are available at: www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html. In vitro studies indicate that sotrovimab remains active against the Omicron variant (B.1.1.529/BA.1).
NOTE: Due to the Omicron variant becoming the dominant variant in many parts of the United States, the NIH has issued a statement to provide guidance on treating nonhospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. The NIH recommends using 1 of the following therapeutics with expected activity against the Omicron variant (listed in order of preference):
Sotrovimab should be administered in a setting where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Patients should be monitored during the infusion and observed for at least 1 hour after the infusion.
NOTE: There may be logistical or supply constraints that make it impossible to offer the available therapy to all eligible patients, making patient triage necessary. Health care providers should prioritize their use for patients at highest risk of clinical progression. Information on which individuals might receive the greatest benefit from anti-SARS-CoV-2 therapeutics for treatment or prevention can be obtained from www.covid19treatmentguidelines.nih.gov/therapies/statement-on-patient-prioritization-for-outpatient-therapies. Health care providers are advised to consider the benefit-risk for each individual patient.
500 mg as a single intravenous infusion over 30 minutes. Administer the infusion as soon as possible after the positive test for SARS-CoV-2 and within 10 days of symptom onset. 
500 mg as a single intravenous infusion over 30 minutes. Administer the infusion as soon as possible after the positive test for SARS-CoV-2 and within 10 days of symptom onset.  According to the National Institutes of Health (NIH) COVID-19 treatment guidelines, there are insufficient pediatric data to recommend either for or against the routine use of anti-SARS-CoV-2 antibodies in high risk pediatric patients with mild to moderate COVID-19. The NIH recommends the use of these antibodies be considered on a case-by-case basis in consultation with a pediatric infectious diseases specialist.
40 kg or more: 500 mg IV.
less than 40 kg: Use not authorized.
12 years and weighing 40 kg or more: 500 mg IV.
12 years and weighing less than 40 kg: Use not authorized.
1 to 11 years: Use not authorized.
Use not authorized.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
No dosage adjustments are needed.
Sotrovimab is an investigational human immunoglobulin G-1 (IgG1-kappa) monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is not an FDA-approved drug; however, it has been authorized by the FDA for emergency treatment of mild to moderate coronavirus diseases 2019 (COVID-19) in patients (12 years and older weighing at least 40 kg) with positive SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19. Sotrovimab is NOT authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation may be associated with worsening clinical outcomes. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend using anti-SARS-CoV-2 monoclonal antibodies (including sotrovimab) to treat nonhospitalized patients with mild to moderate COVID-19 who are at high risk of clinical progression as defined by the Emergency Use Authorization (EUA) criteria. Anti-SARS-CoV-2 antibodies should also be considered for use in high risk persons with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19. While these antibodies are not authorized for use in patients hospitalized due to severe COVID-19, they may be available through expanded access programs for patients who have not developed an antibody response or who are not expected to mount an effective immune response to SARS-CoV-2 infection. Anti-SARS-CoV-2 antibodies should be started as soon as possible after positive test results for SARS-CoV-2 and within 10 days of symptom onset. In situations where it is necessary to triage eligible patients (i.e., logistical or supply constraints), the NIH suggests prioritizing treatment to unvaccinated/incompletely vaccinated individuals or vaccinated individuals not expected to mount an adequate immune response over vaccinated individuals who are immunocompetent. In addition, the NIH also recommends prioritizing use in those patients at highest risk of clinical progression as defined by the Centers for Disease Control and Prevention (CDC). These considerations should NOT limit the use of anti-SARS-CoV-2 antibodies when there are no logistical constraints. The use and timing of anti-SARS-CoV-2 antibodies should not be affected by prior exposure to the COVID-19 vaccine. Conversely, for patients who receive anti-SARS-CoV-2 antibodies, defer administration of the COVID-19 vaccination for at least 30 days (if antibodies were given as post-exposure prophylaxis) or 90 days (if antibodies were given as treatment). This deferment is as a precaution to avoid interference with vaccine-induced immune responses; however, if the vaccine is administered within the deferral period (i.e., 30 or 90 days), the vaccine dose does NOT need to be repeated.
NOTE: Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron SARS-CoV-2 variant (B.1.1.529/BA.1).
For storage information, see the specific product information within the How Supplied section.
NOTE: Sotrovimab is not an FDA-approved medication; however, it has been authorized for use under an Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in patients with positive SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death. Under the EUA, health care providers are required to communicate to the patient, parent, or caregiver information consistent with the "Fact Sheet for Patients, Parents, and Caregivers" prior to the patient receiving treatment; such information includes the following:
NOTE: Under the EUA, health care providers are required to report all medication errors and serious adverse events potentially related to sotrovimab therapy within 7 calendar days from the onset of the event.
Preparation and Dilution:
Adverse reactions that developed within 24 hours of sotrovimab treatment during the COMET-ICE trial (i.e., non-hospitalized patients) included fever, chills, dizziness, dyspnea, pruritus, rash (1%), and infusion-related reactions (1%). Additionally, 2% of patients in the sotrovimab group and 1% of patients who received the placebo developed hypersensitivity reactions; none of which required pausing or discontinuation of the infusions. All the reported events in this trial were mild to moderate in severity (Grade 1 or 2). In a different trial involving hospitalized patients, 1 patient experienced anaphylactic or anaphylactoid reactions during the infusion. In this case, the infusion was immediately stopped and the patient recovered following treatment with 2 doses of epinephrine. Other serious infusion-related reactions observed in hospitalized recipients of sotrovimab included Grade 3 or 4 bronchospasm and dyspneas; however, these events were also reported following infusion of the placebo.
Diarrhea was reported by 2% of patients treated with sotrovimab during the COMET-ICE trial. In all patients, the severity of the diarrhea was mild to moderate (Grade 1 or 2).
Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy for COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 if already on chronic oxygen therapy for an underlying condition. Use of the drug in hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation may be associated with worsening clinical outcomes. Recipients of anti-SARS-CoV-2 monoclonal antibodies, such as sotrovimab, have experienced fever, hypoxia, increased respiratory difficulty, arrythmia exacerbation, fatigue, and altered mental status; some of these events required hospitalization. It is not known if these events were related to administration of the antibody or progression of the COVID-19.
Infusion-related reactions have been observed during and up to 24 hours after treatment with sotrovimab; these reactions may be severe or life-threatening. Signs and symptoms of these reactions include fever, chills, nausea, headache, bronchospasms, dyspnea, reduced oxygen saturation, fatigue, arrhythmia exacerbation (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, hypotension, hypertension, angioedema, throat irritation, rash, urticaria, pruritus, myalgia, dizziness, syncope, and diaphoresis. If an infusion-related reaction develops, consider slowing or stopping the infusion and administer appropriate medications and supportive care. Similarly, serious hypersensitivity reactions, including anaphylaxis, have been observed with sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue treatment and initiate appropriate medications and supportive care.
There are insufficient data regarding the use of sotrovimab during pregnancy to determine a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, sotrovimab has the potential to be transferred from the mother to the developing fetus. It is unknown if this potential in utero transfer provides any therapeutic benefit or risk to the fetus. According to the manufacturer, sotrovimab should be administered during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus. The National Institutes of Health (NIH) COVID-19 treatment guidelines recommend anti-SARS-CoV-2 monoclonal antibodies not be withheld from a pregnant woman at high risk of progressing to severe COVID-19 if the clinician thinks that the potential benefit outweighs potential risk.
There are no data regarding the presence of sotrovimab in human milk, the effects on the breast-fed infant, or the effects on milk production; however, maternal immunoglobulin G (IgG) is known to be present in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, the potential for viral transmission to SARS-CoV-2-negative infants, and the risk of an untreated or inadequately treated condition. Lactating mothers are advised to follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
Sotrovimab is a recombinant human immunoglobulin G-1 (IgG1-kappa) monoclonal antibody used as an antiviral medication to target severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This antibody binds to an epitope on the spike protein receptor binding domain (RBD) of SARS-CoV-2, where it inhibits an undefined step that occurs after viral attachment but before fusion of the viral and host cell membranes. In cell cultures, sotrovimab elicited antibody-dependent cell-mediated cytotoxicity (ADCC) using human natural killer (NK) cells and antibody-dependent cellular phagocytosis (ADCP) using CD14 monocytes. The average 50% effective concentration (EC50) of sotrovimab in neutralizing SARS-CoV-2 in Vero cells is 100.1 ng/mL and the average EC90 is 186.3 ng/mL.
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Health care providers should refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions. In cell cultures, epitope amino acid substitutions P337H/L/R/T, E340A/K/G, and K356T resulted in reduced susceptibility to sotrovimab: E340K (more than 297-fold), P337R (more than 276-fold), P337L (180-fold), E340A (more than 100-fold), E340G (27-fold), P337H (7.5-fold), K356T (5.9-fold), and P337T (5.4-fold). However, neutralization data for SARS-CoV-2 variant substitutions identified through global surveillance have found no change in susceptibility (i.e., less than 5-fold reduction) to sotrovimab. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron SARS-CoV-2 variant (B.1.1.529/BA.1). The variants and key substitutions are as follows:
Sotrovimab is administered via intravenous infusion. The monoclonal antibody has a mean steady-state volume of distribution of 8.1 L, and is degraded by proteolytic enzymes that are distributed throughout the body. The mean systemic clearance is 125 mL/day and the median terminal half-life is approximately 49 days.
Affected cytochrome P450 isoenzymes: none
Data from the COMET-ICE study found the geometric mean maximum plasma concentration (Cmax) after a 1 hour sotrovimab intravenous infusion to be 117.6 mcg/mL (n = 290, CV% 46.5), and the geometric mean Day 29 concentration to be 24.5 mcg/mL (n = 372, CV% 42.4).
Monoclonal antibodies with molecular weights greater than 69 kDa do not undergo renal elimination. Therefore, neither renal impairment nor the presence of dialysis are expected to impact the pharmacokinetics of sotrovimab (149 kDa).
Administration of the recommended dose to pediatric patients ages 12 years and older who weigh at least 40 kg is expected to result in serum sotrovimab exposures that are comparable to those observed in adults.
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