FDA issued an emergency use authorization for the investigational monoclonal antibody sotrovimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years of age weighing ≥40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy (or an increase in baseline oxygen flow rate in those on chronic oxygen therapy because of an underlying non-COVID-19 related comorbidity) due to COVID-19. A benefit of sotrovimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as sotrovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Health care provider fact sheet - https://www.fda.gov/media/149534/download
Patient fact sheet - https://www.fda.gov/media/149533/download
Frequently Asked Questions for sotrovimab - https://www.fda.gov/media/149535/download
Further information may be found at:
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/results?cond=Covid19&term=vir-7831&cntry=&state=&city=&dist=
IDSA: https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/
NIH: https://www.covid19treatmentguidelines.nih.gov/
In Canada, Health Canada has permitted an interim authorization for the use of sotrovimab as of July 2021. Further information is available at https://covid-vaccine.canada.ca/sotrovimab/product-details.
COVID-19, mild to moderate:
Note: Sotrovimab is only for use in patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization; refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease. Sotrovimab is NOT authorized for use in patients who are hospitalized due to COVID-19 or who require new or increased oxygen therapy due to COVID-19 outside of a clinical trial; outcomes may be worse if used in patients requiring high-flow oxygen or mechanical ventilation (FDA 2021). Data are insufficient to recommend for or against the use of sotrovimab for the treatment of COVID-19 in pediatric patients; decision for use should be made on a case-by-case basis in consultation with pediatric infectious disease experts (NIH 2021). Development of SARS-CoV-2 variants with reduced susceptibility to sotrovimab may increase risk of treatment failure; consider local prevalence of variants when evaluating treatment options. Further information on variants may be found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html.
Children ≥12 years and Adolescents weighing ≥40 kg: IV: 500 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset. Note: Sotrovimab has not been studied in pediatric patients; emergency use authorization from the FDA is based on likelihood of similar exposures in patients ≥12 years of age weighing ≥40 kg (FDA 2021).
Altered kidney function: Children ≥12 years and Adolescents weighing ≥40 kg: IV: No dosage adjustment recommended (FDA 2021).
There are no dosage adjustments provided in the fact sheet for health care providers (has not been studied).
(For additional information see "Sotrovimab (United States: Authorized for use): Drug information")
COVID-19, mild to moderate (off-label use):
Note: Reserve for patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization; refer to the FDA fact sheet for health care providers for more information on patients at high risk for progression to severe disease. Use is not authorized for patients who are hospitalized or require new or increased oxygen therapy due to COVID-19; outcomes may be worse if used in patients requiring high-flow oxygen or mechanical ventilation (FDA 2021; IDSA [Bhimraj 2021]; NIH 2021).
IV: 500 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset (FDA 2021; IDSA [Bhimraj 2021]; NIH 2021). Note: Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options (FDA 2021; IDSA [Bhimraj 2021]; NIH 2021). Further information may be found at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html.
No dosage adjustment recommended (FDA 2021).
There are no dosage adjustments provided (has not been studied) (FDA 2021).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Generic: 500 mg/8 mL (8 mL)
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Generic: 500 mg/8 mL (8 mL)
Investigational agent; approved for emergency use authorization by the FDA May 2021.
Sotrovimab is not commercially available; it is available as part of ongoing clinical trials and under an emergency use authorization (EUA) from the FDA. The Department of Health and Human Services will determine weekly distribution amounts for each state/territory based on weekly reports of new COVID-19 cases and hospitalizations, in addition to data on inventories and use submitted to the federal government. State and territorial health departments will identify which sites in their respective jurisdictions receive product as well as the amount they will receive.
As part of the EUA, fact sheets pertaining to emergency use of sotrovimab are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for sotrovimab administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets and EUA letter may be accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with sotrovimab use by either submitting a MedWatch form (https://www.fda.gov/medwatch/report.htm) or FDA Form 3500 (health professional) by mail or fax (1-800-FDA-0178); a copy of all MedWatch forms should also be provided to GlaxoSmithKline.
Parenteral: IV: Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature (~15 minutes) prior to administration. After priming with NS, administer as an IV infusion through a PVC or polyolefin (PO) infusion set over 30 minutes; it is strongly recommended to use a 0.2 micron polyethersulfone filter.
Infuse the entire content of the bag to avoid underdosage; flush line with NS following completion of infusion. Slow or interrupt infusion and treat as appropriate if the patient develops any signs of infusion-associated events (eg, fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia, chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, diaphoresis); if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and provide emergency care (FDA 2021).
IV: If diluted solution is refrigerated prior to administration, allow solution to warm to room temperature for ~15 minutes prior to administration. Administer as an IV infusion over 30 minutes through a PVC or polyolefin infusion set containing a 0.2-micron polyethersulfone filter. Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage. Slow or stop infusion and treat as appropriate if an infusion-related reaction occurs. Flush infusion line with D5W or NS following completion of infusion (FDA 2021).
Refrigerate intact vials at 2°C to 8°C (36°F to 46°F); protect from light. Do not freeze or shake (FDA 2021).
Diluted infusion solution should be administered immediately. If immediate administration is not possible, store diluted sotrovimab infusion solution for up to 24 hours refrigerated at 2°C to 8°C (36°F to 46°F) or up to 6 hours at up to 25°C (77°F), including transportation and infusion time. If refrigerated, allow infusion solution to warm to room temperature for ~15 minutes prior to administration (FDA 2021).
Investigational agent for treatment of mild to moderate COVID-19 in patients with positive SARS-CoV-2 direct viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death (FDA issued emergency use authorization [EUA] in ages ≥12 years weighing ≥40 kg and adults).
Per the EUA, the following factors, in addition to other potential factors (eg, race, ethnicity), may place patients at high risk for progressing to severe COVID-19 (FDA 2021):
• Overweight or obesity (eg, BMI >25 kg/m2; BMI ≥85th percentile for age and gender, based on CDC growth charts, for those 12 to 17 years of age)
• Pregnancy
• Chronic kidney disease
• Diabetes
• Immunosuppression (due to treatment or underlying disease)
• Cardiovascular disease (including congenital heart disease) or hypertension
• Chronic lung diseases (eg, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
• Sickle cell disease
• Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies)
• Medical technology dependence (eg, tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])
• Older age (eg, ≥65 years)
Sotrovimab is NOT authorized for use in patients who are hospitalized due to COVID-19 or who require new or increased oxygen therapy due to COVID-19.
Hypersensitivity reactions, including anaphylaxis and infusion related reactions, have occurred with sotrovimab. Reactions may be severe or life threatening. Infusion related reactions may include arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, hypotension, hypertension, bronchospasm, difficulty breathing, altered mental status, angioedema, throat irritation, rash including urticaria, vasovagal reactions (eg, presyncope, syncope), among other reactions.
Mechanism: Immediate hypersensitivity reactions (eg, anaphylaxis): Non–dose-related; immunologic; IgE-mediated with specific antibodies formed against a drug allergen (Blumenthal 2019).
Onset: Immediate hypersensitivity reactions (eg, anaphylaxis): Rapid; IgE-mediated reactions generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Blumenthal 2019, NICE 2014). Infusion related reactions: Rapid; occurred during the infusion and up to 24 hours after the infusion of sotrovimab.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Pruritus, skin rash
Gastrointestinal: Diarrhea
Hypersensitivity: Anaphylaxis, hypersensitivity reaction (including severe hypersensitivity reaction)
Nervous system: Chills, dizziness
Miscellaneous: Fever, infusion related reaction (including severe infusion related reaction)
History of anaphylaxis to sotrovimab or any component of the formulation.
Canadian labeling: Hypersensitivity to sotrovimab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Infusion-related reactions (eg, fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia [eg, atrial fibrillation, sinus tachycardia, bradycardia], chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions [eg, presyncope, syncope], dizziness, diaphoresis) have been observed with administration of sotrovimab and up to 24 hours after the infusion. These reactions may be severe or life threatening. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. Serious hypersensitivity reaction, including anaphylaxis, may also occur with administration of sotrovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care (FDA 2021).
Other warnings/precautions:
• Antiviral resistance: Development of SARS-CoV-2 variants with reduced susceptibility to sotrovimab may potentially increase risk of treatment failure; consider local prevalence of SARS-CoV-2 variants, if available, when evaluating treatment options (FDA 2021; NIH 2021).
• Clinical worsening: Clinical worsening of COVID-19, including signs or symptoms of altered mental status, arrhythmia (atrial fibrillation, bradycardia, tachycardia), fatigue, fever, hypoxia, or increased respiratory difficulty, has been reported after administration of SARS-CoV-2 monoclonal antibodies; some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to COVID-19 progression (FDA 2021).
• Limitations of use: Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID related comorbidity. Benefit of treatment has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen therapy or mechanical ventilation (FDA 2021).
None known.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Reproductive toxicity studies have not been conducted (FDA 2021).
Sotrovimab is currently available under FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19. Reproductive toxicity studies have not been conducted (FDA 2021).
Sotrovimab is a humanized monoclonal antibody (IgG1). Human IgG is known to cross the placenta; exposure is dependent upon the IgG subclass, maternal serum concentrations, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). The potential benefits or risks of in utero exposure to sotrovimab to the fetus are not known (FDA 2021).
The risk of severe illness from COVID-19 infection is increased in pregnant patients, and pregnancy is one of the high-risk medical conditions defined by the CDC. An increased risk of adverse pregnancy outcomes may also occur in COVID-19 positive patients with symptomatic infection. These include preterm birth, preeclampsia, coagulopathy, and stillbirth. Pregnant patients with symptomatic COVID-19 infection are more likely to require ICU admission, mechanical ventilation, and ventilatory support (ECMO) compared to nonpregnant symptomatic patients. Maternal age and comorbidities may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2021; NIH 2021).
In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients (NIH 2021). Monoclonal antibodies should not be withheld from pregnant patients when otherwise appropriate (ACOG 2021; NIH 2021). Pregnancy is one of the medical conditions listed in the EUA eligibility criteria for sotrovimab, and this is one of the recommended agents for pregnant patients, particularly those with ≥1 additional risk factor (ACOG 2021; FDA 2021; NIH 2021). According to the EUA, dose adjustments are not recommended for patients who are pregnant (FDA 2021). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have developed an algorithm to aid practitioners in assessing and managing pregnant patients with suspected or confirmed COVID-19 (https://www.acog.org/covid-19; https://www.smfm.org/covid19). Interim guidance is also available from the CDC for pregnant patients who are diagnosed with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/inpatient-obstetric-healthcare-guidance.html).
Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/).
Monitor for infusion-related reactions (eg, fever, chills, hypotension, rash, pruritus) and hypersensitivity/anaphylaxis during infusion and for 1 hour following infusion completion (FDA 2021).
Sotrovimab is a recombinant human IgG1k monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2. Sotrovimab inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes (FDA 2021).
Pediatric: Clinical trials have not been performed; serum exposures in patients ≥12 years of age and weighing ≥40 kg are expected to be similar to those observed in adults (FDA 2021).
Solution (Sotrovimab Intravenous)
500 mg/8 mL (per mL): $315.00
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