Sotrovimab (Monograph)

Drug class: Monoclonal Antibodies
- SARS-CoV-2-specific Monoclonal Antibody

Introduction

Antiviral; recombinant human IgG₁κ neutralizing monoclonal antibody specific for SARS-CoV-2 virus.

Uses for Sotrovimab

Coronavirus Disease 2019 (COVID-19)

Being investigated for and has been used in the treatment of COVID-2019^{† [off-label]} caused by SARS-CoV-2.

One of several SARS-CoV-2-specific monoclonal antibodies being evaluated for treatment of COVID-19.

Although efficacy and safety not definitely established, sotrovimab is available under an FDA emergency use authorization (EUA) for treatment of mild to moderate COVID-19 in certain outpatients at high risk for progression to severe COVID-19, including hospitalization or death.

On May 26, 2021, FDA issued an EUA that permits use of sotrovimab for treatment of mild to moderate COVID-19^{† [off-label]} in adults and pediatric patients ≥12 years of age weighing ≥40 kg with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death. The EUA requires that the drug be administered by a health care provider in an appropriate setting via IV infusion using the dosage recommended in the EUA. (See Dosage and Administration.)

FDA issued the EUA for sotrovimab after concluding that emergency use of the drug for treatment of COVID-19 met the criteria for issuance of an EUA for the following reasons: SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness; based on the totality of scientific evidence available to FDA, it is reasonable to believe that sotrovimab may be effective in treating mild to moderate COVID-19 in adults and pediatric patients ≥12 years of age weighing ≥40 kg who have positive results of direct SARS-CoV-2 viral testing and are at high risk for progression to severe COVID-19, including hospitalization or death, and, when used under the conditions described in the EUA, the known and potential benefits of the drug outweigh the known and potential risks; and there are no adequate, approved, and available alternatives to the emergency use of sotrovimab for the treatment of COVID-19 in such patients.

When determining appropriate use of sotrovimab under the EUA, FDA states consider the following medical conditions and other factors that may place adults and pediatric patients ≥12 years of age at higher risk for progression to severe COVID-19: older age (e.g., ≥65 years of age); obesity or being overweight (e.g., body mass index [BMI] >25 kg/m² or, in those 12–17 years of age, BMI ≥85th percentile for their age and gender based on CDC growth charts); pregnancy; chronic kidney disease; diabetes mellitus; immunosuppressive disease or immunosuppressive therapy; cardiovascular disease (including congenital heart disease) or hypertension; chronic lung disease (e.g., COPD, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension); sickle cell disease; neurodevelopmental disorders (e.g., cerebral palsy) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes, severe congenital anomalies); or medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive-pressure ventilation not related to COVID-19).

FDA also states use of sotrovimab under the EUA is not limited only to the medical conditions and factors listed above; other medical conditions and factors (e.g., race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19. Consider the benefits versus risks for the individual patient when making treatment decisions regarding use of FDA-authorized SARS-CoV-2-specific monoclonal antibodies, including sotrovimab. Additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19 is available at [Web].

Sotrovimab is not authorized under the EUA for use in patients who are hospitalized due to COVID-19, require oxygen therapy and/or respiratory support due to COVID-19, or are on chronic oxygen therapy due to an underlying non-COVID-19-related comorbidity and require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19. Benefit not observed when used in patients hospitalized due to COVID-19. SARS-CoV-2-specific monoclonal antibodies, such as sotrovimab, may be associated with worse clinical outcomes when administered to hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation.

If a patient is hospitalized for reasons other than COVID-19 (e.g., an elective orthopedic procedure) and reports mild to moderate symptoms of COVID-19, confirmed with positive results of a direct SARS-CoV-2 viral test, FDA states that treatment with sotrovimab may be appropriate if the patient is also at high risk for progression to severe COVID-19 and the terms and conditions of the EUA are met.

Sotrovimab is not authorized under the EUA for prevention of COVID-19^{† [off-label]}.

The EUA for sotrovimab authorizes that distribution of the drug will be controlled by the US government for use consistent with the terms and conditions of the EUA. (See Restricted Distribution under Preparations.)

To mitigate risks of this unapproved drug, the EUA includes certain mandatory requirements (including providing information to the patient or parent/caregiver and ensuring that all medication errors and serious adverse events potentially attributable to sotrovimab are reported to FDA). (See EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting under Cautions.) In addition, the manufacturer is required to establish a process for monitoring genomic databases for emergence of global viral variants of SARS-CoV-2 and, if requested by FDA, must assess activity of sotrovimab against any global SARS-CoV-2 variants of interest.

Consult the sotrovimab EUA letter of authorization ([Web]), EUA fact sheet for health care providers ([Web]), and EUA fact sheet for patients, parents, and caregivers ([Web]) for additional information.

In nonhospitalized patients who require treatment for mild to moderate COVID-19, the NIH COVID-19 Treatment Guidelines Panel states that when logistical or supply constraints limit availability of SARS-CoV-2-specific monoclonal antibodies or oral antiviral agents because of high prevalence of the B.1.1.529 (Omicron) variant of concern (VOC), these drugs should be prioritized for patients who are at the highest risk of progressing to severe COVID-19. The Panel favors the use of ritonavir-boosted nirmatrelvir in most high-risk, outpatients with mild to moderate COVID-19. If ritonavir-boosted nirmatrelvir is unavailable or cannot be used because of drug interactions, the Panel recommends using sotrovimab in patients who live in areas with a high prevalence of the Omicron VOC. If sotrovimab is unavailable, the Panel recommends using a 3-day course of remdesivir. Molnupiravir should only be administered when ritonavir-boosted nirmatrelvir, sotrovimab, and remdesivir are either not available or cannot be used.

Sotrovimab Dosage and Administration

General

• Circulating SARS-CoV-2 viral variants may be associated with reduced susceptibility to SARS-CoV-2-specific monoclonal antibodies (see Actions and Spectrum); consider prevalence of SARS-COV-2 variants in the local area, if available, when choosing treatment options. Information on SARS-CoV-2 viral variants circulating in the US collected through CDC's national genomic surveillance program is available at [Web] and may help guide treatment decisions.

• Must be administered to outpatients in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS) as necessary.

• Must clinically monitor patient during IV infusion of sotrovimab and observe patient for at least 1 hour after completion of the infusion. (See Sensitivity and Infusion-related Reactions under Cautions.)

• Advise patients treated with sotrovimab to continue to self-isolate and use infection control measures (e.g., wear mask, isolate, socially distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, wash hands frequently) according to CDC guidelines.

Administration

IV Administration

Administer only by IV infusion.

For solution and drug compatibility information, see Compatibility under Stability.

Do not administer simultaneously through same IV infusion line with other drugs.

After IV infusion is completed, flush infusion line with 0.9% sodium chloride or 5% dextrose injection to ensure delivery of entire dose.

Dilution

Sotrovimab is supplied as a solution concentrate in single-dose vials; must dilute in 0.9% sodium chloride or 5% dextrose injection prior to IV infusion.

Remove vial containing sotrovimab solution concentrate (500 mg per 8 mL) from refrigerated storage (see Stability) and allow to equilibrate to room temperature for approximately 15 minutes while protecting from light.

Sotrovimab solution concentrate should appear as a clear, colorless or yellow to brown solution; discard if solution concentrate contains particulates or is discolored.

Prior to use, gently swirl vial several times without creating air bubbles; do not shake.

To prepare diluted sotrovimab solution, withdraw 8 mL of sotrovimab solution concentrate from the vial and dilute in a 50- or 100-mL prefilled polyvinyl chloride (PVC) or polyolefin (PO) IV infusion bag containing 0.9% sodium chloride injection or a 50- or 100-mL prefilled PVC IV infusion bag containing 5% dextrose injection. Prior to infusion, gently rock the IV bag back and forth 3–5 times; do not invert the bag and avoid formation of air bubbles.

Administer sotrovimab solution immediately following dilution. If immediate administration not possible, may store diluted solution for up to 6 hours at room temperature (up to 25°C) or for up to 24 hours in a refrigerator (2–8°C), including transport and infusion time. If diluted solution was refrigerated, allow it to equilibrate to room temperature for approximately 15 minutes prior to administration.

Use a polyvinyl chloride (PVC) or polyolefin (PO) infusion set; a 0.2-µm polyethersulfone (PES) filter is strongly recommend when administering sotrovimab solution for IV infusion.

Sotrovimab contains no preservatives; discard any unused solution concentrate remaining in the vial and any unused diluted solution of the drug.

Rate of Administration

Administer diluted solutions by IV infusion over 15 minutes for a 50-mL infusion bag or 30 minutes for a 100-mL infusion bag. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care. Clinically monitor patients during the infusion and for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity.

Dosage

Pediatric Patients

Coronavirus Disease 2019† [off-label] (COVID-19)

Outpatients with Mild to Moderate Disease† [off-label]

IV

FDA EUA that permits use for treatment of mild to moderate COVID-19 (see Coronavirus Disease 2019 [COVID-19] under Uses) states that pediatric patients ≥12 years of age weighing ≥40 kg who are outpatients at high risk for progression to severe COVID-19 should receive 500 mg of sotrovimab administered as a single IV infusion. Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Adults

Coronavirus Disease 2019† (COVID-19)

Outpatients with Mild to Moderate Disease†

IV

FDA EUA that permits use for treatment of mild to moderate disease (see Coronavirus Disease 2019 [COVID-19] under Uses) states that adults who are outpatients at high risk for progression to severe COVID-19 should receive 500 mg of sotrovimab administered as a single IV infusion. Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Prescribing Limits

Pediatric Patients

Coronavirus Disease 2019† (COVID-19)

IV

Single dose.

Adults

Coronavirus Disease 2019† (COVID-19)

IV

Single dose.

Special Populations

Hepatic Impairment

Effect of hepatic impairment unknown.

Renal Impairment

Dosage adjustment not recommended.

Geriatric Patients

Dosage adjustment not recommended.

Cautions for Sotrovimab

Contraindications

• Contraindicated in patients with known hypersensitivity to any ingredient in the preparation. (See Sensitivity and Infusion-related Reactions under Cautions.)

Warnings/Precautions

Sensitivity and Infusion-related Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported with sotrovimab. Hypersensitivity reactions occurring >24 hours after IV infusion reported with SARS-CoV-2-specific monoclonal antibody therapy.

Anaphylaxis reported in a hospitalized patient receiving sotrovimab (not an FDA-authorized use). IV infusion was immediately discontinued and event resolved following treatment with epinephrine; event recurred within 2 hours and then improved following administration of another epinephrine dose and there were no additional reactions.

Infusion-related reactions occurring during and up to 24 hours after IV infusion of sotrovimab reported; such reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmias (e.g., 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 (e.g., pre-syncope, syncope), dizziness, and diaphoresis.

If signs and symptoms of anaphylaxis or other clinically important hypersensitivity reaction occur, immediately discontinue sotrovimab IV infusion and initiate appropriate medications and/or supportive care.

If an infusion-related reaction occurs, consider slowing or stopping sotrovimab IV infusion and initiate appropriate medications and/or supportive care.

Clinical Worsening after SARS-CoV-2-specific Monoclonal Antibody Administration

Clinical worsening of COVID-19, including signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmias (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, reported following administration of SARS-CoV-2-specific monoclonal antibody therapy; hospitalization required in some cases. Not known whether these events were related to the SARS-CoV-2-specific monoclonal antibody or occurred because of progression of COVID-19.

Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19

Not authorized for use under the EUA in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or are on chronic oxygen therapy due to an underlying non-COVID-19-related comorbidity and require an increase in baseline oxygen flow rate due to COVID-19.

Benefit not observed when used in patients hospitalized due to COVID-19. SARS-CoV-2-specific monoclonal antibodies, such as sotrovimab, may be associated with worse clinical outcomes when administered to hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation.

EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

Safety and efficacy not established. FDA issued an EUA that permits use of sotrovimab for treatment of mild to moderate COVID-19^† in certain adults and pediatric patients in an appropriate setting via IV infusion using the dosage recommended in the EUA. (see Coronavirus Disease 2019 [COVID-19] under Uses)

Only limited data available to date regarding adverse effects associated with use of sotrovimab. Serious and unexpected adverse events may occur that have not been previously reported with the drug.

Completion of FDA MedWatch forms to report all medication errors and all serious adverse events potentially related to sotrovimab is mandatory. Consult fact sheet for health care providers that is provided with the drug and available at FDA website for requirements and instructions regarding reporting of adverse reactions and medication errors.

Specific Populations

Pregnancy

Data insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Estimated background risk of major birth defects and miscarriage related to COVID-19 unknown.

Use during pregnancy only if potential benefit outweighs potential risk for the woman and fetus. If used in pregnant women, dosage adjustment not recommended. Advise patients of the availability of a pregnancy registry for sotrovimab.

NIH panel states do not withhold SARS-CoV-2-specific monoclonal antibody therapy from a pregnant woman who has a condition that poses a high risk for progression to severe COVID-19 if clinician thinks potential benefit of the drug outweighs potential risk.

Nonclinical reproductive toxicity studies not performed. In a cross-reactive binding assay using a protein array enriched for human embryofetal proteins, no off-target binding detected for sotrovimab. Since sotrovimab is an Fc-enhanced human IgG, it has potential for placental transfer from the pregnant woman to the developing fetus. Not known whether such potential placental transfer provides any treatment benefit or risk to the developing fetus.

Lactation

Not known whether sotrovimab is distributed into human or animal milk, has effects on breast-fed infant, or affects milk production.

Consider the developmental and health benefits of breast-feeding along with the mother’s clinical need for sotrovimab and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition. If used in breast-feeding women, dosage adjustment not recommended.

Women with COVID-19 who are breast-feeding should follow clinical guidelines to avoid exposing the infant to the virus.

Pediatric Use

The FDA EUA permits use of sotrovimab for treatment of mild to moderate COVID-19^† in certain pediatric patients ≥12 years of age weighing ≥40 kg (see Coronavirus Disease 2019 [COVID-19] under Uses).

Not authorized in pediatric patients <12 years of age or weighing <40 kg. Safety and efficacy not assessed in pediatric patients.

The EUA-recommended dosage is expected to result in serum exposures of the drug in patients ≥12 years of age weighing ≥40 kg that are comparable to those observed in adults (based on an allometric scaling approach accounting for age-associated effects of body weight on clearance and volume of distribution).

Geriatric Use

Data from an ongoing trial evaluating sotrovimab for treatment of mild to moderate COVID-19 in outpatients (NCT04545060; COMET-ICE) indicate that 20% of the 430 patients treated with sotrovimab were ≥65 years of age and 10% were ≥75 years of age.

Difference in pharmacokinetics of sotrovimab in geriatric patients compared with younger patients unknown.

Hepatic Impairment

Effect of hepatic impairment on pharmacokinetics of sotrovimab unknown.

Renal Impairment

Not expected to affect sotrovimab exposure; drug not eliminated by renal excretion.

Common Adverse Effects

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.

Drug Interactions

Not metabolized by CYP isoenzymes and not renally excreted; interactions unlikely if used concomitantly with drugs that are substrates, inducers, or inhibitors of CYP isoenzymes or with drugs that are renally excreted.

Specific Drugs

Sotrovimab Pharmacokinetics

Absorption

Plasma Concentrations

Based on noncompartmental analysis, mean peak plasma concentration following a single 1-hour IV infusion is 137 mcg/mL and mean concentration on day 29 is 34 mcg/mL.

Distribution

Not known whether sotrovimab is distributed into human or animal milk.

Elimination

Metabolism

Not metabolized by CYP isoenzymes. Degraded by proteolytic enzymes.

Elimination Route

Not eliminated by renal excretion.

Dialysis not expected to affect pharmacokinetics.

Half-life

Approximately 49 days.

Special Populations

Renal impairment: Not expected to affect sotrovimab exposure since monoclonal antibodies with molecular mass >69 kDa do not undergo renal elimination.

Effects of hepatic impairment, sex, race, body weight, or disease severity on pharmacokinetics of sotrovimab unknown.

Stability

Storage

Parenteral

Solution Concentrate for Injection, for IV Infusion

Single-dose vials containing solution concentrate: Refrigerate (2–8°C); store in original carton. Do not freeze, shake, or expose to light.

Diluted solution for IV infusion: If immediate administration not possible, may store for up to 6 hours at room temperature (up to 25°C) or for up to 24 hours in a refrigerator (2–8°C), including transportation and infusion time.

Compatibility

Parenteral

Solution Compatibility1

Actions and Spectrum

• Sotrovimab (IgG₁κ) is a SARS-CoV-2-specific recombinant human monoclonal antibody; produced in a Chinese hamster ovary (CHO) cell line.

• Binds to SARS-CoV-2 and inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes. The Fc domain of sotrovimab includes the amino acid substitutions M428L and N434S (LS modification), which the half-life of the antibody but do not affect wild-type Fc-mediated effector functions in cell culture. Does not compete with human angiotensin-converting enzyme 2 (ACE2) receptor binding.

• In an in vitro SARS-CoV-2 virus neutralization assay in Vero E6 cells, sotrovimab neutralized SARS-CoV-2 (USA WA1/2020 isolate) with an average 50% effective concentration (EC₅₀) of 0.67 nM (100.1 ng/mL) and an average 90% effective concentration (EC₉₀) of 1.2 nM (186.3 ng/mL).

• In a Syrian golden hamster model of SARS-CoV-2 infection, animals given a single intraperitoneal dose of sotrovimab 24 or 48 hours prior to intranasal inoculation with SARS-CoV-2 (USA-590 WA1/2020) had less body weight loss and lower total SARS-CoV-2 viral RNA load in lungs compared with animals given vehicle alone or control antibody.

• Protection was also observed in the Syrian golden hamster model using the SARS-CoV-2 B.1.351 (Beta, South Africa origin) variant. Significant reductions in total and replication competent virus were observed on day 4 post-infection following a single dose of sotrovimab given intraperitoneally (0.5, 2, 5, or 15 mg/kg) compared to isotype control antibody-treated animals.

• There is a potential risk of treatment failure due to development of viral variants resistant to sotrovimab.

• In cell culture selection assays using virus-like particles (VLP) pseudotyped with SARS-CoV-2 spike protein, an E340A amino acid substitution in the spike protein emerged resulting in >100-fold reduced susceptibility to sotrovimab. A pseudotyped VLP assessment in cell culture showed that epitope amino acid sequence polymorphisms P337H/L/R/T, E340A/K/G, and K356T conferred reduced susceptibility to sotrovimab as follows: E340K (>297-fold), P337R (>276-fold), P337L (180-fold), E340A (>100-fold), E340G (27-fold), P337H (7.5-fold), P337T (5.4-fold), and K356T (5.9-fold). Presence of the highly prevalent D614G variant, either alone or in combination, did not affect sotrovimab neutralization.

• Interim data from an ongoing clinical trial evaluating sotrovimab for treatment of mild to moderate COVID-19 in outpatients (NCT04545060; COMET-ICE) indicated that 8 patients who received sotrovimab had post-baseline epitope variants, including P337L/E340K, E340A, E340K, E340V, A344V, K356R, R346G, S359G, and C361T. Of the variants detected at baseline and post-baseline, the L335F, L335S, P337L, G339C, E340A, E340K, A344V, R346G, R346I, K356N, K356R, R357I, I358V, and S359G substitutions have been assessed phenotypically using a pseudotyped VLP system. Results indicated that P337L, E340A, and E340K substitutions confer reduced susceptibility to sotrovimab (>180-fold, >100-fold, and >297-fold change in EC₅₀, respectively); sotrovimab retained activity (<2-fold change in EC₅₀) against the other substitutions. The clinical impact of these variants not known.

• Microneutralization data using authentic SARS-CoV-2 variant virus indicate that sotrovimab retains activity (<5-fold reduction in susceptibility) against the B.1.1.7 variant (UK origin), B.1.351 variant (South Africa origin), P.1 variant (Brazil origin), India origin B.1.617.1 variant (0.9-fold change in EC₅₀ value), and India origin B.1.617.2 variant (0.4 -fold change in EC₅₀ value). In vitro neutralization assays indicate that activity of sotrovimab was retained against pseudotyped VLP expressing key spike protein substitutions of concern for the UK origin B.1.1.7 variant spike proteins (2.3-fold; H69-, V70-, Y144-, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H), South Africa origin B.1.351 variant spike proteins (0.6-fold; L18F, D80A, D215G, R246I, K417N, E484K, N501Y, D614G, A701V), Brazil origin P.1 variant spike proteins (0.35-fold; L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I, V1176F), California origin 20C variant spike proteins (0.7-fold; S13I, W152C, L452R, D614G), New York origin B.1.526 variant spike proteins (0.6-fold; L5F, T95I, D253G, E484K, D614G, A701V), and India origin B.1.617 variant spike proteins (0.7-fold; T95I, G142D, E154K, L452R, E484Q, D614G, P681R, Q1071H), India origin B.1.617.2 variant spike proteins (1-fold; T19R, G142D, E156G, F157-, R158-, L452R, T478K, D614G, P681R, D950N), India origin AY.1 variant spike proteins (1.1-fold; T19R, T95I, G142D, E156G, F157-, R158-, W258L, K417N, L452R, T478K, D614G, P681R, D950N), India origin AY.2 variant spike proteins (1.3-fold; T19R, V70F, G142D, E156G, F157-, R158-, A222V, K417N, L452R, T478K, D614G, P681R, D950N), Peru origin C.37 variant spike proteins (1.5-fold; G75V, T76I, del246-252, L452Q, F490S, T859N), Colombia origin B.1.621 variant spike proteins (1.3-fold; T95I, Y144T, Y145S, ins146N, R346K, E484K, N501Y, D614G, P681H, D950N), and South Africa origin B.1.1.529 variant spike proteins (2.7-fold; A67V, del69-70, T95I, G142D, del143-145, del211, L212I, ins214EPE, G339D, S371L, S373P, S375F, K417N, N440K, G446S, S477N, T478K, E484A, Q493R, G496S, Q498R, N501Y, Y505H, T547K, D614G, H655Y, N679K, P681H, N764K, D796Y, N856K, Q954H, N969K, L981F).

Advice to Patients

• The Fact Sheet for Patients, Parents, and Caregivers: Emergency Use Authorization (EUA) of Sotrovimab for the Treatment of Coronavirus Disease 2019 (COVID-19) must be provided to patients or parent/caregivers prior to administration of sotrovimab.

• Inform patients or parent/caregivers that FDA authorized the emergency use of sotrovimab, which is an investigational drug that has not received FDA approval, for use in certain adults and pediatric patients with mild to moderate COVID-19 who are outpatients at high risk for progressing to severe COVID-19, including hospitalization or death.

• Inform patients or parent/caregivers that they have the option to accept or refuse sotrovimab.

• Provide patients or parent/caregivers with information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.

• Inform patients or parent/caregivers about the significant known and potential risks and benefits of sotrovimab, and the extent to which such risks and benefits are unknown.

• Advise patients treated with sotrovimab that they should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, socially distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, wash hands frequently) according to CDC guidelines.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

Additional Information

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 advised that decisions regarding use of drugs 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 manufacturer’s labeling should be consulted for more detailed information. 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.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Sotrovimab is not commercially available. FDA issued an emergency use authorization (EUA) for sotrovimab that allows use of the drug for the treatment of mild to moderate COVID-19^† in certain adults and pediatric patients who are outpatients at high risk for progression to severe COVID-19, including hospitalization or death. Contact the manufacturer (GlaxoSmithKline) at 866-475-2684 for information on how to obtain sotrovimab for use under the EUA.

Reload page with references included

Medical Disclaimer