Sotrovimab

Sotrovimab is a prescription medication used to treat mild-to-moderate Coronavirus disease 2019 (COVID-19).

Dosages of Sotrovimab:

Adult and pediatric dosage

Injectable solution

• 500mg/8 mL (62.5 mg/mL)

COVID-19 (EUA)

• Adults and pediatric patients aged 12 years or older who weighs 88 pounds (40 kg)
• 500 mg as a single IV infusion 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Sotrovimab include:

• brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site

Serious side effects of Sotrovimab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• fever, 
• low oxygen level in the blood, 
• chills, 
• tiredness, 
• fast or slow heart rate, 
• chest discomfort or pain, 
• weakness, 
• confusion, 
• nausea, 
• headache, 
• shortness of breath, 
• low or high blood pressure, 
• wheezing, 
• rash, 
• itching, 
• muscle aches, 
• dizziness, 
• fainting, and
• sweating

Rare side effects of Sotrovimab include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Sotrovimab severe interactions with other drugs are unknown.
• Sotrovimab serious interactions with other drugs are unknown. 
• Sotrovimab moderate interactions with other drugs are unknown.
• Sotrovimab minor interactions with other drugs are unknown.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sotrovimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sotrovimab?”

Cautions

Hypersensitivity

• Serious hypersensitivity reactions, including anaphylaxis, may occur
• Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with SARS-CoV-2 monoclonal antibodies under EUA
• If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care
• Infusion-related reactions were reported, including 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, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis

Clinical worsening after administration

• Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status
• Some of these events required hospitalization
• Unknown if these events were related to the monoclonal antibodies or were due to the progression of COVID-19

Severe COVID-19

• Treatment benefit not observed in patients hospitalized with COVID-19
• Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation
• Therefore, use is not authorized for use in patients
  • Who are hospitalized with COVID-19, OR
  • Who require oxygen therapy for COVID-19, OR
  • Who requires an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19–related comorbidity)

Viral variants

• Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies
• Prescribing clinicians should consider the prevalence of etesevimab resistant variants in their area
• Healthcare providers should review antiviral resistance information provided by state and local health departments
• Variant proportions circulating in the United States can be monitored at the CDC website
• Pseudotyped virus-like particle neutralization data of Sotrovimab (May 2021)
  • B.1.1.7 (UK origin): No change: less than 5-fold reduction in susceptibility
  • B.1.351 (South Africa origin): No change: less than 5-fold reduction in susceptibility
  • P.1 (Brazil origin): No change: less than 5-fold reduction in susceptibility
  • B.1.427/B.1.429 (California origin): No change: less than 5-fold reduction in susceptibility
  • B.1.526 (New York origin): No change: less than 5-fold reduction in susceptibility
• Authentic SARS-CoV-2 neutralization data of Sotrovimab (May 2021)
  • B.1.1.7 (UK origin): No change: less than 5-fold reduction in susceptibility
  • B.1.351 (South Africa origin): No change: less than 5-fold reduction in susceptibility
  • P.1 (Brazil origin): No change: less than 5-fold reduction in susceptibility

Drug interaction overview

• Not renally excreted or metabolized by CYP450 enzymes
• Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely

Pregnancy and Lactation

• Insufficient data to evaluate the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Use during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus
• No dosage adjustment recommended by the manufacturer
• Nonclinical reproductive toxicity studies have not been conducted
• Sotrovimab is an Fc-enhanced human IgG and may have the potential for placental transfer from mother to developing fetus
• Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production
• Maternal IgG is known to be present in human milk
• No dosage adjustment recommended by the manufacturer