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Sotrovimab - Dosage and Side Effects

Published on May 16, 2022   -  4 min read

Abstract

Sotrovimab is a neutralizing monoclonal antibody (nMAb) used in the treatment of COVID-19. Read the following article to know more.

Contents

What Is Sotrovimab?

Sotrovimab, a neutralizing monoclonal antibody (nMAb), will remain in the body for at least four weeks and help prevent reinfection with COVID-19 (Coronavirus disease 2019). nMAbs are synthetic proteins that function in the immune system similar to human antibodies. They are created by cloning an antibody that can bind to the virus's spike protein and neutralize it. As a result, they cling to the virus and prevent it from infiltrating the lungs and causing an infection. Suppose a person is eligible for COVID-19 treatment; in that case, he or she will usually be given neutralizing monoclonal antibodies (nMAbs) such as Sotrovimab as the first line of defense rather than antiviral medications. Sotrovimab is administered at a dose of 500 mg. It is administered as a single dose through a drip in the arm (infusion) for more than 30 minutes. The most common side effects are nausea, dizziness, and an itchy rash, redness, or warmth on the skin.

On May 27, 2021, as requested by GlaxoSmithKline, the FDA (Food and Drug Administration) granted an emergency use authorization for the unapproved medication, Sotrovimab, to treat mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older and weigh at least 40 kg with positive results of direct SARS-CoV-2 (severe acute respiratory syndrome Coronavirus 2) viral testing. This also includes individuals who are in the high-risk category.

Sotrovimab is no longer approved to treat COVID-19 in any United States (U.S.) region as of April 5, 2022, due to an increase in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. Because of the high frequency of the Omicron BA.2 subvariant and data indicating that Sotrovimab is unlikely to be effective, the distribution was halted in all U.S. regions.

When selecting appropriate treatment options for patients, health care providers are advised to use other approved or authorized products. The FDA continues to monitor BA.2 in the United States and will communicate with the public as needed.

Who Is Eligible to Receive Sotrovimab?

Most adults and children over the age of 12 and those who weigh at least 40 kg can be given Sotrovimab. Individuals may be eligible for Sotrovimab if they meet the following criteria:

People in the high-risk category may have:

Who Is Contraindicated for Sotrovimab?

Sotrovimab is not recommended for patients who have a history of anaphylaxis to Sotrovimab or any of its formulation's excipients.

What Is the Dosage of Sotrovimab?

Adults and pediatric patients (12 years and older, weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, should receive Sotrovimab as a single IV infusion as soon as possible after a positive viral test for SARS-CoV-2 and within seven days of symptom onset. Sotrovimab is available as a concentrated solution that must be diluted before being infused intravenously. For example, 500 mg Sotrovimab should be administered intravenously over 15 minutes for a 50 ml infusion bag or 30 minutes for a 100 ml infusion bag. Patients are usually monitored during the infusion and observed for at least one hour after the infusion is finished.

What Are the Side Effects of Sotrovimab?

The side effects of Sotrovimab are common in up to one out of every ten people. The most common side effects are mild allergic reactions (hypersensitivity), which can include feeling nauseous, dizziness, an itchy rash, redness, and warmth on the skin. These symptoms usually appear within the first 24 hours and subside on their own.

Can Sotrovimab Be Used in Pregnant, Lactating, and Pediatric Populations?

Conclusion:

Due to an increase in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant, Sotrovimab is no longer approved to treat COVID-19 in the United States. However, other drug therapies, such as Paxlovid (Nirmatrelvir), Veklury (Remdesivir), Lagevrio (Molnupiravir), and Bebtelovimab, are expected to be effective against the BA.2 sub-variant and are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk of severe disease, including hospitalization or death.

Frequently Asked Questions


1.

What Is the Effectiveness of Sotrovimab Against Omicron?

Sotrovimab is currently the only monoclonal antibody that is effective against the omicron variant.

2.

What Is Sotrovimab’s Mechanism of Action?

Sotrovimab treats coronavirus (COVID-19) by binding to a protein on the virus's surface known as the spike protein. This prevents the virus from entering your lungs and infecting you. This can also help the body fight the virus and heal faster.

3.

How Effective Is Sotrovimab?

If a person has mild or moderate COVID-19, Sotrovimab is very effective at lowering the risk of severe symptoms and may reduce the need for hospitalization.

4.

How Long Does Sotrovimab Remain in the Body?

Sotrovimab is given in 500 mg doses and will remain in the body for at least four weeks and assists in the prevention of COVID-19 reinfection.

5.

How Long Does It Take for the Effects of Sotrovimab to Become Apparent?

Sotrovimab works best when taken as soon as possible after a positive COVID-19 test and within five days of the onset of symptoms.

6.

What Are the Side Effects of Sotrovimab?

Some common side effects that may occur up to 24 hours after the injection include:

- Fever, chills, sweating, nausea, weakness, and exhaustion.

- Throat irritation and swelling.

- A fluctuating heart rate.

- Confusion.

- Dizziness and lightheadedness.

- Wheezing.

- Shortness of breath.

- Chest pain.

- A rash or itching.

- Muscle pain.

- Headache.

However, not all possible side effects of the drug have been identified yet.

7.

What Are the Side Effects of Sotrovimab During Pregnancy?

There is little data on the use of Sotrovimab during pregnancy. The effect on the baby is unknown because it is an antibody that is likely to cross the placenta. Similar antibodies, however, are given during pregnancy for various reasons and are completely safe.

8.

What Is the Difference Between Sotrovimab and Remdesivir?

Sotrovimab 500 mg I.V. (intravenous) is given as soon as possible as a single infusion, and within ten days, and Remdesivir 200 mg I.V. is given on day one, then 100 mg once daily on days two and three, and is administered within a week of the onset of symptoms.

9.

Can Sotrovimab Be Used as an Intramuscular Injection?

Intravenous Sotrovimab is currently approved for the treatment of mild-to-moderate COVID-19 in patients over the age of 12 and weighing at least 40 kg (88 pounds). The approval is limited to patients who are at high risk of developing severe COVID-19. According to the companies, data from the Phase 3 COMET-TAIL trial found that a 500-mg intramuscular injection of the monoclonal antibody was not inferior to an intravenous injection.

10.

Are Oral Antivirals and Sotrovimab Given to Adults With COVID-19?

The National Medical Stockpile has provided supplies of the oral antivirals and the single-dose intravenous Sotrovimab to state and territory governments for use in their COVID care arrangements for the management of non-hospitalized adults with mild to moderate COVID-19 who may be at increased risk of disease progression.

11.

What Are the Contraindications of Sotrovimab?

Sotrovimab is contraindicated in those who have a history of anaphylaxis to the drug or any of the excipients in the formulation. Sotrovimab has limited clinical data. Serious and unexpected adverse events associated with Sotrovimab use may occur.

Article Resources

Last reviewed at:
16 May 2022  -  4 min read

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