Sotrovimab - Dosage and Side Effects

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.

Health care providers are advised to use other approved or authorized products when selecting appropriate treatment options for patients. 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:

• They are in the high-risk category.

• They have had a positive PCR (polymerase chain reaction) test within the last five days.

• They have experienced coronavirus symptoms in the last five days.

People in the high-risk category may have:

• Down syndrome.

• Sickle cell anemia.

• A rare neurological or brain disorder (such as multiple sclerosis, motor neuron disease, Huntington's disease, or myasthenia gravis).

• HIV (human immunodeficiency virus), also known as AIDS (acquired immunodeficiency syndrome).

• Specific types of cancer.

• Stage 4 or 5 chronic kidney disease (CKD).

• A severe liver disease (such as cirrhosis).

• Some autoimmune or inflammatory diseases (such as rheumatoid arthritis or inflammatory bowel disease).

• Those who received an organ transplant.

• Had certain types of chemotherapy in the previous year.

• A condition or treatment that increases susceptibility to infections.

• Had radiotherapy in the previous six months.

Who Is Contraindicated for Sotrovimab?

Sotrovimab is not recommended for patients with 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 independently.

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

• Pregnancy: Data on the usage of Sotrovimab in pregnant women is either nonexistent or sparse. There has not been any research on reproductive toxicity in animals. No off-target binding was identified in a cross-reactive binding assay using a protein array optimized for human embryo fetal proteins. Because Sotrovimab is a human immunoglobulin G (IgG), it has the potential to pass from the mother to the developing fetus through the placenta. The potential medical benefit or risk of Sotrovimab being transferred to a growing baby through the placenta is unknown. Only if the expected benefit to the mother outweighs the potential harm to the fetus, Sotrovimab may be used during pregnancy.

• Lactation: There is no information on Sotrovimab excretion in human milk. A risk to neonates and infants cannot be ruled out. Human IgGs have been discovered in breast milk. The benefits of breastfeeding for the kid and therapy for the mom must be considered when deciding whether to stop breastfeeding or stop taking Sotrovimab.

• Fertility: There have been no fertility tests carried out.

• Pediatric Population: Sotrovimab is not authorized for usage in children under the age of 12 or who weigh less than 40 kg. Sotrovimab's safety and effectiveness in children have yet to be determined. In individuals aged 12 to 18 years old who weigh at least 40 kg, the suggested dose regimen is likely to result in Sotrovimab serum exposures comparable to those seen in adults.

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.