sotrovimab

Action and Spectrum

Actions and Spectrum: 

sotrovimab is a monoclonal antibody therapy that is used to treat COVID-19. It works by binding to a specific protein on the surface of the SARS-CoV-2 virus, called the spike protein, and preventing it from entering human cells. 

The action of sotrovimab is to neutralize the SARS-CoV-2 virus by blocking its ability to infect human cells. This can help to decrease the severity of COVID-19 symptoms and prevent the disease from progressing. 

sotrovimab is effective against several variants of the SARS-CoV-2 virus, including the B.1.1.7 (Alpha), B.1.351 (Beta), and P.1 (Gamma) variants. It has also effectively reduced hospitalization and death in patients with mild to moderate COVID-19 at high risk for severe disease. 

Overall, sotrovimab has a broad spectrum of activity against SARS-CoV-2 and can be an effective treatment option for COVID-19, particularly in high-risk patients. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Dizziness 

Hives 

Chest discomfort or pain 

Low or high blood pressure 

Weakness 

Shortness of breath 

Confusion 

Low oxygen level in the blood 

Nausea 

Fast or slow heart rate 

Fainting 

Rash 

Itching 

Wheezing 

Headache 

Muscle aches 

Sweating 

Chills 

Difficulty breathing 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

It is important to note that sotrovimab is only authorized for emergency use in patients with positive results of direct SARS-CoV-2 viral testing and only in individuals at high risk for progressing to severe COVID-19 or hospitalization. 

Additionally, sotrovimab should not be co-administered with other monoclonal antibody treatments for COVID-19, as this may reduce the effectiveness of the treatment. Patients should be monitored for signs of an allergic reaction or other adverse events during and after the administration of sotrovimab. 

It’s essential to consult with a healthcare professional or refer to the most up-to-date prescribing information for sotrovimab regarding any potential contraindications or precautions for using this medication. 

Caution 

There are a few important cautions to consider when administering sotrovimab, including the risk of clinical worsening and hypersensitivity reactions. 

Clinical worsening: sotrovimab is ineffective in treating hospitalized patients with COVID-19 or those requiring oxygen therapy due to COVID-19. Therefore, it is essential to monitor patients for signs of clinical worsening and to consider alternative treatments or hospitalization if symptoms worsen. 

Hypersensitivity reactions: Like other monoclonal antibody therapies, sotrovimab can potentially cause hypersensitivity reactions, including anaphylaxis. Patients should be monitored for signs, symptoms of hypersensitivity reactions during and after the administration of sotrovimab, and appropriate medical treatment should be available to manage any potential allergic reactions. 

Other cautions include the potential for interference with specific laboratory tests, as sotrovimab may interfere with some serological tests used to detect antibodies against SARS-CoV-2. It is recommended to use a different type of test to detect antibodies in patients who have received sotrovimab treatment. 

Pregnancy / Lactation

Pregnancy consideration:  

Pregnancy Category: N/A 

Lactation: N/A 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies do not show risk to the fetus in the first/later trimester.        
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women        
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.       
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.        
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.        
• Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

sotrovimab is a monoclonal antibody therapy that works by binding to a specific protein on the surface of the SARS-CoV-2 virus, called the spike protein. This binding blocks the ability of the virus to enter human cells, thereby neutralizing the virus and preventing it from causing further damage. 

sotrovimab is an IgG1 monoclonal antibody that is produced by recombinant DNA technology. It has a high affinity for the SARS-CoV-2 spike protein. It is effective against several variants of the virus, including the B.1.1.7 (Alpha), B.1.351 (Beta), and P.1 (Gamma) variants. 

Pharmacodynamics: 

Mechanism of action: This drug involves binding to conserved epitope on spike protein receptors binding domain of SARS-CoV-2. This recombinant human monoclonal antibody of IgG1-kappa has a dissociation constant KD of 0.21 nM, but it does not compete with the human ACE2 receptor binding (IC50 value more than 33.6 nM [5 mcg/mL]). Binding to the virus inhibits the undefined step that occurs after the virus attachment and before the fusion of viral and the cell membranes. 

Pharmacokinetics: 

Absorption 

sotrovimab is administered intravenously and is not subject to absorption from the gastrointestinal tract or other routes of administration. 

Distribution 

sotrovimab is distributed throughout the body via the bloodstream. It has a volume of distribution of approximately 5.6 L, indicating that it is primarily distributed in the extracellular fluid compartment. 

Metabolism 

Metabolism studies for sotrovimab have not been conducted, but as a monoclonal antibody, it is expected to be metabolized by proteolytic degradation and catabolism to small peptides and amino acids. 

Elimination and Excretion 

sotrovimab is primarily eliminated from the body through the reticuloendothelial system, which includes the liver and spleen. The elimination half-life of sotrovimab is approximately 23 days, which allows for sustained levels of the drug in the body and prolonged activity against the virus. 

Adminstartion

Administration: 

Intravenous administration 

sotrovimab is administered as an intravenous infusion in a healthcare setting under the supervision of a healthcare professional. The recommended dose of sotrovimab is 500 mg, given as a single infusion. 

The medication should be administered immediately after a positive test result for SARS-CoV-2 and within ten days of symptom onset. It is intended for high-risk individuals for progressing to severe COVID-19 or hospitalization. 

Before administration, patients should be screened for a history of allergic reactions to monoclonal antibodies or other components of sotrovimab. If an allergic reaction occurs during or after the infusion, the infusion should be stopped, and appropriate medical treatment should be administered. 

It’s essential to follow the specific dosing and administration instructions provided by the prescribing healthcare professional, as well as any local or national guidelines for using sotrovimab to treat COVID-19. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: sotrovimab 

Pronounced: [ soe-TROE-vi-mab ] 

Why do we use sotrovimab? 

sotrovimab is a monoclonal antibody therapy used for the treatment of COVID-19. It is specifically indicated for emergency use in patients with positive results of direct SARS-CoV-2 viral testing and at high risk for progressing to severe COVID-19 and hospitalization. 

sotrovimab is intended for use in individuals who are not currently hospitalized for COVID-19 but who are at high risk for progressing to severe diseases, such as those who have: 

• BMI of 35 or more 
• chronic kidney disease 
• diabetes 
• immunosuppressive disease 
• currently receiving immunosuppressive treatment 
• 65 years of age or older 
• 55 years of age or older AND have cardiovascular disease, hypertension, chronic obstructive pulmonary disease (COPD), or other chronic respiratory disease 

It’s important to note that sotrovimab is not a substitute for vaccination against COVID-19, and vaccination is still recommended for eligible individuals.