etesevimab

Action and Spectrum

Actions and Spectrum: 

Monoclonal antibodies, which are the laboratory-produced proteins that generally mimic the immune system’s ability system to fight harmful pathogens, like viruses. They can be designed to target specific proteins/antigens found on the surface of the pathogen. These antibodies can help block viral entry into host cells, neutralize the virus, and trigger immune responses to eliminate the pathogen. 

The spectrum of action of a monoclonal antibody depends on its specific target. Some monoclonal antibodies have been developed to target viruses like SARS-CoV-2, which causes COVID-19. These antibodies can bind to the spike protein of the virus, averting it from attaching to host cells and reducing viral replication. Doing so could reduce the severity of the infection or prevent it altogether. 

Drug Interaction

Adverse Reaction

Pending

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

Some general contraindications and precautions associated with etesevimab: 

• Hypersensitivity: etesevimab should not be administered to individuals with a prior history of severe hypersensitivity reactions to etesevimab or its components. Hypersensitivity reactions may include rash, itching, difficulty breathing/swelling of the lips, face, tongue, or throat. 
• Co-administration with bamlanivimab: etesevimab is typically used with bamlanivimab to treat COVID-19. However, combination therapy should be avoided if an individual has a known hypersensitivity or severe allergic reaction to bamlanivimab. 
• Severe COVID-19: etesevimab is intended to treat mild to moderate COVID-19 cases in individuals at high risk of progressing to severe illness. It is not indicated for use in individuals with severe COVID-19 requiring hospitalization or oxygen therapy. 

Caution 

Specific cautions associated with etesevimab: 

• Use in Pregnancy and Breastfeeding: The safety and efficacy of etesevimab in pregnant or breastfeeding individuals have not been established. It is recommended to weigh the potential risks and benefits before using etesevimab in these populations. 
• Possible Interference with Serological Testing: etesevimab is a monoclonal antibody therapy that targets the spike protein of SARS-CoV-2, the virus that causes COVID-19. It is known that monoclonal antibodies like etesevimab can interfere with specific laboratory tests, including serological tests that detect antibodies. This interference may result in false-positive results in patients receiving etesevimab treatment. Therefore, it’s essential to consider the potential impact on test results and inform healthcare professionals about the current use of etesevimab before undergoing any diagnostic testing. 
• Resurgence of Viral Variants: Like other antiviral therapies, the emergence of new virus variants may impact the effectiveness of etesevimab. Monitoring the evolving situation and considering the prevalence of viral variants in the region is vital in determining the appropriateness of etesevimab treatment. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: N/A 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or 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: 

etesevimab is a monoclonal antibody that specifically targets the spike protein of SARS-CoV-2 virus, which is responsible for viral entry into human cells. The spike protein contains a receptor-binding domain (RBD) that interacts with the ACE2 receptor in human cells, allowing the virus to enter and also infect the cells. 

The pharmacology of etesevimab involves binding to the spike protein, specifically the RBD, thereby interfering with the interaction between the spike protein and the ACE2 receptor. This binding can prevent viral attachment and entry into host cells, neutralize the virus, and potentially reduce viral replication. 

By blocking the interaction between the spike protein and the ACE2 receptor, etesevimab aims to inhibit the initial stages of viral infection and spread within the body. It is intended for use in individuals diagnosed with COVID-19 and at high risk of progressing to severe disease or hospitalization. 

Pharmacodynamics: 

Mechanism of action: etesevimab is a monoclonal antibody that targets the spike proteins of the SARS-CoV-2 virus, which is responsible for viral entry into human cells. The mechanism of action of etesevimab involves binding to a particular region of the spike protein called the receptor-binding domain (RBD). 

When SARS-CoV-2 infects a person, the spike protein on the virus’s surface binds to the ACE2 receptor in human cells, facilitating viral entry and infection. etesevimab binds to the RBD of the spike protein and blocks its interaction with the ACE2 receptor. By doing so, etesevimab prevents viral attachment and entry into host cells. 

By neutralizing the spike protein, etesevimab aims to inhibit viral replication and reduce the severity of COVID-19 symptoms. This action is similar to other monoclonal antibodies developed to target the spike protein of SARS-CoV-2. 

Pharmacokinetics: 

Absorption 

Monoclonal antibodies are typically administered through intravenous infusion or subcutaneous injection. In these cases, absorption is irrelevant since the medication is delivered directly into the bloodstream. 

Distribution 

Monoclonal antibodies generally have a large volume of distribution, which means they can distribute throughout the body’s tissues and fluids. Distribution can be influenced by factors such as vascular permeability and target antigen expression. 

Metabolism 

Monoclonal antibodies are primarily eliminated unchanged from the body and do not undergo significant metabolism like small molecule drugs. However, they can be degraded or catabolized by proteolytic enzymes in the body. 

Elimination and Excretion 

Monoclonal antibodies are eliminated from the body mainly through renal clearance. They are filtered by the kidneys and excreted in the urine. The exact elimination half-life and clearance rate can vary depending on the specific monoclonal antibody. 

Adminstartion

Administration: 

etesevimab is a monoclonal antibody therapy used to treat certain viral infections, particularly COVID-19. etesevimab is typically administered intravenously (IV) in a healthcare setting.

It is generally given as single dose in combination with another monoclonal antibody called bamlanivimab. This combination therapy is used to treat mild to moderate cases of COVID-19 in individuals at high risk of developing severe illness. 

The exact dosage and administration schedule may vary depending on the specific treatment protocol that healthcare authorities or your healthcare provider recommends. Although, it is key to follow the instructions provided by your healthcare team. 

It’s important to note that the administration of etesevimab or any other medication should always be done under the supervision of qualified physician. They will assess your condition, determine the appropriate treatment plan, and administer the medication safely and effectively. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: etesevimab 

Why do we use etesevimab? 

etesevimab is a specific monoclonal antibody that was developed for the treatment of COVID-19. It is designed to target the spike protein of the SARS-CoV-2 virus, as it is responsible for viral entry into human cells. By binding to the spike protein, etesevimab aims to neutralize the virus and potentially reduce the severity of COVID-19 symptoms.