Casirivimab (original) (raw)

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Description

An antibody used in emergency cases to treat mild to moderate COVID-19.

Description

An antibody used in emergency cases to treat mild to moderate COVID-19.

DrugBank ID

DB15941

Type

Biotech

US Approved

NO

Other Approved

YES

Mechanism of Action

• Spike glycoprotein (SARS-CoV-2)
  Binder

Summary

Casirivimab is part of an investigational recombinant monoclonal antibody cocktail used to treat mild to moderate COVID-19.

Generic Name

Casirivimab

DrugBank Accession Number

DB15941

Background

Casirivimab is a monoclonal antibody combined with Imdevimab in Regeneron's antibody cocktail known as REGN-COV2 for the treatment of COVID-19.4 This drug is a combination of antibodies derived from humanized VelocImmune® mice in addition to blood samples from patients who have recovered from COVID-19.1 These antibodies have been formulated to bind to multiple locations on the SARS-COV-2 spike protein, preventing viral escape.2

On November 21 2020, the FDA authorized emergency approval of REGEN-COV2 to treat mild to moderate COVID-19 in patients aged 12 years and older. Casirivimab and imdevimab are investigational recombinant human IgG1 monoclonal antibodies that, at this time, are not officially approved by the FDA. They are reserved for Emergency Use Authorization (EUA) only.5 In November 2021, the same indication was approved by the EMA.9,8

Full safety and efficacy data are not yet available, and further evaluation of this investigational therapy will continue.4,6,7

Type

Biotech

Groups

Approved, Experimental

Biologic Classification

Protein Based Therapies
Monoclonal antibody (mAb)

Protein Chemical Formula

Not Available

Protein Average Weight

Not Available

Sequences

Not Available

Synonyms

• Casirivimab

External IDs

• REGN 10933
• REGN-10933
• REGN10933

Indication

According to the Emergency Use Authorization (EUA) by the FDA and EMA, indevimab is used only with casirivimab to prevent COVID-19 and treat mild to moderate COVID-19 from laboratory-confirmed SARS-CoV-2 infection in patients aged 12 years of age and older who weigh at least 40 kg. Treatment is reserved for patients who are at high risk for progressing to require hospitalization or severe COVID-19.5,10,8

This combination may only be administered by intravenous infusion in healthcare settings with immediate access to treatment for infusion reactions and anaphylaxis, and the ability to activate the emergency medical system (EMS), as required.4,10

Limitations of use

Imdevimab and casirivimab are not for use in patients currently hospitalized due to COVID-19, patients requiring oxygen therapy due to COVID-19, patients requiring increases in baseline oxygen flow rate from COVID-19, or patients on oxygen therapy for non-COVID-19 related morbidity.5,10

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Contraindications & Blackbox Warnings

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Pharmacodynamics

Casirivimab and imdevimab work to neutralize the spike protein of SARS-CoV-2.5 In a clinical trial, casirivimab and imdevimab, when given together, reduced COVID-19-related hospitalization or emergency room visits in patients diagnosed with COVID-19 who were at high risk for disease progression within 28 days after treatment. No benefit has been shown in patients already hospitalized due to COVID-19 receiving this combination.4

Mechanism of action

Casirivimab is a recombinant human IgG1 monoclonal antibody targeting the receptor binding domain of the spike protein of SARS-CoV-2; a protein playing an important role in viral attachment, fusion, and entry into the cell.3,6 Together with imdevimab, casirivimab neutralizes the spike protein of SARS-CoV-2.6

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects

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Toxicity

There is limited information on overdose. Up to 4000 mg, which is approximately seven times the recommended dose of the drug, was administered in clinical trials. There is no known specific antidote for casirivimab overdose so treatment of overdose should involve general supportive measures.8

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Food Interactions

Not Available

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Brand Name Prescription Products

Mixture Products

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Casirivimab	Casirivimab (1332 mg/11.1mL)	Injection, solution, concentrate	Intravenous	Regeneron Pharmaceuticals, Inc.	2020-11-21	Not applicable
Casirivimab	Casirivimab (300 mg/2.5mL)	Injection, solution, concentrate	Intravenous	Regeneron Pharmaceuticals, Inc.	2020-11-21	Not applicable
Casirivimab With Imdevimab	Casirivimab (300 mg/2.5mL) + Imdevimab (300 mg/2.5mL)	Injection, solution, concentrate; Kit	Intravenous	Regeneron Pharmaceuticals, Inc.	2021-02-07	Not applicable
Casirivimab With Imdevimab	Casirivimab (1332 mg/11.1mL) + Imdevimab (1332 mg/11.1mL)	Injection, solution, concentrate; Kit	Intravenous	Regeneron Pharmaceuticals, Inc.	2021-02-07	Not applicable
Regen-cov	Casirivimab (1332 mg/11.1mL) + Imdevimab (300 mg/2.5mL)	Injection	Intravenous	Regeneron Pharmaceuticals, Inc.	2021-02-07	Not applicable

ATC Codes

J06BD07 — Casirivimab and imdevimab

• J06BD — Antiviral monoclonal antibodies
• J06B — IMMUNOGLOBULINS
• J06 — IMMUNE SERA AND IMMUNOGLOBULINS
• J — ANTIINFECTIVES FOR SYSTEMIC USE

Drug Categories

• Amino Acids, Peptides, and Proteins
• Antibodies
• Antibodies, Monoclonal
• Antiinfectives for Systemic Use
• Antiviral monoclonal antibodies
• Approved Treatments for COVID-19
• Blood Proteins
• Globulins
• Immune Sera and Immunoglobulins
• Immunoglobulins
• Immunoproteins
• Proteins
• Serum Globulins

Chemical TaxonomyProvided by Classyfire

Description

Not Available

Kingdom

Organic Compounds

Super Class

Organic Acids

Class

Carboxylic Acids and Derivatives

Sub Class

Amino Acids, Peptides, and Analogues

Direct Parent

Peptides

Alternative Parents

Not Available

Substituents

Not Available

Molecular Framework

Not Available

External Descriptors

Not Available

Affected organisms

Not Available

UNII

J0FI6WE1QN

CAS number

2415933-42-3

Synthesis Reference

Hansen J, Baum A, Pascal KE, et al. Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science. 2020;369(6506):1010-1014. doi:10.1126/science.abd0827

General References

1. Hansen J, Baum A, Pascal KE, Russo V, Giordano S, Wloga E, Fulton BO, Yan Y, Koon K, Patel K, Chung KM, Hermann A, Ullman E, Cruz J, Rafique A, Huang T, Fairhurst J, Libertiny C, Malbec M, Lee WY, Welsh R, Farr G, Pennington S, Deshpande D, Cheng J, Watty A, Bouffard P, Babb R, Levenkova N, Chen C, Zhang B, Romero Hernandez A, Saotome K, Zhou Y, Franklin M, Sivapalasingam S, Lye DC, Weston S, Logue J, Haupt R, Frieman M, Chen G, Olson W, Murphy AJ, Stahl N, Yancopoulos GD, Kyratsous CA: Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail. Science. 2020 Aug 21;369(6506):1010-1014. doi: 10.1126/science.abd0827. Epub 2020 Jun 15. [Article]
2. Matthews DB: A cocktail of antibodies for COVID-19 therapy. Nat Rev Immunol. 2020 Oct;20(10):591. doi: 10.1038/s41577-020-00431-9. [Article]
3. Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L: Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19. [Article]
4. Regeneron: Casirivimab and imdevimab [Link]
5. FDA Letter: EUA for Regeneron's casirivimab and imdevimab [Link]
6. FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 [Link]
7. Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19 [Link]
8. EMA Summary of Product Characteristics: RONAPREVE (casirivimab and imdevimab) intravenous or subcutaneous injection [Link]
9. EMA COVID-19 News: EMA recommends authorisation of two monoclonal antibody medicines [Link]
10. FDA Fact Sheet: Regeneron EUA HCP Fact Sheet [Link]

External Links

RxNav

2465242

Wikipedia

Casirivimab/imdevimab

Clinical Trials

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Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Prices

Not Available

Patents

Not Available

State

Not Available

Experimental Properties

Not Available

Targets

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Kind

Protein

Organism

SARS-CoV-2

Pharmacological action

Yes

Actions

Binder

General Function

Spike protein S1 Attaches the virion to the cell membrane by interacting with host receptor, initiating the infection. The major receptor is host ACE2 (PubMed:32142651, PubMed:32155444, PubMed:33607086). When S2/S2' has been cleaved, binding to the receptor triggers direct fusion at the cell membrane (PubMed:34561887). When S2/S2' has not been cleaved, binding to the receptor results in internalization of the virus by endocytosis leading to fusion of the virion membrane with the host endosomal membrane (PubMed:32075877, PubMed:32221306). Alternatively, may use NRP1/NRP2 (PubMed:33082294, PubMed:33082293) and integrin as entry receptors (PubMed:35150743). The use of NRP1/NRP2 receptors may explain the tropism of the virus in human olfactory epithelial cells, which express these molecules at high levels but ACE2 at low levels (PubMed:33082293). The stalk domain of S contains three hinges, giving the head unexpected orientational freedom (PubMed:32817270).

Specific Function

host cell surface receptor binding

Gene Name

S

Uniprot ID

P0DTC2

Uniprot Name

Spike glycoprotein

Molecular Weight

141177.29 Da

References

1. Matthews DB: A cocktail of antibodies for COVID-19 therapy. Nat Rev Immunol. 2020 Oct;20(10):591. doi: 10.1038/s41577-020-00431-9. [Article]
2. Regeneron: Casirivimab and imdevimab [Link]

Drug created at November 25, 2020 18:42 / Updated at February 03, 2022 19:50