casirivimab/imdevimab (REGEN-COV)
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Indications
- outpatients with Covid-19 at risk* for hospitalization &/or severe disease[5]
- approved for post-exposure Covid-19 prophylaxis[4]
- reduces development of symptomatic Covid-19 among asymptomatic SARS-CoV2-PCR positive individuals living with an infected contact[7]
* reduces risk for hospitalization or death by ~70%.
* high risk criteria
- older age >= 65 years
- overweight (BMI > 25 kg/m2) or obesity
- pregnancy
- chronic kidney disease
- diabetes mellitus
- immunosupression
- cardiovascular disease (including congenital heart disease & hypertension)
- chronic lung disease
- sickle cell disease
- neurodevelopmental disorders (cerebral palsy), genetic syndrome, metabolic disorders,] severe congenital anomalies
- medically-related technological dependence (tracheostomy, gastrostomy, positive-pressure ventilation)
- ethnicity may also be a risk factor
Contraindications
- hospitalized patients
- patients who require oxygen therapy due to Covid-19
- patients on chronic oxygen therapy who require an increase in baseline oxygen flow due to Covid-19
- ineffective against Omicron variant of SARS-CoV2[8] (off market Jan 2022)
Dosage
- casirivimab: 600 mg IV infusion over 1 hour
- imdevimab: 600 mg IV infusion over 1 hour
- must be diluted & infused together using a single intravenous bag
- intravenous bag may be stored refrigerated for up to 36 hours or for up to 4 hours at room temperature
- subcutaneous administration is alternative if intravenous infusion is not feasible
- combination co-formulated in a single vial, but casirivimab & imdevimab also packaged & made available in various sizes & configurations
* dosage for adults & adolescents 12 years of age >= 40 kg
Storage
refrigeration, preservative free, discard vial within 4 hours of opening
Adverse effects
- allergic reactions
- may worsen clinical outcomes in hospitalized patients requiring high flow oxygen therapy or mechanical ventilation
- report adverse events to FDA MedWatch program[2]
- provide copy of FDA MedWatch report to Regeneron
More general terms
Additional terms
Components
References
- ↑ Regeneron. Important Prescribing Information
- ↑ 2.0 2.1 FDA MedWatch program http://www.fda.gov/medwatch/report.htm
- ↑ Regeneron medical.information@regeneron.com
Weinreich DM, Sivapalasingam S, Norton T et al REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):238-251. Epub 2020 Dec 17. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33332778 Free PMC article - ↑ 4.0 4.1 Walker M Monoclonal Antibody Cocktail Authorized for Post-COVID Exposure - REGEN-COV becomes first monoclonal antibody treatment with EUA following exposure alone. MedPage Today July 30, 2021 https://www.medpagetoday.com/infectiousdisease/covid19/93844
O'Brien MP, Forleo-Neto E, Musser BJ et al Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. N Engl J Med 2021. Aug 4 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34347950 https://www.nejm.org/doi/full/10.1056/NEJMoa2109682
O'Brien MP, Forleo-Neto E, Musser BJ Subcutaneous REGEN-COV Antibody Combination for Covid-19 Prevention.. medRxiv. 2021 Jun 17:2021.06.14.21258567. Preprint. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34159344 PMCID: PMC8219114 Free PMC article. - ↑ 5.0 5.1 Frellick M Drug Cocktail Significantly Reduced Severe COVID, Death in Outpatients. Medscape. September 30, 2021 https://www.medscape.com/viewarticle/960060
Weinreich DM, Sivapalasingam S, Norton T et al REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. N Engl J Med. 2021 Dec 2;385(23):e81 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34587383 Free PMC article. https://www.nejm.org/doi/full/10.1056/NEJMoa2108163 - ↑ Walker J Covid-19 Antibody Drugs Are Challenged by Omicron, Preliminary Testing Indicates. Regeneron said its antibody drug cocktail was found to lose effectiveness against the new variant. Wall Street Journal. November 30, 2021 https://www.wsj.com/articles/covid-19-antibody-drugs-are-challenged-by-omicron-preliminary-testing-indicates-11638270003
- ↑ 7.0 7.1 O'Brien MP, Forleo-Neto E, Sarkar N et al Effect of Subcutaneous Casirivimab and Imdevimab Antibody Combination vs Placebo on Development of Symptomatic COVID-19 in Early Asymptomatic SARS-CoV-2 Infection. A Randomized Clinical Trial. JAMA. Published online January 14, 2022. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35029629 https://jamanetwork.com/journals/jama/fullarticle/2788256
- ↑ 8.0 8.1 American Medical Association (AMA) AMA Morning Rounds. Jan 25, 2022