Casirivimab and Imdevimab photo
Information about this drug is likely to change. Note that this page was last updated 22 November 2020 and may be rendered inaccurate as more data emerges. This EUA approval and process is very similar to bamlanivimab.
KEY POINTS
- Casirivimab (REGN10933) and imdevimab (REGN10987) are recombinant human IgG1 monoclonal antibodies that target the receptor binding domain of the spike protein of SARS-CoV-2, which can reduce viral replication
- Monoclonal antibodies are molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cells
- Is a form of passive immunity
- The ending of the name “vi” is for targeting viruses and “mab” stands for monoclonal antibody
- Casirivimab and imdevimab are given together, neither is FDA-approved for any indication either alone or in combination
- This medication is produced by Regeneron Pharmaceuticals and was given to U.S. President Donald Trump when he had COVID-19
- It may reduce the need for hospitalization or emergency department visit when given in accordance with EUA criteria. Clinical data are provided in the Fact Sheet.
- Was given Emergency Use Authorization (EUA) status from the FDA on 22 November 2020
- EUA covers use by healthcare providers in an outpatient settings to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization
- There is a long, broad list of criteria for what is considered “high risk”
- Use an “outpatient” infusion sites is likely to be challenging from an infection control standpoint and overall logistics standpoint
- Use later in disease may lead to worse outcomes, is recommended to give within 10 days of symptom onset
- Not authorized to be given to:
- Adults or pediatric patients who are hospitalized due to COVID-19
- Adults or pediatric patients who require oxygen therapy due to COVID-19
- Adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity
- EUA covers use by healthcare providers in an outpatient settings to treat mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization
- Dosage is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered together as a single 250 mL infusion diluted in 0.9% NS given over at least 60 minutes via pump or gravity
- Infusion should be followed by a 1 hour observation period to monitor for adverse drug reactions
- No dose adjustment for renal function, effect of hepatic dysfunction is unknown
- Casirivimab and imdevimab come in separate solutions that must be diluted prior to administration
- Unopened vials require storage under refrigeration
- Both products come in two vial sizes (2.5 mL and 11.1 mL)
- Final 250 mL solution for infusion should be used within 36 hours if refrigerated and within 4 hours if kept at room temperature, including infusion time
- Unopened vials require storage under refrigeration
- Adverse events may occur
- Beware infusion-related reactions (fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness)
- Beware anaphylaxis and allergic reactions, one was reported to occur in the trial
- Began within 1 hour of completing the infusion and required treatment with epinephrine
- Adverse events reported as Grade 3 or 4 in the clinical trial with these drugs were pneumonia, hyperglycemia, nausea and vomiting (2,400 mg casirivimab and imdevimab), intestinal obstruction and dyspnea (8,000 mg casirivimab and imdevimab)
- Adverse reactions are to be reported to FDA Medwatch & Regeneron Pharmaceuticals
- Patient must be provided with the “Fact Sheet for Patients, Parents and Caregivers” and be agreeable to the therapy
- Drug-drug interactions are suspected to be unlikely
RESOURCES
- Casirivimab and Imdevimab Fact Sheet for Healthcare Providers (Similar to a Package Insert)
- FDA FAQ Sheet for Casirivimab and Imdevimab
- FDA Release on Casirivimab and Imdevimab
- FDA Emergency Use Authorization Letter
- HHS PHE Website: Allocation of COVID-19 Products (anticipate more coming here soon)
- According to this article, the U.S. government secured 300,000 doses for $450 million ($1,500 per dose)
- Operation Warp Speed Playbook for Allocation and Distribution of COVID-19 Therapeutic Medications
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