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Casirivimab / Imdevimab Dosage

Medically reviewed by Drugs.com. Last updated on March 16, 2021.

Applies to the following strengths: 1332 mg/11.1 mL-1332 mg/11.1 mL; 300 mg/2.5 mL-300 mg/2.5 mL; 1332 mg/11.1 mL-300 mg/2.5 mL; 300 mg/2.5 mL-1132 mg/11.1 mL

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for COVID-19

For investigational use only

Casirivimab 1200 mg and imdevimab 1200 mg administered together as a single IV infusion (for a combined 2400 mg dose)

Comments:
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of the unapproved product, casirivimab with imdevimab (to be administered together), for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing at high risk for progressing to severe COVID-19 and/or hospitalization; this product is not approved by the US FDA for this use.
-The optimal dosing regimen has not been established for treatment of COVID-19; the recommended dosing regimen may be updated as clinical trial data become available.
-Casirivimab and imdevimab should be administered together as soon as possible after positive SARS-CoV-2 viral test and within 10 days of symptom onset.
-No dose adjustment recommended in pregnant or lactating patients.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing at high risk for progressing to severe COVID-19 and/or hospitalization

Usual Pediatric Dose for COVID-19

For investigational use only

12 years or older:
-At least 40 kg: Casirivimab 1200 mg and imdevimab 1200 mg administered together as a single IV infusion (for a combined 2400 mg dose)

Comments:
-The US FDA issued an EUA to allow the emergency use of the unapproved product, casirivimab with imdevimab (to be administered together), for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing at high risk for progressing to severe COVID-19 and/or hospitalization; this product is not approved by the US FDA for this use.
-The optimal dosing regimen has not been established for treatment of COVID-19; the recommended dosing regimen may be updated as clinical trial data become available.
-Casirivimab and imdevimab should be administered together as soon as possible after positive SARS-CoV-2 viral test and within 10 days of symptom onset.
-No dose adjustment recommended in pregnant or lactating patients.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing at high risk for progressing to severe COVID-19 and/or hospitalization

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
-This EUA is for the use of the unapproved product, casirivimab with imdevimab (to be administered together), to treat mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing at high risk for progressing to severe COVID-19 and/or hospitalization.
-Casirivimab and imdevimab must be administered together after dilution by IV infusion only (over at least 60 minutes); they may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction (e.g., anaphylaxis) and the ability to activate the emergency medical system, as needed.
-Healthcare providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS potentially related to this regimen; the Fact Sheet for Healthcare Providers should be consulted regarding reporting requirements.
-The authorized dosage may be updated as additional clinical trial data become available.
-ClinicalTrials.gov should be consulted for information on clinical trials testing this product in COVID-19.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years; casirivimab and imdevimab are not recommended for use in pediatric patients weighing less than 40 kg or those younger than 12 years.

Dialysis

Data not available

Other Comments

Administration advice:
-Casirivimab with imdevimab infusion solution should be administered by a qualified healthcare professional.
-Administer casirivimab and imdevimab together (after dilution) by IV infusion only; administer the entire infusion solution in the bag via pump or gravity over at least 60 minutes (maximum infusion rate: 250 mL/hour).
---Use a polyvinyl chloride (PVC), polyethylene (PE)-lined PVC, or polyurethane (PU) infusion set with an in-line or add-on 0.2-micron polyethersulfone (PES) filter.
---Due to potential overfill of prefilled saline bags, administer the entire infusion solution in the bag to avoid underdosage.
-Do not administer the prepared (diluted) infusion solution simultaneously with any other medication.
-After infusion is complete, flush the tubing with 0.9% Sodium Chloride Injection to ensure the required dose has been delivered.
-Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.

Storage requirements:
-Unopened vials: Store in refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze, shake, or expose to direct light.
---Remove casirivimab and imdevimab vials from refrigerated storage and allow to equilibrate to room temperature for about 20 minutes before preparation; do not expose to direct heat; do not shake the vials.
-Prepared (i.e., diluted) infusion solution: Should administer immediately; if immediate administration is not possible, store in refrigerator between 2C to 8C (36F to 46F) for no more than 36 hours or at room temperature up to 25C (77F) for no more than 4 hours. If refrigerated, allow to equilibrate to room temperature for about 30 minutes before administration.

Reconstitution/preparation techniques:
-Casirivimab with imdevimab solution for infusion should be prepared by a qualified healthcare professional.
-Casirivimab and imdevimab solutions must be diluted with 0.9% Sodium Chloride Injection before administration.
-The Fact Sheet for Health Care Providers should be consulted.

IV compatibility:
-Compatible: 0.9% Sodium Chloride Injection
-Compatibility with other IV solutions and medications is not known.

General:
-There are no adequate, approved, and available alternatives to casirivimab with imdevimab (administered together) for patients with mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization.
-Limitations of Authorized Use:
---This product is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
---Benefit of therapy with this product has not been seen in patients hospitalized due to COVID-19; monoclonal antibodies (such as casirivimab and imdevimab) may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.
-High-risk patients include those with at least 1 of the following criteria:
---Have BMI at least 35
---Have chronic kidney disease
---Have diabetes
---Have immunosuppressive disease
---Are currently receiving immunosuppressive therapy
---Are at least 65 years of age
---Are at least 55 years of age AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease
---Are 12 to 17 years of age AND have BMI greater than or equal to the 85th percentile for their age and gender based on US CDC growth charts, OR sickle cell disease, OR congenital/acquired heart disease, OR neurodevelopmental disorders (e.g., cerebral palsy), OR a medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19]), OR asthma, reactive airway disease, or other chronic respiratory disease that requires daily medication for control.

Patient advice:
-Read the Fact Sheet for Patients, Parents, and Caregivers.
-Continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, frequent handwashing) according to US CDC guidelines.

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