Casirivimab

CASIRIVIMAB

Manufacturer: Regeneron Pharmaceuticals, Inc.

Score: 147.0

Quick Summary

Casirivimab is a monoclonal antibody used for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19. It is also used for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19. The recommended dosage is 600 mg of casirivimab and 600 mg of imdevimab administered together as a single intravenous infusion or by subcutaneous injection. Casirivimab and imdevimab should be given together as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset. The most common adverse reactions include infusion-related reactions, injection site reactions, and hypersensitivity reactions.

Key Clinical Findings and Indications

Treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg)
Post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19

Important Safety Information

Warning

Casirivimab and imdevimab are 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

Contraindications

Previous severe hypersensitivity reactions, including anaphylaxis, to casirivimab and imdevimab

Adverse Reactions

Infusion-related reactions
Injection site reactions
Hypersensitivity reactions

Dosing Recommendations

General Guidance

No dosage adjustment is recommended in pregnant or lactating women, pediatric patients who weigh at least 40 kg and are older than 12 years of age, or patients with renal impairment

Treatment of COVID-19

Adult Dose

600 mg of casirivimab and 600 mg of imdevimab administered together as a single intravenous infusion or by subcutaneous injection

Pediatric Dose

600 mg of casirivimab and 600 mg of imdevimab administered together as a single intravenous infusion or by subcutaneous injection for pediatric patients (12 years of age and older weighing at least 40 kg)

Post-exposure prophylaxis of COVID-19

Adult Dose

600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous injection or together as a single intravenous infusion

Pediatric Dose

600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous injection or together as a single intravenous infusion for pediatric patients (12 years of age and older weighing at least 40 kg)

Special Population Considerations

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Casirivimab and imdevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus

Nursing Mothers

No data are available on the presence of casirivimab and imdevimab in human milk
The effects of casirivimab and imdevimab on the breastfed infant, or the effects of casirivimab and imdevimab on milk production, are not known

Pediatric Use

Casirivimab and imdevimab are not authorized for use in pediatric patients under 12 years of age or weighing less than 40 kg
The safety and effectiveness of casirivimab and imdevimab are being assessed in pediatric and adolescent patients in an ongoing clinical trial

Geriatric Use

Of the 4,567 subjects with SARS-CoV-2 infection randomized in Trial COV-2067, 14% were 65 years or older, and 4% were 75 years of age or older
The difference in pharmacokinetics of casirivimab and imdevimab in geriatric patients compared to younger patients is unknown