Casirivimab;ImdevimabSnapshot

Indication

• Treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years or older, weighing at least 40 kg) with confirmed SARS-CoV-2 infection and at high risk for developing severe disease

• High risk is defined as any of the following:

  • 60 years or older

  • Obesity

  • Cardiovascular disease (including hypertension)

  • Chronic lung disease (including asthma)

  • Diabetes mellitus (type 1 or 2)

  • Chronic renal disease (including those on dialysis)

  • Chronic hepatic disease

  • Immunosuppressed based on investigator’s assessment (e.g., cancer treatment, bone marrow or organ transplantation, immune deficiencies, HIV if poorly controlled, AIDS)

  • Sickle cell anemia

  • Thalassemia

  • Prolonged use of immune-weakening medications

Dosage (1)

1,200 mg (i.e., 600 mg casirivimab and 600 mg imdevimab) administered together as a single intravenous infusion or subcutaneously

Administration:

• May be administered as a single intravenous infusion or subcutaneously. Follow instructions provided with product. (1)(2)(3)(4)

• Casirivimab and imdevimab are each supplied in individual single-dose vials

• The product must be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) (1)

• Infusion-related reactions have been observed and may be severe or life-threatening

  • Signs include: fever, chills, nausea, headache, bronchospasms, dyspnea, reduced oxygen saturation, fatigue, arrhythmia exacerbation (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, hypotension, hypertension, angioedema, throat irritation, rash, urticaria, pruritus, myalgia, dizziness, and diaphoresis

  • Consider slowing/stopping the infusion and administering supportive care

• Serious hypersensitivity reactions, including anaphylaxis, have been observed

  • If a clinically significant reaction develops, immediately discontinue treatment and administer supportive care

• Pregnancy:

  • Only use during pregnancy if potential benefits outweigh potential risk

  • No adequate data regarding treatment of pregnant women

• Infusion-related reactions: abdominal pain, flushing, fever, chills, pruritus, urticaria.

• Hypersensitivity reactions: anaphylaxis

COVID-19 vaccines:

• Defer COVID-19 vaccination for at least 90 days as a precaution to avoid interference with vaccine-induced immune responses

• Conversely, use/timing of casirivimab; imdevimab should not be affected by prior vaccinations in patients who develop COVID-19 after receiving the vaccine

References:

1. Cipla. Press release statement: Roche receives Emergency Use Authorization in India for its investigational antibody cocktail (casirivimab and imdevimab) used in the treatment of COVID-19. Retrieved May 7, 2021. Available on the World Wide Web at: https://www.cipla.com/press-releases-statements/roche-receives-EUA-India-investigational-antibody-cocktail-casirivimab-Imdevimab-covid

2. Roche. Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81%. Retrieved May 7, 2021. Available on the World Wide Web at: https://www.roche.com/investors/updates/inv-update-2021-04-12.htm

3. Regeneron Pharmaceuticals. COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection. Retrieved May 7, 2021. Available on the World Wide Web at: https://clinicaltrials.gov/ct2/show/NCT04666441

4. Regeneron Pharmaceuticals. COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay. Retrieved May 7, 2021. Available on the World Wide Web at: https://clinicaltrials.gov/ct2/show/record/NCT04452318

5. Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of casirivimab and imdevimab. Retrieved March 19, 2021. Available on the World Wide Web at https://www.fda.gov/media/145611/download

6. COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 21, 2021. Available at on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/