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Monoclonal Antibodies

Casirivimab 600 mg and Imdevimab 600 mg concentrate for solution for infusion.

Casirivimab and Imdevimab are human immunoglobulin G-1 (IgG1) monoclonal antibodies produced by recombinant DNA technology in Chinese hamster ovary cells. These antibodies are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus attachment and entry into human cells.

There are two distinct antibodies which bind non-competitively to the COVID-19 virus cell surface and prevents virus from infecting healthy cells.Using two antibodies protects against emergence of resistance.

Indications :

Casirivimab and Imdevimab are indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with laboratory confirmed SARS-COV2 infection and who are at high risk of severe COVID-19

High-risk is defined as patients who meet at least one of the following criteria

  • Body mass index (BMI) ≥35
  • Chronic kidney disease (eGFR<45 )
  • Diabetes, HbA1c >7.5
  • Immunosuppressive disease
  • Currently receiving immunosuppressive treatment
  • Age ≥65 years of age
  • Are ≥55 years of age and have cardiovascular disease/ hypertension/chronic obstructive pulmonary disease/other chronic respiratory disease

Age 12 – 17 years and have BMI ≥85th percentile for their age and gender based on CDC growth charts , sickle cell disease, or congenital or acquired heart disease, neurodevelopmental disorders (e.g., cerebral palsy), medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

Dosage :

  • The dosage in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is 600 mg of casirivimab and 600 mg of Imdevimab administered together as a single intravenous infusion.
  • Casirivimab and Imdevimab solutions must be diluted prior to administration.
  • Diluted with 250 mL of 0.9% Sodium Chloride Injection.
  • Infusion period is over 1 hour.

Efficacy :

As per trials – (Phase 3 : REGN10933 and REGN10987 (Casirivimab Plus Imdevimab) Versus Placebo in Outpatients with COVID-19 )

  • 70% relative risk reduction in COVID-19- related hospitalizations or all cause deaths in participants who received CAS 600 mg plus IMD 600 mg compared to those who received placebo.

Approval status :

  • U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) Casirivimab and Imdevimab in November 2020
  • Also been approved in countries such as Germany, Italy, France, Sweden, Hungary, Denmark, Netherland, Belgium, Iceland, Serbia, Czech Republic, Estonia, Brazil, Israel and India.

Safety Profile :

Hypersensitivity including Anaphylaxis and Infusion-Related Reactions

Infusion-related reactions have been observed with administration of casirivimab and imdevimab.Signs and symptoms of infusion related reactions may include:

  • fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.
  • Infusion-related reactions events were moderate in severity
  • One anaphylactic reaction was reported which resolved with medical treatment.