Monoclonal Antibodies FAQs
Q. What are monoclonal antibodies?
A. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses and bacteria which can cause disease.
Q. How do monoclonal antibodies work?
A. Monoclonal antibodies prevent the coronavirus 2019 (COVID-19) from invading cells in the human body. Bamlanivimab, a monoclonal antibody developed by Eli Lilly and Company, an American pharmaceutical company, and a combination of casirivimab/imdevimab produced by Regeneron Pharmaceuticals, Inc., are monoclonal antibodies used to treat COVID-19.
Q. Where is this treatment available in Illinois?
A. Monoclonal antibody treatment is administered in health care settings such as hospitals and medical clinics. Due to the limited availability of bamlanivimab and casirivimab/imdevimab at this time, these treatments are allocated based on the number of positive COVID-19 cases and the rates of hospitalizations across Illinois.
Q. Who is eligible to receive this treatment in Illinois?
A. Individuals who have tested positive and are experiencing mild or moderate COVID-19 illness symptoms and are considered “high risk” for progressing to severe COVID-19.
Pediatric patients, 12 years of age or older weighing at least 40 kilograms (about 80 pounds), and adults including those 65 years or age or older with certain chronic medical conditions can be considered eligible to receive this treatment. Chronic medical conditions include, but are not limited to:
- Having a body mass index (BMI) greater than 35
- Chronic kidney disease
- Immunosuppressive disease
- Are currently receiving immunosuppressive treatment
Q. When should someone seek this treatment?
A. Individuals who meet high risk criteria and test positive should contact their primary care physician about a referral for antibody treatment within three days of a positive test result and no later than 10 days after symptom onset.
Q. What is remdesivir?
A. On October 22, 2020, the Food and Drug Administration formally approved the antiviral medicine remdesivir (sold under the brand-name Veklury) as the first drug deemed safe and effective to treat COVID-19 in hospitalized adult and pediatric patients (12 years of age and older and weighing at least 88 pounds). Clinical trials found it appeared to most benefit patients who were receiving supplemental oxygen and was shown to reduce the recovery time in some people. Remdesivir should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care.
Q. Who can be treated with remdesivir?
A. Remdesivir is approved for adults and certain pediatric patients, specifically pediatric patients (12 years of age and older and weighing at least 88 pounds), for the treatment of COVID-19 requiring hospitalization. While not FDA-approved, a May 1, 2020 Emergency Use Authorization by the FDA for remdesivir continues to allow remdesivir for emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized children weighing 8 pounds to 88 pounds or hospitalized children less than 12 years of age weighing at least 8 pounds. Clinical trials assessing the safety and efficacy of remdesivir in the pediatric patient population are ongoing.
Q: How is remdesivir administered?
A: The FDA says remdesivir should be given via daily intravenous infusions for five days in most patients or 10 days among those on ventilators or life support. Pediatric patients weighing less than 88 pounds should receive remdesivir by injection based on body-weight dosing.
Q. Are their side effects of remdesivir?
A: Possible side effects may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around the eyes, under the skin), rash, nausea, constipation, sweating, and shivering. The most common side effect is nausea.
Q: How does remdesivir work?
A: Remdesivir works by blocking the key enzymes SARS-CoV-2, the virus that causes COVID-19, needs to make more copies of itself, which stops the virus from multiplying.
Q. Can remdesivir be used to PREVENT COVID-19?
A. The safety and efficacy of remdesivir for the prevention of COVID-19 has not been established and it is not FDA-approved for this use.
Q: What led to FDA’s approval of remdesivir?
A: Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use. In considering approval, the FDA conducted a benefit-risk assessment based on rigorous scientific standards to ensure the product’s benefits outweigh its risks for the intended population. The approval of remdesivir was supported by FDA’s analysis of data from three randomized, controlled clinical trials that included patients with mild-to-severe COVID-19.