Monoclonal Antibody Treatment: Frequently Asked Questions

• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
  
  
• Eli Lilly: Bamlanivimab for COVID-19
  
  
• Bamlanivimab Emergency Use Authorization (EUA) Letter of Authorization, November 10, 2020 (PDF)
  
  
• Fact Sheet for Health Care Providers: Emergency Use Authorization (EUA) of Bamlanivimab (PDF)
  
  
• Regeneron: Authorized for FDA Emergency Use only Casirivimab and Imdevimab
  
  
• Casirivimab and Imdevimab Emergency Use Authorization (EUA) Letter of Authorization, November 21, 2020 (PDF)
  
  
• Fact Sheet for Healthcare Providers: Emergency Use Authorization (EUA) of Casirivimab and Imdevimab (PDF)

Antibody treatment can be used by people with mild to moderate COVID-19 who:

• Test positive for SARS-CoV-2.
• Are within 10 days of the start of their symptoms.
• Are age 12 or older and weigh at least 88 pounds.
• Are at high risk of getting very sick from COVID-19 or of needing to be admitted to a hospital because of COVID-19.

For questions about whether you can and should get antibody treatment, call your doctor or health care provider. If you do not have a doctor or health care provider, call the Minnesota Department of Health (MDH) at 651-201-3920.

High risk for progressing to severe COVID-19 and/or hospitalization is defined as patients who meet at least one of the following criteria:

• Have a body mass index (BMI) greater than 35.
• Have chronic kidney disease.
• Have diabetes.
• Have immunosuppressive disease.
• Are currently receiving immunosuppressive treatment.
• Are 65 years of age or older.
• Are 55 years of age or older AND have one or more of the following:
  • Cardiovascular disease.
  • Hypertension.
  • Chronic obstructive pulmonary disease/other chronic respiratory disease.
• Are 12-17 years of age AND have one or more of the following:
  • Body mass index greater than 85th percentile for their age and gender, based on CDC: Clinical Growth Charts.
  • Sickle cell disease.
  • Congenital or acquired heart disease.
  • Neurodevelopmental disorders, for example, cerebral palsy.
  • A 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.

Screening Tool for Monoclonal Antibody Treatment (PDF)

We do not know yet if it is safe to use the antibody treatment while pregnant. Women who are pregnant or breastfeeding should talk with their doctor or other health care provider. There is no available data on the presence of lab-made antibodies in human or animal milk, the effects on breastfed infants, or the effects on milk production.

CDC: Considerations for Newborns and Breastfeeding

The treatment should not be used for patients who:

• Are hospitalized due to COVID-19.
• Need oxygen therapy due to COVID-19.
• Those on chronic oxygen therapy due to underlying conditions not related to COVID-19 who need to increase in their baseline oxygen due to COVID-19.

The antibody treatment may make these conditions worse.

This is not the only treatment for COVID-19. Other treatments include the antiviral drug remdesivir, plasma from people who have recovered from COVID-19, and steroids. Talk to your doctor or other health care provider about treatments that are right for you.

Clinical trials for bamlanivimab and for casirivimab/imdevimab have shown a decrease in hospitalizations and emergency room visits and a decrease in the amount of virus in an infected person's blood. Studies are still ongoing.

• New England Journal of Medicine: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

Clinical studies are ongoing to evaluate the usefulness and safety of antibody treatment. It is possible that not all risks are known yet. Because bamlanivimab and casirivimab/imdevimab are antibody treatments, they could get in the way of your body’s own immune response to future infections with SARS-CoV-2, the virus that causes COVID-19, or they could affect your immune response to a vaccine for COVID-19.

The most common reported side effects with bamlanivimab are nausea, diarrhea, dizziness, headache, itchiness, and vomiting. The most common reported side effects with casirivimab/imdevimab are nausea and vomiting, hyperglycemia, and pneumonia. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

In clinical trials of bamlanivimab and casirivimab/imdevimab involving nearly 3,000 people, two severe allergic reactions and five serious reactions related to the delivery of the treatment into the vein were reported. All reactions were treated and resolved.

• Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19) (PDF)
• Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of Casirivimab and Imdevimab for Coronavirus Disease 2019 (PDF)

Antibodies must be given into a vein by intravenous (IV) infusion. Antibodies may be administered only in settings where health care providers have immediate access to medications to treat any reactions and where emergency medical systems are available, if needed, and where an emergency medical system is available, if needed.

Talk to your doctor or other health care professional about whether you should get antibody treatment and where you can get it. Supply will not meet demand when treatment first becomes available. You can see what locations have received shipments through the National Infusion Center Association: COVID-19 Monoclonal Antibody Infusion Center Locator. Receiving a shipment does not mean a location is open to the public.

To get started, go to National Infusion Center Association: COVID-19 Monoclonal Antibody Infusion Center Locator. On the "I am a…" line, click the down arrow and choose who you are. Then, on the "Looking for…" line, click the down arrow and choose from the following answers (available answers change based on how you answer "I am a…"):

1. A first place to receive my infusions/injections.
2. A location for a patient to receive their infusion/injections for the first time.
3. A location for them to receive their first infusions/injections.

On the last line, "Because…," select the answer that says why the person who will get the infusion has been placed on a new infusion/injection. Click "continue." A new map will load. Patients, providers, or family and friends can enter in their city, state, or ZIP code. The filter box contains a drop-down list of "Medications Available" that will default to "Covid Antibody Therapy." Click "Search" to find locations near you.

A health care provider must prescribe monoclonal antibody infusions.

The federal government is distributing antibody supplies at no cost to patients, until the end of 2020. However, some hospitals may bill insurance companies to administer the drug. The state of Minnesota is working to ensure that any location that gives antibody treatments is considered in network and covered by insurance. More information on insurance coverage of antibody treatments can be found at CMS: Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF).

MDH is committed to ensuring health equity and to seeing that everyone has fair access. MDH and a subgroup of a multi-agency Minnesota COVID Ethics Collaborative have given hospitals guidance for deciding how to distribute antibody supplies fairly among eligible patients. See Interim Ethical Guidance for Monoclonal Antibody Treatment Administration (PDF).

Each of the state's eight health regions get a share of the state's antibody treatment supplies. Each health region in the state has several locations for antibody treatment, taking into account geographic and population needs. Within each region, supplies are divided based on the number of beds among participating facilities, and supply and demand.

The U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response is overseeing distribution of national supplies. How much of the antibody supply states and territories get each week is based on their percentage of the country's total number of confirmed COVID-19 patients and the total number of confirmed COVID-19 patients hospitalized during the previous seven days.

More information on the distribution of bamlanivimab, including the amounts allocated by jurisdiction, is available at HHS/ASPR: Bamlanivimab. More information on the distribution of casirvimab/imdevimab, including the amounts allocated by jurisdiction, is available at HHS/ASPR: Casirivimab/Imdevimab.

We do not yet know how effective vaccines are in someone who has previously received an antibody treatment for a COVID-19 infection, or whether the antibody treatment could interfere with your body's own immune response to a vaccine. Once you have had COVID-19, you are very unlikely to be reinfected for three months afterward. So, if you receive an antibody treatment, you should delay receiving a vaccine for three months as a precaution.

See CDC: Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.