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Monoclonal Antibody Treatment

Frequently Asked Questions

Antibodies are proteins that people’s bodies make to fight viruses, such as the virus that causes COVID-19. Antibodies made in a laboratory act a lot like natural antibodies to limit the amount of virus in your body. They are called monoclonal antibodies.

Monoclonal antibody treatment with bamlanivimab or with casirivimab and imdevimab are for people who have tested positive for COVID-19 and have mild to moderate symptoms. Casirivimab and imdevimab must be given together. Bamlanivimab is given alone. These treatments are allowed by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) while clinical studies continue to look at their usefulness and safety.

Monoclonal Antibody Treatment Sites

We currently have two sites available for monoclonal antibody treatment.

Frequently Asked Questions

Under section 564 of the Federal Food, Drug & Cosmetic Act, the FDA may, pursuant to a determination and declaration by the HHS Secretary, authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing an EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or lifethreatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential benefits outweigh the known and potential risks for the product; and that there are no adequate, approved, and available alternatives. Emergency use authorization is NOT the same as FDA approval or licensure.

Bamlanivimab is a monoclonal antibody. Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cells. Bamlanivimab is designed to block viral attachment and entry into human cells, thus neutralizing the virus. It is designed to limit viral replication and may be effective for the treatment of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

 

When administered to non-hospitalized patients as soon as possible after positive viral testing for SARSCoV-2 and within 10 days of symptom onset, bamlanivimab may reduce viral load, symptoms, and risk of hospitalizations and emergency room visits associated with COVID-19

Patient Eligibility

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 18 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, visit or call the California Department of Public Health (CDPH).

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.

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.

Benefits and side effects

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.

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

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.

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.

How to get treatment

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.

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.

Cost and insurance

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. More information on insurance coverage of antibody treatments can be found at CMS: Coverage of Monoclonal Antibody Products to Treat COVID-19 (PDF).

Distribution and equity

GVHC is committed to ensuring health equity and to seeing that everyone has fair access. 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.

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