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FDA Emergency Use Authorizations allow healthcare providers to administer monoclonal antibodies:
The following frequently asked questions are for use with patients and individuals in the above two circumstances. FDA has also
granted an EUA for a monoclonal antibody for treatment of COVID-19 in hospitalized patients.
If you are high risk, develop mild to moderate symptoms, and test positive for COVID-19, early treatment with monoclonal antibodies may prevent progressing to more severe disease and hospitalization. If you do not have COVID-19 but are eligible for prophylactic treatment, monoclonal antibody treatment may prevent you from getting infected and becoming sick.
Monoclonal antibody treatments may help people who:Have mild to moderate symptoms of COVID-19, andHave tested positive for COVID-19, andHave had symptoms for 10 days or less, andAre at high risk of getting more serious symptomsMonoclonal antibody treatment may also help certain high-risk people avoid infection from being exposed to someone who has COVID-19. Eligible individuals who were in
close contact with an infected individual or who are at high risk of exposure to an individual infected with SARS-CoV-2,
AND are not
fully vaccinated or are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination You can learn more about treatment eligibility at
Monoclonal antibody treatments may help people who:
You can learn more about treatment eligibility at
Yes. Medicaid/CHIMonoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses like SARS-CoV-2. Monoclonal antibodies attack the virus and reduce its ability to spread through your body.P is
covering costs for infusion and injection administration.
I can refer you to receive treatment. The treatment is given by intravenous infusion where that is possible, or it will be given as a series of injections. If you receive an infusion, the infusion itself will take from about 15 minutes to an hour, and you will be at an infusion facility for two to three hours.
If you will receive injections, these can be administered from most any location by a trained professional. If you will receive an intravenous infusion, we can locate the nearest infusion site by using the information provided by the U.S. Department of Health and Human Services, which is
carefully tracking availability on their website. You can also reach them over the phone at 1-877-332-6585 (for English) or 1-877-366-0310 (for Spanish).
Some treatment-related side effects are possible. For those who receive an infusion, note that an infusion of any medicine may cause brief pain, bleeding, bruising of the skin, soreness, swelling, fever, chills, tiredness, nausea, headache, and possible infection at the infusion site. Hypersensitivity and allergic reactions may happen during and after an antibody infusion. Trained healthcare staff will monitor you for allergic reactions. While side effects are possible, antibody treatments do not contain any live virus. There is no risk you will get COVID-19 from monoclonal antibody treatments.
For post-exposure prophylactic outpatient use, data from a clinical trial showed that high-risk individuals who received monoclonal antibodies had an 81% risk reduction in the development of COVID-19 compared to individuals who did not receive monoclonal antibody treatment. Outpatient
data from clinical trials showed that high-risk COVID-19 patients treated with monoclonal antibodies had a 70% reduction in relative risk of progression to severe disease or hospitalization compared to patients who did not receive monoclonal antibodies. The treatment is most effective when given shortly after symptoms appear, so it is important to get tested and treated as soon as possible.
Yes. You must still follow isolation requirements to protect yourself and others.
Yes, but you should wait 90 days after treatment to get the vaccine.
Yes. Outpatients who develop COVID-19 infection despite vaccination may receive monoclonal antibody treatment.
Because the federal government has purchased a supply of some monoclonal antibody treatments, there may be no cost to the patient for the monoclonal antibody product itself. Depending on your insurance coverage, you may or may not need to pay for a provider to administer the infusion. For many, infusion administration will have no cost. In particular:Medicare, Medicaid, and Children's Health Insurance Program (CHIP) are
covering all infusion and injection administrative costs.
For patients covered under commercial insurance plans, costs of infusion may vary, but many large insurers are waiving all costs. Check with your health plan.
If you do not have insurance, you should ask the treatment facility if there are charges.
Because the federal government has purchased a supply of some monoclonal antibody treatments, there may be no cost to the patient for the monoclonal antibody product itself. Depending on your insurance coverage, you may or may not need to pay for a provider to administer the infusion. For many, infusion administration will have no cost. In particular:
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