Monoclonal Antibody Therapy

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Monoclonal Antibody Therapy for COVID-19
What is monoclonal antibody therapy (mAb)?

Monoclonal antibody therapy is appropriate for high-risk people suffering from COVID-19 symptoms, as well as for people who have merely been exposed to the virus from close contact with another person. For those diagnosed with COVID-19 who have symptoms, the treatment involves a short outpatient infusion session and is approved for people over 12 who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. The therapy has proven, through research, to decrease hospitalizations. 

Who is considered high risk and eligible for monoclonal antibody treatment?

High risk includes any of the following characteristics:

  • 65 years of age or older
  • Overweight (body mass index over 25)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes (type 1 and type 2)
  • Weakened immune system
  • Currently receiving immunosuppressive treatment
  • Cardiovascular disease/hypertension
  • Chronic lung disease
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Medical-related technological dependence

 

Other medical conditions or factors such as race or ethnicity may also place individual patients at high risk for progressing to severe COVID-19.

 
Monoclonal antibody therapy should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Patients having started or completed COVID-19 vaccination will be assessed to determine the benefit of monoclonal antibody therapy. 

My doctor prescribed Paxlovid or Molnupiravir. Where can I fill the prescription?

For a list of locations where you can find publicly available COVID-19 antiviral medications, such as Paxlovid and Molnupiravir, please click here.

Can I get Evusheld at Houston Methodist?

Yes, but there are strict criteria. Please contact your doctor. In December, the FDA granted emergency use authorization for Evusheld, a new pre-exposure preventive monoclonal two-dose injection for immunocompromised patients at highest risk, including solid organ transplant recipients, bone marrow transplant recipients and cancer patients. Evusheld is effective for 6 months, compared to other monoclonal treatments that are effective for 2-3 months, and is only authorized for those who are not currently infected with COVID-19 and who have not recently been exposed to someone infected with COVID-19. Please note, monoclonal treatments are not a substitute for vaccination. Everyone, including immunocompromised patients, should get the vaccine. 

How do I get monoclonal antibody therapy?

Please call your physician or use Virtual Urgent Care for a referral. 

What is an Emergency Use Authorization (EUA)?

The United States FDA has made monoclonal antibody infusions and injections available under an emergency access mechanism called an EUA. An EUA means that the drugs have not undergone the same type of review as an FDA-approved product, because the FDA approval process takes a long time. COVID-19 is a national crisis, and we do not have the luxury of the years it takes to go through an FDA approval process. An EUA is a shorter, simpler review process that is not as thorough as the approval process. 

What if I am pregnant or breastfeeding?

There is limited data treating pregnant women or breastfeeding mothers. For a mother and unborn baby, the benefit of receiving infusions or PEP may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your health care provider. 

What are the possible side effects of COVID-19 monoclonal antibody therapy?

One possible side effect of monoclonal antibody therapy is an allergic reaction. Allergic reactions can happen during and after infusion with monoclonal antibody therapy. Tell your health care provider right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low blood pressure, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, and dizziness.

 

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. These are not all the possible side effects of COVID-19 monoclonal antibody therapy. Not a lot of people have been given COVID-19 monoclonal antibody therapy. Serious and unexpected side effects may happen. COVID-19 monoclonal antibody therapy is still being studied, so it is possible that all of the risks are not known at this time.

How do I report side effects (or medical issues)?

Tell your primary care physician right away if you have any medical issues that bother you or side effects that do not go away. 

I’m now feeling much better as a result of the infusion. Can I cut my isolation short and go back to work or resume activities as before?

You should continue to isolate per your doctor's orders or CDC guidelines. To remain in isolation means staying in your home, washing your hands, disinfecting commonly shared hard surfaces, and staying at least 6-feet apart from others. You can return to work after you have met all of the requirements to end isolation.

I feel better but my employer wants me to get a new COVID-19 test before coming back to work. Should I be retested?

It probably will not help you to be retested at this time. Studies show that many people who test positive will continue to test positive for up to three months. You should continue to isolate per your doctor's orders or CDC guidelines, after which you can return to work.

Can I receive the COVID-19 vaccine after having a monoclonal antibody infusion or injections

It is recommended that patients wait 90 days after receiving a COVID-19 monoclonal antibody treatment before starting or continuing a COVID-19 vaccine or vaccine series. The monoclonal antibody therapy is expected to provide a temporary immunity during this period of time.

How can I learn more?