COVID-19 Monoclonal Antibody Treatments
As of January 24th, 2022, the FDA revised authorization for two monoclonal antibody products, and the product REGEN-COV (which Alps Pharmacy has been authorized to administer at the community level) has been removed from the FDA's list of authorized products to administer to treat COVID-19 at this time.
Treatment for COVID-19
In November 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow the use of monoclonal antibodies (mAb) for the treatment of mild to moderate symptoms of COVID-19 in adults and pediatric patients for post-exposure prophylaxis (i.e. taking medication to help prevent illness after exposure).
In a clinical trial of patients with COVID-19, REGEN-COV (one of several mAb therapies) was shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
Patients who are not at high risk of developing severe COVID-19 symptoms or requiring hospitalization generally find relief using over-the-counter remedies such as acetaminophen or ibuprofen. Getting rest and drinking water to keep hydrated also help. To limit the spread of the virus, infected individuals should isolate themselves from others.
What are monoclonal Antibodies
mAb are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses. They are used to treat an existing SARS-CoV-2 infection and may help prevent progression of the disease that would otherwise require hospitalization.
mAb treatment for COVID-19 is an investigational medicine and not a substitute for getting vaccinated. The vaccine trains the body to recognize the virus to be able to fight a future infection, while mAb is used to combat a current infection. To note, protection from a COVID-19 vaccine lasts longer than treatment from mAb therapy. Where possible, it is preferable to get vaccinated rather than to contract COVID-19 and need mAb therapy.
The monoclonal antibody treatment that we provide is called REGEN-COV, which is made up of the drugs casirivimab and imdevimab. They are administered together via four subcutaneous injections. Please refer to the FDA's EUA for patients:
Who is eligible for monoclonal Antibody Treatment
To be eligible, individuals must meet all of the following criteria:
be 12 years or older;
weigh at least 88 lbs;
be at high risk for progressing to severe COVID-19 (see high risk list below);
have tested positive for COVID-19 or been exposed to a positive case;
be within 10 days of symptom onset (ideally as soon as possible after diagnosis, even if symptoms are not too bad); AND
not be receiving oxygen therapy.
High risk includes any of the following:
65 years or older;
Chronic kidney disease;
Heart or lung disease;
BMI of 25 or greater;
Sickle cell disease;
Neurodevelopmental disorders (for example, cerebral palsy);
Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19); OR
Other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19.
REGEN-COV is not approved for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy. Benefits of treatment have not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when given to patients with COVID-19 requiring oxygen ventilation.
If you have questions about whether mAb treatment is right for you, contact your physician or give us a call at 417-719-4510.
We offer mAb treatments by appointment. Please call to book.
Are there side effects?
There may be possible side effects associated with taking REGEN-COV, including worsening symptoms after treatment. It is unknown if the worsening of symptoms is due to treatment or the progression of COVID-19. See the EUA Fact Sheet for Patients (link above) for details about side effects.
What is the cost?
There is no cost to the patient as the U.S. Government pays for the REGEN-COV treatment. We take patients' insurance information to bill the administration of the medication if the patient has insurance coverage.
How long should I wait after mAb treatment before getting a COVID-19 vaccine?
Per the Centers for Disease Control and Prevention (CDC), COVID-19 vaccination should be deferred for at least 90 days after receiving monoclonal antibody infusion.
References and further information: