What is Monoclonal antibody Therapy?
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.
WHAT IS REGEN-COV (Casirivimab and Imdevimab)?
REGEN-COV (Casirivimab and Imdevimab) is a treatment option for people with Covid-19 that are at high risk to get very sick from severe COVID-19, including hospitalization or death.
HOW DO I QUALIFY FOR TREATMENT?
You must be at least 18 years of age and older and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization.
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MONOCLONAL ANTIBODY THERAPY Frequently Asked Questions
Q. What is Casirivimab and Imdevimab?
Casirivimab and imdevimab are investigational medicines used to treat mild to moderate symptoms of COVID-19 in non-hospitalized adults and adolescents 18 years of age and older, and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. Casirivimab and imdevimab are investigational because they are still being studied. There is limited information known about the safety and effectiveness of using casirivimab and imdevimab to treat people with COVID-19.
Q. What is this drug for?
REGEN-COV is a monoclonal antibody which is a treatment option for people with Covid-19 that includes the DELTA VARIANT who has mild to moderate coronavirus disease 2019 (COVID-19) for 10 days or less. Even though this medication is approved for use in patients 12 years old and above, we will be offering the treatment for patients 18 years old and older weighing at least 40 kg) with positive results of SARSCoV-2 viral testing, and who are at high risk to get very sick from severe COVID-19, including hospitalization or death.
Q. What are the symptoms of COVID-19?
The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to become worse.
Q. How do I report side effects with Casirivimab Imdevimab?
Tell your healthcare provider right away if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 or call 1-844- 734-6643.
Q. What should I tell my health care provider before I receive Casirivimab and Imdevimab?
Tell your healthcare provider about all of your medical conditions, including if you:
- Have any allergies
- Are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed
- Have any serious illnesses
- Are taking any medications (prescription, over-the-counter, vitamins, and herbal products)
Q. What if I am pregnant or breastfeeding?
GVHC is NOT providing Monoclonal Antibody Therapy at this time to those who are pregnant or breastfeeding. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
Q. How will I receive Casirivimab and Imdevimab?
- Casirivimab and imdevimab are two investigational medicines given together as a single intravenous infusion (through a vein) for at least 1 hour.
- You will receive one dose of casirivimab and imdevimab by intravenous infusion. WHAT ARE THE IMPORTANT POSSIBLE SIDE EFFECTS OF CASIRIVIMAB AND IMDEVIMAB? Possible side effects of casirivimab and imdevimab are:
- Allergic reactions. Allergic reactions can happen during and after infusion with casirivimab and imdevimab.
Tell your healthcare provider or nurse, or get medical help right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, low blood pressure, changes in your heartbeat, shortness of breath, wheezing, swelling of your lips, face, or throat, rash including hives, itching, headache, nausea, vomiting, sweating, muscle aches, dizziness and shivering. 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 casirivimab and imdevimab. Not a lot of people have been given casirivimab and imdevimab. Serious and unexpected side effects may happen. Casirivimab and imdevimab are still being studied so it is possible that all of the risks are not known at this time. It is possible that casirivimab and imdevimab could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, casirivimab and imdevimab may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.
Q. WHAT IS COVID-19?
COVID-19 is caused by a virus called a coronavirus. People can get COVID-19 through contact with another person who has the virus. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can occur and may cause some of your other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.
Q. What other treatment choices are there?
Like casirivimab and imdevimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19.
Go to https://www.covid19treatmentguidelines.nih.gov/ for information on other medicines used to treat people with COVID-19. It is your choice to be treated or not to be treated with casirivimab and imdevimab. Should you decide not to receive casirivimab and imdevimab or stop it at any time, it will not change your standard medical care.
Q. What is an Emergency Use Authorization (EUA)?
The United States FDA has made casirivimab and imdevimab available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Casirivimab and imdevimab have not undergone the same type of review as an FDA-approved or cleared product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for casirivimab and imdevimab is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).