On January 24, 2022, FDA reissued the emergency use authorization (EUA) for bamlanivimab and etesevimab stating that the combination regimen is not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency. Given the prevalence of the Omicron variant in the United States, bamlanivimab and etesevimab is not recommended for use anywhere for mild to moderate disease at the present time.
Bamlanivimab and etesevimab injection is currently being studied for the treatment and prevention of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.
Only limited clinical trial information is available at this time to support the use of bamlanivimab and etesevimab injection for the treatment of COVID-19. More information is needed to know how well the combination of bamlanivimab and etesevimab work for the treatment and prevention of COVID-19 and the possible adverse events from it.
Bamlanivimab and etesevimab injection has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow certain non-hospitalized adults and children and in hospitalized or non-hospitalized children and infants less than 2 years of age who have mild to moderate COVID-19 symptoms to receive bamlanivimab and etesevimab injection.
Why is this medication prescribed?
Bamlanivimab and etesevimab injection is used in certain non-hospitalized adults, children, and infants including newborns, and who have certain medical conditions that make them at higher risk for developing severe COVID-19 symptoms, including hospitalization or death:
- to treat mild to moderate symptoms of COVID-19.
- to prevent COVID-19 in those who are not fully vaccinated against COVID-19 or who are vaccinated, but have a weakened immune system, or are taking a medication that affects the immune system and who have had close contact or are at high risk of close contact to someone who is infected with the SARS-CoV-2 virus (for example, nursing homes, prisons).
Bamlanivimab and etesevimab is also used to treat mild to moderate symptoms of COVID-19 in hospitalized children and infants less than 2 years of age, including newborns.
Bamlanivimab and etesevimab are in a class called monoclonal antibodies. These medications work by blocking the action of a certain natural substance in the body to stop the spread of the virus.
How should this medicine be used?
Bamlanivimab and etesevimab injection come as solutions (liquids) to be mixed together with additional liquid and then injected slowly into a vein by a doctor or nurse.
For the treatment of COVID-19, it is given together as a one-time dose as soon as possible after a positive test for COVID-19 and within 10 days after the start of COVID-19 infection symptoms such as a fever, cough, or shortness of breath.
For the prevention of COVID-19 after exposure to someone who is infected with the SARS-CoV-2 virus, bamlanivimab and etesevimab injection should be given as soon as possible after the exposure.
Bamlanivimab and etesevimab injection may cause serious or life-threatening reactions during and after the infusion. A doctor or nurse will monitor you carefully while you are receiving these medications and for at least 1 hour after you receive them. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after the infusion: fever, difficulty breathing, chills, fatigue, chest pain, chest discomfort, weakness, confusion, nausea, headache, shortness of breath, wheezing, throat irritation, rash, hives, itching, flushing, muscle pain or dizziness, especially when standing up, sweating, or swelling of the face, throat, tongue, lips, or eyes. Your doctor may need to slow down your infusion or stop your treatment if you experience any of these side effects.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving bamlanivimab and etesevimab injection,
- tell your doctor and pharmacist if you are allergic to bamlanivimab, etesevimab, any other medications, or any of the ingredients in bamlanivimab and etesevimab injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: immunosuppressive medications such as cyclosporine (Gengraf, Neoral, Sandimmune), prednisone, and tacrolimus (Astagraf, Envarsus, Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have received a COVID-19 vaccine or if you have or have ever had any medical conditions.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving bamlanivimab and etesevimab injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
Bamlanivimab and etesevimab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- bleeding, bruising, pain, soreness, or swelling at injection site
Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:
- fever, difficulty breathing, changes in heart rate, tiredness, weakness, or confusion
Bamlanivimab and etesevimab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving these medications.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Ask your pharmacist any questions you have about bamlanivimab and etesevimab injection.
You should continue to isolate as directed by your doctor and follow public health practices such as wearing a mask, social distancing, and frequent hand washing.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Treatment with bamlanivimab and etesevimab injection is not a substitute for receiving a COVID-19 vaccine. Talk to your healthcare provider about receiving a vaccine if you have not already been vaccinated to prevent COVID-19.
The American Society of Health-System Pharmacists, Inc. represents that this information about bamlanivimab and etesevimab was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that bamlanivimab and etesevimab are not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, are being investigated for and are currently available under, an FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 or prevention of COVID-19 in certain outpatients and hospitalized children and infants less than 2 years of age. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about bamlanivimab and etesevimab are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about bamlanivimab and etesevimab are not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.