Bamlanivimab Injection

On April 16, 2021, the US Food and Drug Administration canceled the Emergency Use Authorization (EUA) for bamlanivimab injection for use alone in the treatment of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. Because of the increase in variants of the SARS-CoV-2 virus that are resistant to using bamlanivimab alone, the FDA has decided that the benefits of using this medication are no longer supported. However, bamlanivimab injection in combination with etesevimab injection continues to be authorized under an EUA for the treatment of COVID-19.

Bamlanivimab injection is currently being studied for the treatment 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 for the treatment of COVID-19. More information is needed to know how well bamlanivimab works for the treatment of COVID-19 and the possible adverse events from it.

Bamlanivimab 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 12 years of age and older who have mild to moderate COVID-19 symptoms to receive bamlanivimab injection.

Talk to your doctor about the risks and benefits of receiving this medication.

Bamlanivimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. It is used in people who have certain medical conditions that make them at higher risk for developing severe COVID-19 symptoms or the need to be hospitalized from COVID-19 infection. Bamlanivimab is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body to stop the spread of the virus.

Bamlanivimab comes as a solution (liquid) to be mixed with liquid and injected slowly into a vein over 60 minutes by a doctor or nurse. It is given 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.

Bamlanivimab injection may cause serious or life-threatening reactions during and after the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication and for at least 1 hour after you receive it. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after the infusion: fever; chills; nausea; headache; shortness of breath; high or low blood pressure; slow or fast heartbeat; chest pain or discomfort; weakness; confusion; tiredness; wheezing; rash, hives, or itching; muscle aches or pain; dizziness; sweating; or swelling of the face, throat, tongue, or lips. 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving bamlanivimab,

• tell your doctor and pharmacist if you are allergic to bamlanivimab, any other medications, or any of the ingredients in bamlanivimab 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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 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, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Bamlanivimab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• bleeding, bruising, pain, soreness, or swelling at injection site

Some side effects can be serious. If you experience any of these symptoms or those in the HOW section, call your doctor immediately or get emergency medical treatment.

• fever
• difficulty breathing
• changes in heart rate
• tiredness or weakness
• confusion

Bamlanivimab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

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).

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about bamlanivimab injection.

You should continue to isolate as directed by your doctor and follow public health practices such as 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.

The American Society of Health-System Pharmacists, Inc. represents that this information about bamlanivimab was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that bamlanivimab is not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under, an FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in certain outpatients. 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 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 is 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.

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