Bebtelovimab Injection

IMPORTANT WARNING:

Bebtelovimab injection is currently being studied for the treatment of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Clinical trial information is available at this time to support the use of bebtelovimab for the treatment of COVID-19. More information is needed to know how well bebtelovimab works for the treatment of COVID-19 and the possible adverse events from it.

Bebtelovimab 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 bebtelovimab injection.

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

IMPORTANT NOTICE:

As of November 30, 2022, the FDA is no longer recommending use of bebtelovimab in any region in the United States due to the increasing circulation of COVID-19 variants that bebtelovimab is not effective against.

WHY is this medicine prescribed?

Bebtelovimab 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, including the need to be hospitalized from COVID-19 infection or death. Bebtelovimab is in a class called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body in order to stop the spread of the virus.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Bebtelovimab injection comes as a solution (liquid) to be given intravenously (into the vein) by a doctor or nurse over 30 seconds. It is given as a one-time dose as soon as possible after a positive test for COVID-19 and within 7 days after the start of COVID-19 infection symptoms such as a fever, cough, or shortness of breath.

Bebtelovimab 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 this medication 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving bebtelovimab,

• tell your doctor and pharmacist if you are allergic to bebtelovimab, any other medications, or any of the ingredients in bebtelovimab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what 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 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.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

Bebtelovimab 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
• itching
• red, itchy, swollen skin

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

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

Bebtelovimab may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about bebtelovimab 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.

The American Society of Health-System Pharmacists, Inc. represents that this information about bebtelovimab was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that bebtelovimab 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 bebtelovimab 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 sotrovimab 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.