bebtelovimab

What is the most important information I should know about bebtelovimab?

Due to the high frequency of the Omicron BQ.1 and BQ.1.1 sub-variants, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

What is bebtelovimab?

Due to the high frequency of the Omicron BQ.1 and BQ.1.1 sub-variants, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

Bebtelovimab is an experimental medicine being studied for the treatment of mild-to-moderate COVID-19. It is not yet known if this medicine is safe and effective.

Bebtelovimab is not authorized for use in people who:

• are likely to be infected with a variant of the virus that causes COVID-19 that will not be treated by bebtelovimab (ask your health care provider about the latest information on circulating variants by geographic area); or
• are hospitalized due to COVID-19; or
• need oxygen and/or respiratory support due to COVID-19; or
• need an increase in baseline oxygen and/or respiratory support due to COVID-19 and are on chronic oxygen treatment and/or respiratory support due to underlying non-COVID-19 related conditions.

Bebtelovimab is not a substitute for vaccination in people for whom COVID-19 vaccine is recommended. People who may benefit from COVID-19 vaccination should get vaccinated.

Bebtelovimab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving bebtelovimab?

Tell your doctor if you:

• have any allergies;
• are pregnant or plan to become pregnant;
• are breastfeeding or plan to breastfeed; or
• have any serious or chronic disease.

Bebtelovimab can weaken your immune system and may interfere with your body's ability to fight a future infection. Ask a healthcare provider about your individual risk.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but being treated with bebtelovimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

How is bebtelovimab given?

Bebtelovimab is injected into a vein by a healthcare provider over at least 30 seconds.

You will be watched for at least 1 hour to make sure you do not have an allergic reaction.

Bebtelovimab is still being studied and all the risks are not yet known.

What happens if I miss a dose?

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving bebtelovimab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of bebtelovimab?

• throat irritation, swelling in your face or throat;
• dizziness, a light-headed feeling (like you might pass out);
• chest pain, wheezing, shortness of breath;
• fever, chills, sweating, nausea;
• fast or slow heartbeats, headache, pounding in your neck or ears;
• weakness, tiredness;
• a rash or itching; or
• muscle pain.

Common side effects may include:

• infusion-related reactions such as confusion, trouble breathing, or fast or slow heartbeats;
• itching; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect bebtelovimab?

Other drugs may affect bebtelovimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about bebtelovimab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.01. Revision date: 12/2/2022.