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bebtelovimab

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

The US Food and Drug Administration (FDA) has authorized emergency use of bebtelovimab for the treatment of mild-to-moderate COVID-19 in people 12 years of age and older (weighing at least 40 kg or 88 lbs).

Bebtelovimab have not been approved to treat coronavirus or COVID-19.

What is bebtelovimab?

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.

The US Food and Drug Administration (FDA) has authorized emergency use of bebtelovimab for the treatment of mild-to-moderate COVID-19 in people 12 years of age and older (weighing at least 40 kg or 88 lbs):

  • testing positive for COVID-19;
  • who are at high risk for progression to severe COVID-19, including hospitalization or death; and
  • for whom other COVID-19 treatment options are not available or applicable.

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.

Being treated with bebtelovimab will not make you less contagious to other people. Keep using infection control methods such as self-isolation, social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

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

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your bebtelovimab injection.

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?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregivers right away if you have:

  • 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.

Call your doctor if you have new or worsening symptoms after the injection, such as fever, confusion, weakness, tiredness, trouble breathing, or fast or slow heartbeats.

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.

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