Pronunciation: ET e SEV a mib

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

The FDA has authorized emergency use of etesevimab together with another medicine called bamlanivimab to treat people with COVID-19 who are not in a hospital or using supplemental oxygen.

Etesevimab has not been approved to treat coronavirus or COVID-19.

What is etesevimab?

Etesevimab is an experimental medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if etesevimab is safe and effective.

The US Food and Drug Administration (FDA) has authorized emergency use of etesevimab given together with another medicine called bamlanivimab to treat mild to moderate COVID-19. These medicines are for use only in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Etesevimab with bamlanivimab is for use only in people who test positive for COVID-19 and have a high risk of symptoms becoming severe enough to need treatment in a hospital.

The risk of COVID-19 symptoms becoming severe may be higher in people with:

  • a high body mass index (BMI) of 25 or higher;
  • chronic kidney disease;
  • diabetes;
  • a weak immune system (caused by disease or by using certain medicine);
  • a heart problem;
  • sickle cell disease;
  • a neurodevelopmental disorder such as cerebral palsy;
  • asthma or other chronic breathing disorder needing daily medication to control; or
  • a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

There also may be a higher risk of severe COVID-19 symptoms in adults who are:

  • 65 years of age or older; or
  • 55 years of age or older AND have heart disease, high blood pressure, or lung disease such as chronic obstructive pulmonary disease (COPD).

There also may be a higher risk of severe COVID-19 symptoms in children (12 and older weighing at least 88 lbs or 40 kg) who have a BMI at or above the 85th percentile for age and gender.

Etesevimab has not been approved to treat coronavirus or COVID-19. However, this medicine given together with bamlanivimab may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. Etesevimab with bamlanivimab is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

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

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

Tell your doctor if:

  • you have any allergy;
  • you have any serious or chronic disease; or
  • you are pregnant or breastfeeding.

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 etesevimab and bamlanivimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

How is etesevimab given?

Etesevimab and bamlanivimab are injected into a vein by healthcare provider.

These medicines are injected slowly over 21 to 70 minutes. You will be watched for a short time to make sure you do not have an allergic reaction.

Bamlanivimab with etesevimab is usually given as only one dose as soon as possible after you test positive for COVID-19, or within 10 days after the start of symptoms.

Being treated with etesevimab and bamlanivimab 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.

These medicines also may not keep you from becoming infected with coronavirus again. Being treated with etesevimab and bamlanivimab could also affect your body's immune response to a coronavirus vaccine. Etesevimab and bamlanivimab are still being studied and all of the risks are not yet known.

What happens if I miss a dose?

Etesevimab is given with bamlanivimab in a single dose and does not have a daily dosing schedule.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving etesevimab?

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

What are the possible side effects of etesevimab?

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

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

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

Call your doctor if you have new or worsening symptoms after the infusion, such as fever, loss of taste or smell, confusion, tiredness, cough, trouble breathing, or chest pain.

Common side effects may include:

  • nausea;
  • dizziness; or
  • itching.

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 etesevimab?

Other drugs may affect etesevimab, 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 pharmacist can provide more information about etesevimab.

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