etesevimab

Pronunciation: ET e SEV a mib

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

Due to the high frequency of the Omicron BA.2 sub-variant, 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 etesevimab?

Due to the high frequency of the Omicron BA.2 sub-variant, 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.

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.

Etesevimab and bamlanivimab are also for use in people who have been exposed to COVID-19 and:

  • are not fully vaccinated against COVID-19; or
  • are vaccinated but may not have built up enough immunity (because they have certain diseases or use certain medicines), and have been or may be exposed to people who are infected with COVID-19.

Etesevimab and bamlanivimab are for use in adults and children of all ages, including newborns.

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

  • are overweight;
  • have chronic kidney disease;
  • have diabetes;
  • have a weak immune system (caused by disease or by using certain medicine);
  • have sickle cell disease;
  • have a heart problem or high blood pressure;
  • have a neurodevelopmental disorder such as cerebral palsy;
  • have asthma or other chronic breathing disorder; or
  • have 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 pregnant women and in adults who are 65 and older.

Etesevimab and bamlanivimab are not approved to treat or prevent coronavirus or COVID-19. However, these medicines may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. Bamlanivimab with etesevimab 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?

Etesevimab and bamlanivimab are not authorized for use in states or territories where certain variants of COVID-19 may be resistant to these medicines. Tell your doctor where you've lived or traveled to in the past 2 weeks.

Tell your doctor if:

  • you had a COVID-19 vaccine;
  • 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 are exposed to or 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, and 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 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 infusion, such as fever, confusion, weakness, tiredness, trouble breathing, or fast or slow heartbeats.

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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