etesevimab

Generic Name: etesevimab

• What is etesevimab?
• What are the possible side effects of etesevimab?
• What is the most important information I should know about etesevimab?
• What should I discuss with my healthcare provider before receiving etesevimab?
• How is etesevimab given?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid after receiving etesevimab?
• What other drugs will affect etesevimab?
• Where can I get more information?

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

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

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.

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 if you feel weak, dizzy, confused, nauseated, light-headed, anxious, itchy, sweaty, feverish or chilled, short of breath, or have a headache, muscle pain, chest pain, fast or slow heartbeats, or swelling in your face.

Call your doctor at once if you have:

• pain, bruising, bleeding, swelling, or skin changes where the medicine was injected; or
• new or worsening symptoms--fever, weakness, tiredness, confusion, trouble breathing, fast or slow heart rate.

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.

Etesevimab has not been approved to treat coronavirus or COVID-19. It is not yet known if this medicine is an effective treatment for any condition.

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.

Tell your doctor if:

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

It is not known whether etesevimab will harm an unborn baby. But receiving this medicine is likely to be less harmful than not treating COVID-19 during pregnancy.

Etesevimab is given together with bamlanivimab as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at 21 to 60 minutes or longer to complete.

Etesevimab is usually given with bamlanivimab as only one dose. The injection should be given within 10 days of when you first started having symptoms of COVID-19, and as soon as possible after you have tested positive.

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

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.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Other drugs may affect etesevimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about etesevimab.

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