Generic Name: etesevimab (ET e SEV a mib)
Dosage Forms: intravenous solution (700 mg/20 mL)
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 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 or with supplemental oxygen.
The risk of COVID-19 symptoms becoming severe may be higher in people with:
a body mass index (BMI) of 35 or higher;
a weak immune system (caused by disease or by using certain medicine).
There also may be a higher risk of severe COVID-19 symptoms in adults who are:
65 years of age or older; or
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;
sickle cell disease;
a heart problem;
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).
Etesevimab has not been approved to treat coronavirus or COVID-19. However, etesevimab 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.
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.
Before taking this medicine
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 etesevimab is likely to be less harmful than not treating COVID-19 during pregnancy.
How is etesevimab given?
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.
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?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid after receiving etesevimab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Etesevimab side effects
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:
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 your current medicines and any medicine you start or stop using.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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