Uses

Etesevimab is usually used in combination with bamlanivimab. The FDA is allowing the emergency use of the combination of bamlanivimab and etesevimab to treat COVID-19. It is used by people who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 10 days, and are not hospitalized. This combination product is also being allowed to be used in the US to help prevent COVID-19 infection in people who have a high risk for infection after exposure to someone infected with COVID-19. Some conditions that increase risk of infection after exposure include: not being fully vaccinated, having had close contact, or being at high risk of close contact due to your housing conditions (such as a nursing home or prison). To receive this combination product, you must also be at high risk for COVID-19 complications, such as due to older age, obesity, or ongoing medical conditions (such as lung, kidney or heart disease, diabetes). In Canada, the combination of bamlanivimab and etesevimab has not yet been authorized by Health Canada for interim use. Talk to your doctor about the risks and benefits of treatment with bamlanivimab and etesevimab.

Bamlanivimab and etesevimab are antibodies which, when given soon after infection, can neutralize the coronavirus and may prevent worsening of COVID-19 symptoms. More information about bamlanivimab and etesevimab is available from the FDA Fact Sheet for Patients, Parents and Caregivers for Emergency Use, or should be provided by the doctor from the Informed Consent Form for a study.

There is limited information about how safe and effective the combination of bamlanivimab and etesevimab is for treating COVID-19. Study results show that bamlanivimab and etesevimab may help people who have recently tested positive for coronavirus stay out of the hospital. This combination product is not for use by people who are hospitalized due to COVID-19, or who need supplemental oxygen or a ventilator due to COVID-19.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of bamlanivimab and etesevimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

How To Use

Etesevimab is usually used in combination with bamlanivimab. The combination of bamlanivimab and etesevimab is given one time by injection into a vein by a healthcare professional. It is infused over 16 to 70 minutes. For children, the dosage is based on their weight. A healthcare professional will observe you during your infusion and for at least another hour after your treatment in case you have serious side effects.

Tell your doctor if your condition does not improve or if it gets worse.

Side Effects

Pain, soreness, swelling, or bruising at the injection site may occur. If you notice any of these effects, tell your healthcare professional promptly.

An infusion reaction may occur while this product is being given, causing symptoms such as low or high blood pressure, dizziness, slow/fast/irregular heartbeat, chest pain, trouble breathing, fever, chills, nausea, headache, confusion, sweating, or muscle pain. Get medical help right away if you notice any of these symptoms. A slower rate of infusion may help to lessen the risk of this reaction.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

Information is limited and it is unknown at this time if bamlanivimab and etesevimab cause other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Precautions

Before using this medication, tell your doctor if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how bamlanivimab and etesevimab work, or how bamlanivimab and etesevimab may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing (physical distancing), washing hands, and not sharing personal items.

Tell your doctor if you are pregnant or think you are pregnant. The combination of bamlanivimab and etesevimab should be used during pregnancy only if the possible benefits are greater than the possible risks.

It is unknown if bamlanivimab and etesevimab pass into breast milk. The risks of breast-feeding while infected with COVID-19 and while using this product should be discussed with the doctor.

Drug Interactions

Drug interactions may change how medications work or increase the risk for serious side effects. Information is limited and it is unknown at this time if bamlanivimab and etesevimab have drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor. Do not start, stop or change the dosage of any medicine without your doctor's approval.

Overdose

Overdose information is not available at this time.

Notes

Not applicable.

Missed Dose

Not applicable.

Storage

Not applicable. This product is not stored at home.