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.

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

Bamlanivimab and etesevimab 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.

Bamlanivimab and etesevimab 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.

Bamlanivimab and etesevimab 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.

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

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.

Bamlanivimab and etesevimab 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 bamlanivimab and etesevimab 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. Bamlanivimab and etesevimab are still being studied and all of the risks are not yet known.

Bamlanivimab and etesevimab 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 have ever had:

• a COVID-19 vaccine;

• any serious or chronic illness;

• any allergies; or

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

Bamlanivimab is given with etesevimab in a single dose and does not have a daily dosing schedule.

In a medical setting an overdose would be treated quickly.

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

Get emergency medical help if you have signs of an allergic reaction: hives, itching; 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 of bamlanivimab 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.

Other drugs may affect bamlanivimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.