bamlanivimab and etesevimab

Bamlanivimab and etesevimab are investigational medicines used to treat mild to moderate symptoms of COVID-19 in adults and adolescents (12 years of age or older who weigh at least 88 pounds [40 kg]), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization.

• Bamlanivimab and etesevimab have not been approved, but have been authorized for emergency use by the FDA
• Bamlanivimab and etesevimab are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Important possible side effects of bamlanivimab and etesevimab:

Allergic reactions. Allergic reactions can happen during and after infusion with bamlanivimab and etesevimab. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions:

• fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness, and sweating. These reactions may be severe or life threatening.

Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness, or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

These are not all the possible side effects of bamlanivimab and etesevimab. Not a lot of people have been given bamlanivimab and etesevimab. Serious and unexpected side effects may happen. Bamlanivimab and etesevimab are still being studied so it is possible that not all of the risks are known at this time.

It is possible that bamlanivimab and etesevimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bamlanivimab and etesevimab may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.

• Have any allergies
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Have any serious illnesses
• Are taking any medications (prescription, over-the-counter, vitamins, and/or herbal products)

There is limited experience treating pregnant women or breastfeeding mothers with bamlanivimab and etesevimab. For a mother and unborn baby, the benefit of receiving bamlanivimab and etesevimab may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

Read the Fact Sheet for Patients, Parents and Caregivers for more information about bamlanivimab and etesevimab.

BM ET CON ISI EUA 09FEB2021