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The safety information below outlines important warnings related to the use of REGEN-COV. Please read these details carefully and speak with your healthcare provider if you have any questions or concerns.

• Worsening of COVID-19 Symptoms: After receiving REGEN-COV, some individuals may experience a worsening of COVID-19 symptoms. These can include fever, trouble breathing, fatigue, confusion, and irregular heart rate or rhythm. It is crucial to contact your healthcare provider or seek medical attention if you notice any of these symptoms, as they may necessitate hospitalization. It is currently unclear whether these symptoms are related to REGEN-COV or the progression of the COVID-19 virus.

• Use in Severe COVID-19 Cases: REGEN-COV is not recommended for patients with severe COVID-19, particularly those who are hospitalized and require assistance with breathing, such as through ventilators or high-flow oxygen. In such cases, REGEN-COV may not be effective and could potentially worsen health outcomes. Therefore, it is not authorized for use in patients hospitalized due to COVID-19 or those needing new or increased oxygen treatment as a result of their infection.

Please consult your healthcare provider for more information or if you have specific health concerns related to the use of REGEN-COV.

Common side effects:

• Reactions at the iv infusion site such as pain, swelling, bleeding, bruising, or infections
• Reactions at the injection site like redness, bruising, itchiness, or infections

Less common but important to monitor:

• Serious allergic reactions manifesting as rash, hives, dizziness, sweating, trouble breathing, changes in blood pressure or heart rate, chest pain, or swelling of the lips, face, tongue, or throat
• Worsening of covid-19 symptoms such as fever, trouble breathing, changes in heart rate, weakness, or confusion

Casirivimab is a monoclonal antibody used in combination with imdevimab to treat certain cases of COVID-19. As monoclonal antibodies, casirivimab and imdevimab are not metabolized by the liver's cytochrome P450 enzymes, nor are they excreted through the kidneys. This means they are unlikely to interact with medications that are processed by these pathways.

However, there is a potential interaction with rozanolixizumab, another monoclonal antibody. Rozanolixizumab may reduce the blood levels and effectiveness of casirivimab and imdevimab. If you're prescribed both, your doctor may need to adjust your treatment plan or monitor you more closely.

Additionally, casirivimab and imdevimab target the spike protein of the SARS-CoV-2 virus, which is also the target of COVID-19 vaccines. Receiving these antibodies may interfere with the development of an effective immune response to a COVID-19 vaccine. Therefore, it's recommended to wait at least 90 days after antibody treatment before getting vaccinated.

Always inform your healthcare provider about all medications and treatments you're receiving to ensure safe and effective care.