FULL EUA PRESCRIBING INFORMATION FULL EUA PRESCRIBING INFORMATION: CONTENTS* 11.3 Pediatric Use 1 AUTHORIZED USE 11.4 Geriatric Use 2 DOSAGE AND ADMINISTRATION 11.5 Renal Impairment 2.1 Patient Selection 11.6 Hepatic Impairment 2.2 Dosage 11.7 Other Specific Populations 2.3 Dosage Adjustment in Specific Populations 12 OVERDOSAGE 2.4 Dose Preparation and Administration 13 DESCRIPTION 3 DOSAGE FORMS AND STRENGTHS 14 CLINICAL PHARMACOLOGY 4 CONTRAINDICATIONS 14.1 Mechanism of Action 5 WARNINGS AND PRECAUTIONS 14.2 Pharmacodynamics 5.1 Hypersensitivity Including Anaphylaxis and Infusion- 14.3 Pharmacokinetics Related Reactions 15 MICROBIOLOGY/RESISTANCE INFORMATION 5.2 Limitations of Benefit and Potential for Risk in Patients 16 NONCLINICAL TOXICOLOGY with Severe COVID-19 17 ANIMAL PHARMACOLOGIC AND EFFICACY DATA 6 OVERALL SAFETY SUMMARY 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA 6.1 Clinical Trials Experience FOR EUA 7 PATIENT MONITORING RECOMMENDATIONS 18.1 Mild to Moderate COVID-19 (BLAZE-1) 8 ADVERSE REACTIONS AND MEDICATION ERRORS 19 HOW SUPPLIED/STORAGE AND HANDLING REPORTING REQUIREMENTS AND INSTRUCTIONS 20 PATIENT COUNSELING INFORMATION 9 OTHER REPORTING REQUIREMENTS 21 CONTACT INFORMATION 10 DRUG INTERACTIONS * Sections or subsections omitted from the full prescribing 11 USE IN SPECIFIC POPULATIONS information are not listed. 11.1 Pregnancy 11.2 Lactation 1 AUTHORIZED USE Bamlanivimab is authorized for use under an EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. LIMITATIONS OF AUTHORIZED USE  Bamlanivimab is not authorized for use in patients: o who are hospitalized due to COVID-19, OR o who require oxygen therapy due to COVID-19, OR o who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.  Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation [see Warnings and Precautions (5.2)]. 2 DOSAGE AND ADMINISTRATION 2.1 Patient Selection Bamlanivimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adults and pediatric patients 12 9