Bamlanivimab (Page 3 of 12)

APPROVED AVAILABLE ALTERNATIVES

Veklury (remdesivir) is FDA-approved for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days.

Although Veklury is an approved alternative treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, FDA does not consider Veklury to be an adequate alternative to bamlanivimab and etesevimab for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires a 3-day treatment duration).6

There is no adequate, approved and available alternative to bamlanivimab and etesevimab administered together for post-exposure prophylaxis of COVID-19 in adult and pediatric individuals, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated 3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications 4) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
    • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].

Additional information on COVID-19 therapies can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html. The health care provider should visit https://clinicaltrials.gov/ to determine whether the patient may be eligible for enrollment in a clinical trial.


6
Additionally, the approval for Veklury does not cover certain pediatric patients for whom bamlanivimab and etesevimab administered together is authorized (e.g., patients less than 12 years of age).

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. FDA has issued this EUA, requested by Eli Lilly and Company for the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.5

FDA has also issued this EUA, requested by Eli Lilly and Company for the unapproved products bamlanivimab and etesevimab administered together in adults and pediatric individuals, including neonates, for post-exposure prophylaxis of COVID-19 in individuals who are at high risk of progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated 3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications 4) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
    • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that bamlanivimab and etesevimab administered together may be effective for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in individuals as specified in this Fact Sheet. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency.

This EUA for bamlanivimab and etesevimab will end when the Secretary determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

As a health care provider, you must comply with the mandatory requirements of the EUA (see above).

CONTACT INFORMATION
For additional information visit
www.LillyAntibody.com

If you have questions, please contact1-855-LillyC19 (1-855-545-5921)

END SHORT VERSION FACT SHEETLong Version Begins on Next Page

FULL EUA PRESCRIBING INFORMATION

FULL EUA PRESCRIBING INFORMATION: CONTENTS* 11.2 Lactation
1 AUTHORIZED USE 11.3 Pediatric Use
1.1 Treatment 11.4 Geriatric Use
1.2 Post-Exposure Prophylaxis 11.5 Renal Impairment
2 DOSAGE AND ADMINISTRATION 11.6 Hepatic Impairment
2.1 Patient Selection 11.7 Other Specific Populations
2.2 Dosage 12 OVERDOSAGE
2.3 Dosage Adjustment in Specific Populations 13 DESCRIPTION
2.4 Dose Preparation and Administration 14 CLINICAL PHARMACOLOGY
3 DOSAGE FORMS AND STRENGTHS 14.1 Mechanism of Action
4 CONTRAINDICATIONS 14.2 Pharmacodynamics
5 WARNINGS AND PRECAUTIONS 14.3 Pharmacokinetics
5.1 Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions 15 MICROBIOLOGY/RESISTANCE INFORMATION
5.2 Clinical Worsening After Bamlanivimab and Etesevimab Administration 16 NONCLINICAL TOXICOLOGY
5.3 Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19 17 ANIMAL PHARMACOLOGIC AND EFFICACY DATA
6 OVERALL SAFETY SUMMARY 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA
6.1 Clinical Trials Experience 18.1 Treatment of Mild to Moderate COVID-19 (BLAZE-1)
7 PATIENT MONITORING RECOMMENDATIONS 18.2 Post-Exposure Prophylaxis of COVID-19 (BLAZE-2)
8 ADVERSE REACTIONS AND MEDICATION ERRORS REPORTING REQUIREMENTS AND INSTRUCTIONS 19 HOW SUPPLIED/STORAGE AND HANDLING
9 OTHER REPORTING REQUIREMENTS 20 PATIENT COUNSELING INFORMATION
10 DRUG INTERACTIONS 21 CONTACT INFORMATION
11 USE IN SPECIFIC POPULATIONS * Sections or subsections omitted from the full prescribing information are not listed.
11.1 Pregnancy

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