bamlanivimab

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What is the criteria for use and recommended dose of bamlanivimab alone for the treatment of COVID-19?

The dose of bamlanivimab is a single IV infusion of 700 mg administered as soon as possible after testing positive for SARS-CoV-2 and within 10 days of symptom onset.

US_cFAQ_BAM010_DOSE_CRITERIA_FOR_USE_COVID-19
US_cFAQ_BAM010_DOSE_CRITERIA_FOR_USE_COVID-19
en-US

Bamlanivimab Emergency Use Authorization

Bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat 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 progressing to severe COVID-19 and/or hospitalization.1,2

Bamlanivimab is authorized only for the 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 progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.1,2

For information on the authorized use of bamlanivimab and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at bamlanivimab.com. 

Limitations of Authorized Use

Bamlanivimab is not authorized for use in patients

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • 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.2

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 with COVID-19.2

Bamlanivimab Fact Sheet for Healthcare Providers

Contraindications

There are no known contraindications for bamlanivimab.2

Bamlanivimab Dosing

Patient Selection and Treatment Initiation

Bamlanivimab is permitted for emergency use for the 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 progressing to severe COVID-19 illness and/or hospitalization.2,3

High risk is defined as patients who meet at least one of the following criteria:

  • Have a BMI ≥ 35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥ 65 years of age
  • Are ≥ 55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Are 12-17 years of age AND have
    • BMI ≥ 85th percentile for their age and gender based on CDC growth charts,4 OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.2

Recommended Dosage

The dosage of bamlanivimab in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is bamlanivimab 700 mg.2

Administer bamlanivimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.2

Bamlanivimab must be diluted and administered as a single IV infusion via pump or gravity.2

Dosage Adjustment in Specific Populations

No dosage adjustment is recommended based on age, sex, race, body weight, renal or mild hepatic impairment, during pregnancy or while lactating, or for disease severity or inflammation.

  • Based on population PK analysis, there is no significant difference in PK of bamlanivimab in patients with mild hepatic impairment compared to patients with normal hepatic function.2
  • Bamlanivimab has not been studied in patients with moderate or severe hepatic impairment.2

Bamlanivimab Available Clinical Data

BLAZE-1 SARS-CoV-2 Permitted Testing

Any type of direct SARS-CoV-2 testing was permitted in the BLAZE-1 clinical trial, provided it was an FDA-approved test to allow for maximum flexibility at clinical trial sites.5,6

Direct SARS-CoV-2 Viral Testing

Viral testing determines COVID-19 infection by detecting SARS-CoV-2 nucleic acid or antigen from the respiratory system (such as nasal or oral swabs or saliva) or blood. Therefore, viral tests directly test acute infection.7

SARS-CoV-2 Antibody Testing

The FDA has not authorized using antibody tests to diagnose SARS-CoV-2 infection, the virus that causes COVID-19. Antibody tests do not directly test for acute viral infection. Antibody tests can help determine whether the individual being tested was previously infected.7

Healthcare Setting for Patient Selection and Treatment Initiation

Bamlanivimab should not be used in patients who are hospitalized due to COVID-19.2

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 with COVID-19.2

However, if patient selection criteria are met for a patient who is hospitalized, but not due to COVID-19, bamlanivimab may be considered. 

Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.2

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1United States Food and Drug Administration. Bamlanivimab FDA Emergency Use Authorization Letter. Issued November 9, 2020. Accessed November 9, 2020. http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf

2U. S. Food and Drug Administration (FDA). Fact Sheet for Health Care Providers. Emergency Use Authorization (EUA) of bamlanivimab. 2021.

3COVID-19: developing drugs and biological products for treatment or prevention: guidance for industry. US Food and Drug Administration. Updated May 11, 2020. Accessed January 14, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/covid-19-developing-drugs-and-biological-products-treatment-or-prevention.

4Centers for Disease Control and Prevention. Clinical Growth Charts. Updated June 16, 2017. Accessed November 5, 2020. https://www.cdc.gov/growthcharts/clinical_charts.htm

5Chen P, Nirula A, Heller B, et al; BLAZE-1 Investigators. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with covid-19. N Engl J Med. Published online October 28, 2020. https://doi.org/10.1056/nejmoa2029849

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

7Overview of Testing for SARS-CoV-2 (COVID-19). Center for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Published October 21, 2020. Accessed November 18, 2020.

Glossary

BMI = body mass index

COVID-19 = coronavirus disease 2019

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

SpO2 = peripheral capillary oxygen saturation

Date of Last Review: March 03, 2021


Contact Lilly

Call Us

If you have immediate questions regarding COVID-19, or to report an Adverse Event or Product Complaint, please call us.

Daily Live Support: 9am to 7pm ET.
After Hours: Call Back Support Available

Or you can

Chat with us

Chat with us

Submit a Request

Visit Us @LillyMedical