Limitations of Authorized Use for COVID-19:

This EUA is for the use of the unapproved product bamlanivimab 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 [see LIMITATIONS OF AUTHORIZED USE].

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

• Have a body mass index (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, https://www.cdc.gov/growthcharts/clinical_charts.htm, 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.

Bamlanivimab must be administered by intravenous (IV) infusion.

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.

Health care providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS potentially related to bamlanivimab. See Sections 8 and 9 of the Full EUA Prescribing Information for reporting instructions below.

• The authorized dosage for bamlanivimab is a single intravenous (IV) infusion of 700 mg administered as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
• Bamlanivimab is available as concentrated solution and must be diluted prior to administration.
• Administer bamlanivimab 700 mg via IV infusion over at least 60 minutes via pump or gravity.
• Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.
• Patients treated with bamlanivimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines.

The authorized dosage may be updated as additional data from clinical trials becomes available.

For information on clinical trials that are testing the use of bamlanivimab in COVID-19, please see www.clinicaltrials.gov.