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Dosage and Administration Overview

Bamlanivimab is a sterile, preservative-free solution available as:

  • Injection: 700 mg/20 mL (35 mg/mL) in a single-dose vial.

The dosage of bamlanivimab in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is bamlanivimab 700 mg, administered as a single IV infusion via pump or gravity.

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

No dosage adjustments are recommended for specific populations.

bamlanivimab vial box
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For full dosage and administration information, please see the Fact Sheet for Healthcare Providers.

Recommended dilution and administration instructions for bamlanivimaba

Drug: Bamlanivimab 1 vial (20 mL) add to infusion bag and administer as instructed below.
Size of prefilled 0.9% Sodium Chloride infusion bag Maximum Infusion Rate Minimum Infusion Time
Size of prefilled 0.9% Sodium Chloride infusion bag: 50 mL Maximum Infusion Rate: 270 mL/hr Minimum Infusion Time: 16 minutes
Size of prefilled 0.9% Sodium Chloride infusion bag: 100 mL Maximum Infusion Rate: 270 mL/hr Minimum Infusion Time: 27 minutes
Size of prefilled 0.9% Sodium Chloride infusion bag: 150 mL Maximum Infusion Rate: 270 mL/hr Minimum Infusion Time: 38 minutes
Size of prefilled 0.9% Sodium Chloride infusion bag: 250 mL Maximum Infusion Rate: 270 mL/hr Minimum Infusion Time: 60 minutes

a700 mg of bamlanivimab (20 mL) is added to an infusion bag and administered as a single intravenous infusion.

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Infusion Resources

For full dosage and administration information, please refer to the Fact Sheet for Healthcare Providers. You can also call the Lilly COVID Hotline at 1-855-545-5921.

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Storage

This product is preservative-free and should be administered immediately. If immediate administration is not possible, store the infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) and up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration.

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Preparation Materials

Bamlanivimab solution for infusion should be prepared by a qualified healthcare professional using aseptic technique. Gather the materials for preparation:

  • Polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC infusion, sterile pre-filled infusion bag. Choose one of the following sizes:
    • Prefilled 50 mL, 100 mL, 150 mL, or 250 mL infusion bag containing 0.9% Sodium Chloride Injection (see dosing table above for details).
  • One 20 mL vial of bamlanivimab (700 mg/20 mL).
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Handling of Vial

Remove one bamlanivimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vial. Inspect bamlanivimab visually for particulate matter and discoloration. (Bamlanivimab is a clear to opalescent and colorless to slightly yellow to slightly brown solution.) Withdraw 20 mL bamlanivimab from one 20 mL vial and inject into a prefilled infusion bag containing 0.9% Sodium Chloride Injection (see dosing table above for details). Discard any product remaining in the vial.

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Administration Materials

Bamlanivimab infusion solution should be administered by a qualified healthcare professional. Gather the materials for infusion:

  • Polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC infusion set.
  • Use of an in-line or add-on 0.20/0.22 micron polyethersulfone (PES) filter is strongly recommended.

Attach the infusion set to the IV bag. Prime the infusion set.

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Infusion

Administer the entire infusion solution in the bag via pump or gravity according to the size of infusion bag used (see dosing table above for details). Due to potential overfill of pre-filled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage.

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Post-Infusion

Once infusion is complete, flush the tubing with 0.9% Sodium Chloride to ensure delivery of the required dose. Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete. If the infusion must be discontinued due to an infusion reaction, discard any unused product. The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with bamlanivimab has not been studied.

Bamlanivimab is authorized for use for 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.

  • Bamlanivimab has not been approved, but has been authorized for emergency use by FDA.
  • Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the 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.

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.
  • 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 in hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Important Safety Information

There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use.

WARNINGS
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions have been observed with administration of bamlanivimab. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

  • fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Clinical Worsening After Bamlanivimab Administration

Clinical worsening after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

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 Limitations of Authorized Use.

Adverse Events

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%).

USE IN SPECIFIC POPULATIONS
Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers.

BAM HCP EUA ISI 28JAN2021

Fact Sheet for Healthcare Providers
Dear HCP Letter Correction of Drug Information: Preparation and Administration Instructions
Dear HCP Letter: Bamlanivimab and Etesevimab, Preventing Medication Errors
Fact Sheet for Patients, Parents and Caregivers (English)
Fact Sheet for Patients, Parents and Caregivers (Spanish)
FDA Letter of Authorization
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