Monograph: Bamlanivimab and Etesevimab

Bamlanivimab and Etesevimab

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Full Title

Bamlanivimab and Etesevimab

Generic Name

Bamlanivimab; Etesevimab

INV Number

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Classification

Introduction

Introduction

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Description

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Spectrum

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Resistance

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Table 3. Pseudotyped VLP Neutralization Data for SARS-CoV-2 Variant Substitutions and Bamlanivimab and Etesevimab Together (1:2 Molar Ratio).1

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Table 4. Authentic SARS-CoV-2 Neutralization Data for Bamlanivimab and Etesevimab Together (1:2 Molar Ratio).1

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Uses

Uses

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Coronavirus Disease 2019 (COVID-19)

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Emergency Use Authorization (EUA)

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National Institutes of Health (NIH) Guidelines for Treatment of COVID-19

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Infectious Diseases Society of America (IDSA) Guidelines for Treatment of COVID-19

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Outpatients with Mild to Moderate COVID-19

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BLAZE-1 Trial

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Patients Hospitalized with COVID-19

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Prevention of COVID-19

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Dosage and Administration

Dosage and Administration

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General

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Administration

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IV Infusion

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Rate of Administration

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Table 1. Recommended IV Infusion Rate of Combined Bamlanivimab (700 mg) and Etesevimab (1.4 g) Diluted in 0.9% Sodium Chloride in Adults and Pediatric Patients 12 Years of Age or Older Weighing 50 kg or More1

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Table 2. Recommended IV Infusion Rate of Combined Bamlanivimab (700 mg) and Etesevimab (1.4 g) Diluted in 0.9% Sodium Chloride in Adults and Pediatric Patients 12 Years of Age or Older Weighing 40 kg to less than 50 kg1

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Dosage

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Adult Dosage

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Outpatients with Mild to Moderate Coronavirus Disease 2019 (COVID-19)

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Pediatric Dosage

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Outpatients with Mild to Moderate Coronavirus Disease 2019 (COVID-19)

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Special Populations

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Hepatic Impairment

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Renal Impairment

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Geriatric Patients

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Cautions

Cautions

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Contraindications

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Warnings/Precautions

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Sensitivity and Infusion-related Reactions

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Clinical Worsening after SARS-CoV-2-specific Monoclonal Antibody Administration

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

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EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

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Specific Populations

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Pregnancy

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Lactation

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Pediatric Use

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Geriatric Use

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Hepatic Impairment

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Renal Impairment

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Common Adverse Effects

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Drug Interactions

Drug Interactions

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Vaccines

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COVID-19 Vaccines

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Pharmacokinetics

Pharmacokinetics

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Absorption

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Distribution

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Elimination

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Special Populations

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Stability Section

Stability

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Solution Concentrates for Injection, for IV Infusion

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Advice to Patients

Advice to Patients

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Preparations

Preparations

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Bamlanivimab

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Etesevimab

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Common general statement Elements

Additional Information

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References

References

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Copyright

AHFS® Drug Information. © Copyright, 1959-2021, Selected Revisions August 30, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Quelle

AHFS Drug Information