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Bamlanivimab;EtesevimabIndiaSnapshot

Indication and Dosage

NOTE: This information is based on international data. Refer to local guidance for specific approved regimens.

Indication (1)(2)

For the treatment of mild to moderate COVID-19 in adult patients

Dosage (1)(3)(4)

700 mg bamlanivimab and 1,400 mg etesevimab administered together as a single intravenous infusion

Administration

Administration: (3)(4)

Bamlanivimab and etesevimab are supplied in individual single-dose vials

  • Each dose required 1 bamlanivimab vial and 2 etesevimab vials

  • Prior to dilution, the product must be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F)

Dilute dose in a 50 mL, 100 mL, 150 mL, or 250 mL 0.9% Sodium Chloride Injection prefilled infusion bag

Administer together as a single intravenous infusion as soon as possible after positive test for SARS-CoV-2

Minimum infusion time depends on size of infusion bag used as follows:

  • 50 mL bag: Infuse over at least 21 minutes

  • 100 mL bag: Infuse over at least 31 minutes

  • 150 mL bag: Infuse over at least 41 minutes

  • 250 mL bag: Infuse over at least 70 minutes if patient weighs less than 50 kg and over at least 60 minutes if patient weighs 50 kg or more

Precautions

Precautions: (3)(4)

Infusion-related reactions have been observed and may be severe or life-threatening

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

  • Consider slowing/stopping the infusion and administering supportive care

Serious hypersensitivity reactions, including anaphylaxis, have been observed

  • If a clinically significant reaction develops, immediately discontinue treatment and administer supportive care

Pregnancy:

  • Only use during pregnancy if potential benefits outweigh potential risk

  • No adequate data regarding treatment of pregnant women

Adverse Reactions

Adverse Reactions: (3)(4)

  • Infusion-related reactions: dizziness, nausea, pruritus

  • Hypersensitivity reactions: anaphylaxis

Drug Interactions

Drug Interactions: (5)

COVID-19 vaccines:

  • Defer COVID-19 vaccination for at least 90 days as a precaution to avoid interference with vaccine-induced immune responses

  • Conversely, use/timing of bamlanivimab; etesevimab should not be affected by prior vaccinations in patients who develop COVID-19 after receiving the vaccine

References:

  1. Timesnownews.com. DCGI gives emergency use approval to Eli Lilly’s antibody drug to treat COVID-19 patients. Retrieved June 7, 2021. Available on the World Wide Web at: https://www.timesnownews.com/india/article/eli-lilly-gets-dcgi-emergency-use-approval-for-its-monoclonal-antibody-drugs-for-treatment-of-covid-patients/764729

  2. Reuters. Eli Lilly gets Indian emergency use nod for COVID-19 antibody drug combination. Retrieved June 7, 2021. Available on the World Wide Web at: https://www.reuters.com/world/india/eli-lilly-gets-indian-emergency-use-nod-antibody-drug-combination-2021-06-01/

  3. Eli Lilly. Emergency Use Authorization (EUA) for the treatment of COVID-19. Retrieved June 7, 2021. Available on the World Wide Web at: https://www.covid19.lilly.com/bam-ete/hcp

  4. Food and Drug Administration (FDA). Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. Retrieved May 19, 2021. Available on the World Wide Web at: https://www.fda.gov/media/145802/download

  5. COVID-19 Treatment Guidelines Panel. Coronavirus Diseases 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Accessed April 21, 2021. Available on the World Wide Web at: https://covid19treatmentguidelines.nih.gov/