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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

One Vial of Bamlanivimab Must Be Combined with Two Vials of Etesevimab for Infusion

You must add one vial bamlanivimab and two vials etesevimab to the infusion bag.

  1. Bamlanivimab and etesevimab can be added to either 50mL, 100mL, 150mL, or 250mL Sodium Chloride infusion bags.
  2. Remove one vial of bamlanivimab and two vials of etesevimab from the refrigerator and allow to equilibrate to room temperature (approximately 20 minutes). Do not heat. Do not shake.
  3. Vials should be free of particulates, clear to slightly opalescent, colorless to slightly yellow to slightly brown. If not, discard.
  4. Withdraw 20 mL of bamlanivimab and inject infusion bag of 0.9% sodium chloride.
  5. Withdraw 2 0 mL of etesevimab from each of the two vials (total 40 mL) and inject into the infusion bag.
  6. Discard any remaining product remaining in the vials.
  7. Invert infusion b ag approximately 10 times to mix. Do not shake.

Dosage

Dosage in adults and in pediatric patients (12 years of age and older weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous infusion over at least 60 minutes For more information, please review the IHS NPTC clinical guidance document located on the IHS NPTC COVID-19 Resource page.

Storage

Solution should be administered immediately. If not used immediately, may store in refrigerator (36 - 46℉) for up to 24 hours (including infusion time). If refrigerated, allow injection bag to equilibrate to room temperature (approximately 20 minutes). May store at room temperature (68 - 77℉) for up to 7 hours (including infusion time).

Infusion Times

Infusion times are based upon patient weight and the size of Sodium Chloride infusion bag.

Infusion Time for Patients Weighing ≥ 50 kg
Size of Sodium Chloride infusion bag Maximum infusion rate Minimum infusion time
50 mL 310 mL/hr 21 minutes
100 mL 310 mL/hr 31 minutes
150 mL 310 mL/hr 41 minutes
250 mL 310 mL/hr 60 minutes
Infusion Time for Patients Weighing < 50 kg
Size of Sodium Chloride infusion bag Maximum infusion rate Minimum infusion time
50 mL 310 mL/hr 21 minutes
100 mL 310 mL/hr 31 minutes
150 mL 310 mL/hr 41 minutes
250 mL 266 mL/hr 70 minutes

Safety

Bamlanivimab and etesevimab have been associated with cases of anaphylaxis and Infusion related reactions ( difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e. 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).

To help the FDA track safety issues with bamlanivimab and etesevimab, please report adverse events to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting to MedWatch can be found online at the NPTC Pharmacovigilance website.

  • Submitted reports should include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “bamlanivimab and etesevimab use for COVID-19 under Emergency Use Authorization (EUA)”
  • Submitted reports should include “IHS” in the Reporter Section (Section G).

Healthcare facilities and providers must report therapeutics information and utilization data through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Service.