Bamlanivimab Administration Under Emergency Use Authorization

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Tina Marie Collins
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Joined: 04/01/2019 - 16:26
Bamlanivimab Administration Under Emergency Use Authorization

Looking at the info provided by Lilly:

Preparation and Administration
• The 700 mg dose MUST BE prepared using 0.9% sodium chloride.
• Preparation of 700 mg dose of bamlanivimab for IV infusion*
• Administration of a dose of 700 mg of bamlanivimab in an IV infusion*
• Bamlanivimab solution for infusion should be prepared by a qualified health care professional using aseptic technique.

• Remove ONE (1) vial of bamlanivimab injection, 700mg/20mL (drug product) from refrigerated storage
at 2°C to 8°C (36°F to 46°F), and equilibrate the vial to room temperature, not exceeding 30°C or 86°F
for approximately 20 minutes (or no longer cool to the touch). Do not expose to direct heat.

• Gently invert the vial by hand approximately 10 times to ensure homogeneity of the contents. Do not
shake or vigorously agitate the vial. Visually inspect the vial for the presence of any visible particulate
matter and discoloration. Bamlanivimab is a clear to slightly opalescent and colorless to slightly
yellow to slightly brown solution. If visible particulate matter is observed, appropriately discard the
vial, obtain a new vial, and restart the preparation, beginning at the prior step.

• Prepare the IV solution using the following approach using aseptic technique.
• The IV solution can be prepared using a filled 250mL IV bag. Using a syringe with an 18-gauge
needle, withdraw a total of 70mL of 0.9% sodium chloride from the IV bag and discard that
volume, leaving 180mL in the IV bag.
• Using a new, sterile syringe with an 18-gauge needle, withdraw 20mL of bamlanivimab from
the prepared vial and inject the contents into the prepared IV bag, so that the combined total
volume is 200mL.
• Gently invert the prepared IV bag by hand approximately 10 times to ensure homogeneity of the
contents. Do not shake or vigorously agitate the prepared bag. Avoid foaming. Visually inspect the bag
after preparation. The contents of the bag should be free of any visible particulate matter. Obtain new
vial(s) and re-prepare the dose if visible particulate matter is observed.
• Attach an infusion set containing a 0.20/0.22 μm filter to the IV bag.
• Prime the infusion set and adjust for a flow rate of 200mL/hr for both infusion pumps and gravity
infusion. Administer the infusion solution over 60 minutes.

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What logistical concerns have you worked through at your sites? Are you considering having nursing mix and administer this for any sites that are not 24 hour staffed by a pharmacist?

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