What is the proper method for mixing and administering Opdivo (nivolumab)?

How to Mix and Administer Opdivo (Nivolumab)

Opdivo (nivolumab) should be administered as an intravenous infusion after proper dilution with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final concentration between 1 mg/mL and 10 mg/mL. The medication requires careful preparation to ensure proper administration and patient safety.

Preparation Instructions

Visual Inspection

• Visually inspect the Opdivo solution for particulate matter and discoloration
• Opdivo should appear as a clear to opalescent, colorless to pale-yellow solution
• Discard if cloudy, discolored, or contains extraneous particulate matter (other than a few translucent-to-white proteinaceous particles)
• Do not shake the vial

Dilution Process

1. Withdraw required volume of Opdivo from the vial
2. Transfer into an intravenous container
3. Dilute with either:
   • 0.9% Sodium Chloride Injection, USP or
   • 5% Dextrose Injection, USP
4. Final concentration must be between 1 mg/mL and 10 mg/mL
5. Total volume limitations:
   • For patients ≥40 kg: Do not exceed 160 mL total infusion volume
   • For patients <40 kg: Do not exceed 4 mL/kg of body weight
6. Mix diluted solution by gentle inversion (do not shake)

Storage After Preparation

After preparation, store the diluted solution either:

• At room temperature and room light for no more than 8 hours from preparation to end of infusion, OR
• Under refrigeration at 2°C to 8°C (36°F to 46°F) and protected from light for no more than 7 days from preparation to end of infusion

Administration Instructions

1. Administer the infusion over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size 0.2-1.2 micrometers)

2. When administering in combination with other therapies:

   • With ipilimumab: administer Opdivo first, followed by ipilimumab on the same day
   • With chemotherapy: administer Opdivo first, followed by chemotherapy on the same day

3. Important administration notes:

   • Use separate infusion bags and filters for each infusion
   • Flush the intravenous line at the end of infusion
   • Do not co-administer other drugs through the same intravenous line

Common Dosing Regimens

Based on the most recent guidelines 1, Opdivo may be administered in the following regimens:

• Monotherapy:

  • 240 mg intravenously every 2 weeks, OR
  • 480 mg intravenously every 4 weeks, OR
  • 3 mg/kg intravenously every 2 weeks

• Combination with ipilimumab:

  • Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses, followed by nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks

Safety Considerations

• Opdivo can cause severe immune-mediated adverse reactions
• Monitor patients closely during and after administration
• Have appropriate management protocols ready for potential immune-related adverse events
• Discard partially used vials or empty vials of Opdivo as the product does not contain a preservative

Following these specific preparation and administration guidelines will help ensure the safe and effective delivery of Opdivo to patients 2.