IV ADMINISTRATION

IV PREPARATION

PREPARATION1

  1. NUZYRA® (omadacycline) must be reconstituted and then further diluted under aseptic conditions. Reconstitute and dilute the appropriate number of vials as determined from the table below.
  2. Reconstitute each 100 mg vial with 5 mL of Sterile Water, 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for Injection.
  3. Gently swirl contents and let vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial.
  4. If the NUZYRA solution is not yellow to dark orange, the reconstituted solution should be discarded. Prior to further dilution and administration, inspect for particulate matter and discoloration. If necessary, invert vial to dissolve any remaining powder and swirl gently to prevent foaming.
  5. Immediately (within 1 hour), withdraw 5 or 10 mL of reconstituted solution and further dilute to a 100 mL (nominal volume) of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, bag for injection. The concentration of the final diluted infusion will either be 1 mg/mL or 2 mg/mL, as per the table below. Discard any unused portion of reconstituted solution.
  6. As with all parenteral drug products, whenever solution and container permit, inspect visually for particulate matter and discoloration prior to administration.

RECONSTITUTION AND DILUTION1

PREPARATION OF NUZYRA IV INFUSION
NUZYRA FOR INJECTION DOSE NUMBER OF VIALS TO RECONSTITUTE FOR FURTHER DILUTION VOLUME OF RECONSTITUTED SOLUTION (5 mL/VIAL) TO WITHDRAW FOR FURTHER DILUTION FINAL INFUSION CONCENTRATION OF NUZYRA
200 mg
2 Vials
10 mL
2 mg/mL
100 mg
1 Vial
5 mL
1 mg/mL

STORAGE OF THE DILUTED INFUSION SOLUTION1

  • If at room temperature (≤25°C), use within 24 hours
  • If refrigerated (2°C to 8°C), use within 7 days
  • Do not freeze
Nuzyra Packaging

INFUSION INSTRUCTIONS (AFTER RECONSTITUTION AND DILUTION)1

  • Loading Dose: Use a total intravenous infusion time of 60 minutes for a 200 mg dose
    • Note: There is an alternative IV loading dose for CABP and ABSSSI of 100 mg to be administered twice on Day 1 over a period of 30 minutes
  • Once-Daily Maintenance Dose: Use a total intravenous infusion time of 30 minutes for a 100 mg dose
  • Administer through a dedicated line or through a Y-site
    • If the same intravenous line is used for sequential infusion of several drugs, flush the line before and after NUZYRA infusion, with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP
    • The compatibility of NUZYRA with other drugs and infusion solutions other than 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, has not been established

STORAGE AND HANDLING1

  • NUZYRA for Injection and NUZYRA Tablets should be stored 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
  • Do not freeze