10,000 Units/mL and 20,000 Units/mL Multiple-Dose Vials FREEZEmarker® Indicator

SUMMARY

The manufacturer cannot recommend any practices, procedures, or storage conditions that deviate from product labeling for epoetin alfa.¹ Data regarding the epoetin alfa multiple-dose vial, specifically freezing stability and the FREEZEmarker^® indicator, are provided below.

PRODUCT LABELING

PROCRIT is formulated as a sterile, colorless, preservative-free liquid with each single-dose vial containing 2000, 3000, 4000, 10,000 or 40,000 Units (U) of epoetin alfa per 1 mL. PROCRIT is also available in multiple-dose vials of 20,000 U (10,000 U/mL in a 2 mL vial, 20,000 U/mL in a 1 mL vial) that contain benzyl alcohol as a preservative.²

Please note the following as stated in the HOW SUPPLIED/STORAGE AND HANDLING and PREPARATION AND ADMINISTRATION sections of the PROCRIT Prescribing Information²:

• Store at 36°F to 46°F (2°C to 8°C).  Do not freeze.
• Store PROCRIT vials in the original carton until use to protect from light.
• Do not shake. Do not use PROCRIT that has been shaken or frozen.
• Protect vials from light.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration.
• Discard unused portions of PROCRIT in preservative-free vials. Do not re-enter preservative-free vials.
• Store unused portions of PROCRIT in multiple-dose vials at 36°F to 46°F (2°C to 8°C). Discard 21 days after initial entry
• Do not dilute.  Do not mix with other drug solutions except for admixing as described below:
  • Preservative-free PROCRIT from single-dose vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration.
  • Do not mix PROCRIT with bacteriostatic saline when administering to pregnant women, lactating women, neonates, and infants (see Use in Specific Populations).
• PROCRIT from multiple-dose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women (see Use in Specific Populations).

stability and excursion data

Freezing Stability

Preserved, multiple-dose vials: 20,000 U/2mL and 20,000 U/mL

• The manufacturer does not have stability data to support the use of epoetin alfa multiple-dose vials exposed to temperatures below 2°C (36°F). Epoetin alfa multiple-dose vials exposed to temperatures below the recommended temperature range of 2°C to 8°C (36°F to 46°F) should not be used. A temperature indicator called a ‘FREEZEmarker’ is contained within the carton and will be triggered when exposed to freezing temperatures. Epoetin alfa should be shipped and stored in its original packaging.¹

Multiple-dose Vial: FREEZEmarker Indicator

Preserved, multiple-dose vials: 20,000 U/2mL and 20,000 U/mL

The FREEZEmarker single-use indicator will irreversibly change from green to white when the product has been exposed to freezing temperatures. It is only used to determine whether product has been exposed to freezing temperatures. The FREEZEmarker is a single-use freeze indicator that provides an easy-to-read, irreversible visual signal when a freeze event at or below the response temperature occurs. The green circle and white checkmark are visible in the indication window at temperatures above the response temperature. When exposed to temperatures at or below the response temperature, the green circle and white checkmark will turn partially or completely white (opaque/cloudy), showing that a temperature excursion has occurred and endpoint has been reached.³

• If the FREEZEmarker indicator has been triggered, contact the Medical Information Department at 1-800-526-7736 to report the event.³

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 09 July 2025.