Proper storage is the key to ensuring the efficacy and safety of epoetin alfa. Improper storage, such as freezing or shaking, may lead to protein denaturation and loss of activity, and may even cause adverse reactions.

I. Core Storage Conditions and Requirements

1. Strict Cold Chain Management

(1) Epoetin alfa must be stored in a refrigerator under refrigeration, with the temperature strictly controlled between 2°C and 8°C (36°F to 46°F).

(2) Do not place it in the freezer or in any environment where freezing may occur.

2. Do Not Shake

(1) Shaking can cause aggregation and denaturation of the active protein (erythropoietin) in the drug, thereby losing therapeutic activity.

(2) Handle and transport with care, avoiding vigorous agitation.

3. Protect from Light

The original carton provides good light protection. Unused vials should always be stored in the carton until ready for use, to prevent light exposure from affecting drug stability.

4. Identification of Deteriorated Drug

If the solution is found to have been frozen or appears turbid, contains particulate matter, or has changed color, the drug has deteriorated and must be discarded immediately. Do not use it.

II. Post-Puncture Shelf Life for Different Vial Types

1. Single-Dose Vial (Without Preservative)

(1) This formulation contains no antimicrobial preservative and is for single-use only.

(2) After opening or puncturing, any unused remaining solution must be discarded immediately. Do not re-puncture for additional withdrawal.

2. Multiple-Dose Vial (Containing Benzyl Alcohol)

(1) After the first puncture, the vial may be stored under refrigeration (2-8°C) for up to, but not exceeding, 21 days.

(2) After this period, discard any remaining amount regardless of volume.

III. Special Considerations for Preparation and Storage

1. Do Not Dilute or Mix

(1) This product should generally not be diluted, nor should it be mixed with other drug solutions for infusion.

(2) Only in specific cases may the solution from a single-dose vial be mixed 1:1 with bacteriostatic saline containing benzyl alcohol, but this must be prepared immediately before administration.

2. Important Compatibility Contraindication

When preparing the drug for neonates, infants, pregnant women, or breastfeeding women, absolutely do not use bacteriostatic saline containing benzyl alcohol for mixing, to prevent serious toxic reactions caused by benzyl alcohol.

3. Information for Home-Use Patients

For patients who have been trained to self-inject at home, special attention should be paid to:

(1) Strictly follow the prescription guidance for carrying and storing the drug. For short trips, a cold pack may be used.

(2) All used syringes and needles should be placed in a dedicated sharps container and not discarded arbitrarily.

(3) After the first use of a multiple-dose vial, be sure to mark the opening date on the vial label so that it can be discarded on time.