Navepegritide, as a biologic macromolecular drug, has active ingredients sensitive to temperature, light, and time, requiring strict management across three levels: refrigerated storage, room temperature storage, and use after reconstitution.

I. Standard Refrigerated Storage Requirements

1. Temperature Range and Placement

(1) Standard temperature: Must always be stored in a refrigerator at 2°C to 8°C (36°F to 46°F).

(2) Placement: Place in the middle shelf of the refrigerator, away from the cooling air outlet, inner walls, or the freezer door, to prevent local overcooling and freezing.

(3) Temperature monitoring: It is recommended to regularly check with a refrigerator thermometer to ensure a stable refrigerated environment, and avoid frequent door opening that causes temperature fluctuations.

2. Protection from Light and Packaging

(1) Keep in original packaging: Before use, the drug should be kept in its original carton, which effectively blocks light and prevents photodegradation.

(2) Avoid prolonged exposure in transparent containers: Do not remove the drug and leave it exposed to direct sunlight or strong artificial light.

3. Absolute Prohibition of Freezing

(1) Freezing is forbidden: The solution must never be frozen, as freezing can destroy the active structure and excipient stability.

(2) Accidental freezing: If the vial or diluent syringe is found to be frozen, discard the set; do not use after thawing.

II. Room Temperature Storage Conditions and Time Limits

1. Total Time After Removal from Refrigeration

(1) Cumulative room temperature period: From the first time the drug is removed from refrigeration, it may be stored at room temperature not exceeding 30°C (86°F) for a cumulative maximum of 6 months.

(2) May be returned to refrigeration: Within the above 6‑month period, the drug may be placed back in the refrigerator, but the total storage time must not exceed 6 months or the expiry date, whichever comes first.

2. Appropriate Scenarios for Room Temperature Storage

(1) Travel or daily access: Suitable for short‑term外出 carrying, avoiding repeated refrigeration retrieval, or temporary storage when refrigerator space is insufficient.

(2) Record the date of first removal: It is recommended to mark on the carton the date when the drug was first removed from refrigeration, to facilitate calculation of the remaining allowable room temperature storage time.

3. Cross‑Constraints with Expiry Date

(1) Dual cut‑off rule: The date of use termination is the earlier of the drug’s original expiry date and 6 months after the first removal from refrigeration.

(2) Discard if expired: If either cut‑off is exceeded, the drug must not be used and should be safely discarded immediately.

III. Storage and Use Time Limits After Reconstitution

1. Room Temperature Environment After Reconstitution

(1) Temperature restriction: After reconstitution with the diluent, the solution must be kept at room temperature not exceeding 30°C (86°F).

(2) Do not refrigerate again: The reconstituted solution must not be returned to the refrigerator, nor frozen; it may only be temporarily stored at room temperature.

2. Strict Administration Window

(1) 4‑hour validity: The injection must be completed within 4 hours after reconstitution; if not used within this time, it must be discarded.

(2) Discard principle: Regardless of the remaining volume in the vial, it must not be used after 4 hours, nor saved for a later injection.

3. Visual Inspection and Time Correlation After Reconstitution

(1) Inspect before each use: Within the 4‑hour validity, before each withdrawal, check that the solution remains colorless and clear.

(2) Discard if abnormal: If turbidity, discoloration, or visible particles appear, even if within 4 hours, immediately stop use and discard.