Teverinofusp alfa is a lyophilized powder for injection. Its storage involves three different stages: unopened original packaging, after reconstitution, and after dilution. Each stage has strict requirements for temperature, humidity, and time.

I. Storage of Original Packaging

1. Temperature Requirements

(1) Must be stored under refrigeration at a temperature between 2°C and 8°C (36°F to 46°F).

(2) Do not freeze. Freezing will destroy the structural integrity of the active pharmaceutical ingredient.

2. Packaging Protection

(1) Should be kept in the original carton to protect from light.

(2) The original packaging provides effective light protection, preventing light exposure from affecting product quality.

3. Handling Prohibitions

(1) Do not shake. Shaking may cause protein aggregation or degradation.

(2) Before reconstitution, remove from the refrigerator and allow the vial to warm naturally at room temperature for 15 to 30 minutes.

(3) Do not use external heat sources (e.g., hot water, heaters) to accelerate warming.

II. Storage After Preparation

1. Storage After Reconstitution (not yet diluted)

(1) If not diluted immediately after reconstitution, it may be stored at room temperature (20°C to 25°C).

(2) The storage time must not exceed 4 hours.

(3) If not diluted within 4 hours, it must be discarded and not used further.

2. Storage After Dilution (already diluted in infusion bag)

(1) If not infused immediately after dilution, it should be stored under refrigeration (2°C to 8°C).

(2) The total refrigerated storage time must not exceed 24 hours.

(3) If stored for more than 24 hours, it must be discarded and not used further.

3. Visual Inspection of Solution

(1) After reconstitution, visually inspect the solution.

(2) An acceptable solution should be clear to slightly opalescent, colorless to pale brownish-yellow, and free of visible particles.

(3) If discoloration, turbidity, or visible particles are observed, it must be discarded.

III. Preparation Before Infusion

1. Time Limit After Removal from Refrigeration

(1) After removal from refrigeration, the diluted solution must be infused within 10 hours.

(2) Do not return to refrigeration after removal, to avoid temperature fluctuations that may affect stability.

2. Warming Before Infusion

(1) The refrigerated diluted solution should be allowed to reach room temperature before infusion, but the warming time counts toward the above 10‑hour limit.

(2) Do not use microwave ovens, hot water baths, or other heating methods to accelerate warming.

3. Discard Criteria

(1) Solutions meeting any of the following conditions should be discarded:

(2) Reconstituted solution stored at room temperature for more than 4 hours without dilution.

(3) Diluted solution refrigerated for more than 24 hours.

(4) Diluted solution removed from refrigeration and not infused within 10 hours.

(5) Solution with abnormal appearance.

(6) Any solution that has been frozen or shaken under any circumstances.

4. General Prohibitions for All Stages

(1) Freezing is prohibited at all stages (original packaging, after reconstitution, after dilution).

(2) Shaking is prohibited at all stages.

(3) For single use only. Any unused portion after reconstitution should be discarded and not saved for later use.