As a protein-based biologic, Lumvoa's stability is highly sensitive to environmental conditions. Proper storage and handling are fundamental to ensuring drug efficacy and safety, spanning the entire process from original packaging to infusion completion.

I. Storage of Unopened Original Packaging

1. Refrigerated Temperature Requirements

(1) Unopened Lumvoa single-dose vials must be stored in a refrigerated environment at 2°C to 8°C (36°F to 46°F).

(2) This temperature range maintains the conformational stability of the antibody molecule, preventing degradation or aggregation.

2. Light Protection and Packaging

(1) The drug should always be kept in the original carton to avoid direct light exposure or prolonged exposure to intense indoor lighting.

(2) The original packaging provides excellent light-shielding properties and is the most reliable physical barrier during transport and storage.

3. Freezing and Shaking Prohibited

(1) Lumvoa must never be placed in a freezer or in environments below 0°C, as freezing will cause protein denaturation and inactivation.

(2) Additionally, vigorous shaking or inversion should be avoided even when unopened, to prevent bubble formation or compromise solution homogeneity.

II. Storage of Diluted Infusion Bags

1. Room Temperature Storage Duration

(1) After dilution with 0.9% sodium chloride injection, if stored at room temperature (20°C to 25°C), the time from preparation to start of infusion must not exceed 4 hours.

(2) Beyond this time limit, the solution must be discarded and must not be re-refrigerated for later use.

2. Refrigerated Storage Conditions

(1) The diluted solution may be stored under refrigeration at 2°C to 8°C for up to 72 hours, and must be protected from light.

(2) If infusion is to be delayed, the solution should be prepared and immediately transferred to the refrigerator within the specified time frame; do not leave it at room temperature before refrigeration.

3. Rewarming after Refrigeration

(1) If the diluted solution has been refrigerated, it must be allowed to warm to room temperature before infusion. Do not use forced heating methods such as microwaves or direct heat.

(2) Infusion should commence as soon as possible after rewarming; avoid repeated cold‑warm cycles.

III. Compatibility of Ancillary Materials and Inspection Procedures

1. Infusion Set Compatibility

Lumvoa diluted solution is compatible with infusion sets made of various materials; use of incompatible materials may affect drug stability.

2. Visual Inspection after Preparation

(1) Prior to each infusion, the diluted solution must be visually inspected.

(2) It should normally appear colorless to pale yellow, clear to slightly opalescent, and free of visible particulates.

(3) If turbidity, precipitate, discoloration, or foreign matter is observed, the solution must be discarded immediately regardless of storage conditions and must not be used.

3. Disposal of Remaining Drug Solution

(1) Lumvoa contains no preservatives; each vial is for single-use only.

(2) Any unused contents in vials after preparation, remaining liquid in infusion bags, and any diluted solution that exceeds the storage time limit must be properly discarded as medical waste and not saved for future use.

4. Avoiding Cross‑Contamination

(1) During preparation, sterile syringes and needles must be used. First, withdraw an volume of normal saline from the infusion bag equal to the drug volume to maintain the total volume, then inject Lumvoa.

(2) All operations must be performed in a clean environment to prevent microbial contamination that could affect storage stability.