Loargys, as a protein-based enzyme replacement therapy, has strict storage requirements. Proper storage and handling directly affect the stability and efficacy of the drug, and are also critical to ensuring medication safety.
I. Storage Requirements for Unopened Vials
1. Refrigerated Temperature Range
(1) Unopened vials must be stored in a refrigerated environment at 2°C to 8°C.
(2) This temperature range is essential for maintaining drug activity; exceeding this range may lead to protein degradation or aggregation, compromising efficacy.
2. Store in Original Carton to Protect from Light
(1) Vials should always be kept in the original carton to protect from direct light exposure.
(2) Light exposure may accelerate oxidation and degradation of the protein components in the drug; the original carton provides light-shielding protection.
3. Do Not Freeze
(1) Freezing of Loargys is strictly prohibited.
(2) Freezing causes irreversible changes to the protein structure. After thawing, the drug not only loses activity but may also develop particulates or aggregates, and must not be used.
4. Do Not Shake
(1) Avoid vigorous shaking of the vial during storage and handling.
(2) Protein drugs are sensitive to mechanical stress; excessive shaking may cause protein aggregation, affecting solution appearance and biological activity.
II. Storage Duration After Preparation
1. Storage of Diluted Solution for Intravenous Administration
(1) After diluting Loargys with 0.9% sodium chloride injection, the solution in the intravenous infusion bag should be used as soon as possible.
(2) If immediate use is not possible, it may be stored temporarily under the following conditions:
(2.1) At room temperature (20°C to 25°C) for no more than 2 hours, or under refrigeration (2°C to 8°C) for no more than 4 hours.
(2.2) Beyond these time limits, the solution must be discarded and not used.
(3) This time frame includes the duration of the intravenous infusion itself, i.e., the total time from preparation to completion of infusion must not exceed the respective limit.
2. Storage of Undiluted Solution for Subcutaneous Administration
(1) Undiluted original solution drawn into a syringe should also be injected as soon as possible.
(2) If temporary storage is necessary, the time limits are the same as for diluted solution: no more than 2 hours at room temperature, or no more than 4 hours under refrigeration.
(3) The original solution for subcutaneous injection must not be diluted; after drawing, if not used within the specified time, it must be discarded.
III. Routine Handling Precautions and Withdrawal Guidelines
1. Allow to Reach Room Temperature Before Withdrawal
(1) After removing the vial from the refrigerator, allow it to reach room temperature before preparing or withdrawing the dose.
(2) Withdrawing or diluting when the solution is too cold may affect the accuracy of operation and mixing uniformity.
(3) Use as soon as possible after removal; do not leave at room temperature for extended periods.
2. Visual Inspection Before Administration
(1) Before each use, carefully inspect the solution appearance. Normal Loargys should be a clear to slightly opalescent, colorless to slightly yellow or slightly pink solution.
(2) If any of the following conditions are observed, do not use and discard:
(2.1) Visible particulates or precipitate.
(2.2) Color markedly outside the normal range.
(2.3) Turbidity or stratification.
3. Single-Dose Vial – Discard After Use
(1) Loargys is supplied as a single-dose vial without preservatives.
(2) After withdrawing the required dose, any remaining solution in the vial must be discarded and not kept for subsequent administration.
(3) Each vial is for one-time use only.
4. Disposal of Unused Solution
Unused solution generated during preparation or withdrawal, solution that has exceeded the storage time limits, and solution that fails visual inspection must all be disposed of in accordance with the healthcare facility's biological hazardous waste management protocols; do not pour down the drain.
