Cabazitaxel, as a lyophilized powder for injection or as an injectable solution, has storage and post‑reconstitution management requirements that are directly related to medication safety.
I. Storage Requirements for the Original Packaged Drug
1. Temperature Control
(1) Cabazitaxel injection (unopened) should be stored at 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F).
(2) Refrigeration or freezing is strictly prohibited. Do not place in a refrigerator or freezer, as this may affect the physical properties of the excipients.
2. Protection from Light and Moisture
(1) The drug should be kept in the original carton to protect from direct sunlight and intense light.
(2) It should be stored in a dry, cool place away from heat sources (e.g., radiators, kitchen steam) and humid environments to prevent damage to the packaging or detachment of labels.
3. Expiry Date and Inspection
(1) Check the expiry date on the drug packaging. Expired product must not be used.
(2) Before each use, observe whether the solution is clear and appears as a yellow to brown‑yellow viscous liquid. If turbidity, precipitate, or abnormal colour is noted, discard the vial and contact the pharmacy for replacement.
II. Storage and Time Limits for Reconstituted Solutions
1. First Dilution (10 mg/mL)
(1) After reconstitution with the supplied diluent, the solution should be immediately used for the next dilution step. The maximum holding time should not exceed 30 minutes.
(2) This intermediate solution is not for direct infusion, and large‑volume preparation in advance is not recommended.
2. Final Infusion Solution
(1) After preparation, it may be used at room temperature (approximately 25°C) for a total duration (including the 1‑hour infusion) not exceeding 8 hours.
(2) If extended storage is needed, it may be stored under refrigeration at 2°C–8°C, with a total time from preparation to the end of infusion not exceeding 24 hours.
(3) After refrigeration, allow the solution to return to room temperature before use and inspect for crystals or precipitate.
3. Avoiding Crystallisation
(1) Because the final solution is supersaturated, prolonged storage or improper temperature may lead to crystal formation.
(2) A visual inspection must be performed before infusion. If particulate matter or crystals are observed, the solution must be discarded immediately and not used.
III. Special Handling and Safety Precautions
1. Preparation and Operational Standards
(1) Cabazitaxel is a hazardous antineoplastic agent. Preparation should be carried out in a dedicated biological safety cabinet, and operators must wear protective gloves, goggles, and protective gowns.
(2) The preparation area should be equipped with emergency eyewash stations and waste disposal containers to manage accidental spills.
2. Choice of Infusion Set
(1) PVC‑containing infusion containers or polyurethane tubing must not be used, as they may adsorb the drug or leach plasticisers.
(2) Non‑PVC infusion bags and tubing must be used, and a 0.22‑micron (0.2‑micron) in‑line filter must be attached for infusion.
3. Disposal of Remaining Solution and Waste
(1) All unused prepared solution, empty vials, and materials that have come into contact with the drug must be disposed of as cytotoxic waste according to regulations. Do not pour down the drain or mix with ordinary trash.
(2) If the solution accidentally contacts skin or mucous membranes, wash immediately with plenty of soap and water, and seek medical attention if necessary.
4. Transport and Dispensing Reminders
(1) During transport, avoid vigorous shaking and extreme temperatures. Use insulated containers and record temperature monitoring data.
(2) When dispensing, hospital pharmacies should retain the original packaging and package insert to ensure that patients or caregivers are informed of the correct storage methods.
