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Stability and storage conditions: Store the vial in original package to protect from light. If refrigerated, a precipitate may form which redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy, or an insoluble precipitate is noted, the vial should be discarded. An expiry date is given on the outer carton and vial label of the product. It should not be used after this date.
After opening: From a microbiological point of view, once opened the product may be stored for a maximum of 28 days at 25°C. Other in-use storage times and conditions are the responsibility of the user.
Chemical and physical in-use stability of the solution prepared for infusion has been demonstrated at 5°C and at 25°C for 7 days when diluted in a 5% glucose solution and 5% glucose in Ringer solution for injection and for 14 days when diluted in sodium chloride 0.9%. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and usually should not be more than 24 hours at 2-8°C, unless the dilution is performed in controlled and validated aseptic conditions. After the dilution, the solution is for single use.
Incompatibilities: To minimise patient exposure to plasticizer DEHP (di-2-ethylhexyl phtalate), which may be leached from plasticised PVC infusion bags, sets, or other medical instruments, diluted paclitaxel solutions should be stored in non-PVC bottles (glass, polypropene) or plastic bags (polypropene, polyolefin) and administered through polyethene-lined administration sets. Use of filter devices (eg. IVEX-2) which incorporate short inlet and/or outlet plasticised PVC tubing has not resulted in significant leaching of DEHP.
Disposal: All items used for preparation, administration or otherwise coming into contact with paclitaxel should undergo disposal according to local guidelines for the handling of cytotoxic compounds.
