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Special precautions for disposal and other handling: Handling: As with all antineoplastic agents, caution should be exercised when handling paclitaxel.
Pregnant women or women of childbearing potential must be warned to avoid handling cytotoxic agents.
Dilution should be carried out under aseptic conditions by trained personnel in a designated area. Adequate protective gloves should be worn. Contact with skin and mucous membranes should be avoided. In case of contact with skin, the skin should be washed with soap and water. Following topical exposure, tingling, burning and redness have been observed. In case of contact with the mucous membranes, these should be flushed thoroughly with water. Upon inhalation, dyspnoea, chest pain, burning throat and nausea have been reported.
If unopened vials are refrigerated, a precipitate may form that redissolves with little or no agitation upon reaching room temperature. Product quality is not affected. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded.
Following multiple needle entries and product withdrawals, the vials maintain microbial, chemical and physical stability for up to 28 days at 25°C. Other in-use storage times and conditions are the responsibility of the user.
Preparation for IV administration: Prior to infusion, paclitaxel must be diluted using aseptic techniques in 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection to a final concentration of 0.3 to 1.2 mg/ml.
Chemical and physical in-use stability of the solution prepared for infusion has been demonstrated at 5°C and at 25°C for 51 hours when diluted in 5% Dextrose solution, and for 51 hours when diluted in 0.9% Sodium Chloride Injection. 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 would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
After dilution the solution is for single use only.
Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle, and is not removed by filtration. Paclitaxel should be administered through an in-line filter with a microporous membrane ≤0.22 μm. No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line filter.
There have been rare reports of precipitation during paclitaxel infusions, usually towards the end of a 24 hour infusion period. Although the cause of this precipitation has not been elucidated, it is probably linked to the supersaturation of the diluted solution. To reduce the precipitation risk, paclitaxel should be used as soon as possible after dilution, and excessive agitation, vibration or shaking should be avoided. The infusion sets should be flushed thoroughly before use. During infusion, the appearance of the solution should be regularly inspected and the infusion should be stopped if precipitation is present.
To minimise patient exposure to DEHP, which may be leached from plasticised PVC infusion bags, sets, or other medical instruments, diluted [Paclitaxel - parenteral dosage form] solutions should be stored in bottles without PVC (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets. Use of filter devices 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.
Incompatibilities: The polyethoxylated castor oil may result in DEHP [di(2-ethylhexyl)phthalate] leaching from plasticised polyvinylchloride (PVC) containers at levels which increase with time and concentration. Consequently, the preparation, storage and administration of diluted paclitaxel should be carried out using non-PVC-containing equipment.
