Vexel-30/Vexel-100/Vexel-300 Caution For Usage

Special precautions for disposal and other handling: Handling: Paclitaxel is a cytotoxic anticancer medicinal product and caution should be exercised in handling paclitaxel. Dilution should be carried out under aseptic conditions, by trained personnel in a designated area. Appropriate gloves should be used. Contact of paclitaxel with skin and mucous membranes should be avoided. If paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnoea, chest pain, burning throat, and nausea have been reported.
Preparation for IV administration: During dilution of the concentrate for infusion, cytostatic dispensing needles or similar devices with spikes should not be used with vials of paclitaxel since they can cause the stopper to collapse resulting in loss of sterile integrity of the solution. Prior to infusion, paclitaxel must be diluted to a ready-to-use solution for infusion (0.3 to 1.2 mg/mL) using aseptic techniques with one of the following solutions: 9 mg/mL (0.9%) sodium chloride solution for infusion; 50 mg/mL (5%) glucose solution for infusion; 50 mg/mL glucose and 9 mg/mL sodium chloride solution for infusion; or Ringer's solution containing 50 mg/mL glucose. Once diluted, the ready-to-use infusions are for single use only.
The ready-to-use infusion should be visually inspected for particulate matter and discoloration. Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle, and is not removed by filtration. However haziness does not affect the potency of the product. The solution for infusion should be administered through an in-line filter with microporous membrane not greater than 0.22 microns. No significant losses in potency have been noted following simulated delivery of the solution through I.V. tubing containing an in-line (0.22 micron) filter.
There have been some reports of precipitation during paclitaxel infusions, with precipitation usually taking place towards the end of a 24-hour infusion period. To reduce the risk of precipitation, paclitaxel should be used as soon as possible after dilution and excessive shaking or agitation should be avoided. The infusion solution should be regularly inspected during infusion and the infusion should be discontinued if precipitation occurs. To minimize patient exposure to di-2-ethylhexyl phthalate (DEHP) which may be leached from plasticized PVC infusion bags, sets, or other medical instruments, diluted paclitaxel solutions should be stored in non-PVC bottles (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 plasticized PVC tubing has not resulted in significant leaching of DEHP. The solutions are physically and chemically stable up to 27 hours at ambient temperature 25°C.