Albumin-bound paclitaxel is available as a white to yellow lyophilized powder or cake in single-use vials.3219 Each vial contains 100 mg of paclitaxel formulated as albumin-bound nanoparticles (mean particle size of approximately 130 nm).3219 Each vial contains human albumin 900 mg with sodium caprylate and sodium acetyltryptophanate.3219
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs. Albumin-bound paclitaxel should not be substituted for or with other paclitaxel formulations.3219
The lyophilized powder or cake should be reconstituted by slowly (over at least 1 minute) injecting 20 mL of sodium chloride 0.9%, directing the stream of diluent onto the inside wall of the vial.3219 The diluent should not be injected directly onto the lyophilized powder or cake as this will result in foaming.3219 After injection of the full volume of the diluent, the vial should be allowed to stand for at least 5 minutes to ensure proper wetting of the powder or cake, after which point the vial should be gently swirled and/or inverted slowly for at least 2 minutes until complete powder or cake dissolution has occurred.3219 Foam generation should be avoided; if foaming or clumping occurs, the reconstituted suspension should stand for at least 15 minutes until the foaming subsides.3219
The reconstituted albumin-bound paclitaxel suspension should be milky, homogenous, and free of visible particulates.3219 If particulates are visible or settling occurs, the vial should be inverted gently again to ensure resuspension prior to use.3219 If precipitates are observed, the suspension should be discarded.3219
Each mL of the reconstituted suspension contains 5 mg of paclitaxel.3219 The appropriate dose of the drug should be withdrawn from the vial and injected into an empty plasticized polyvinyl chloride (PVC) container or a PVC or non-PVC type intravenous bag.3219
The use of medical devices (e.g., syringes, intravenous bags) containing silicone oil as a lubricant in the preparation and administration of albumin-bound paclitaxel may result in the formation of proteinaceous strands.3219 Following transfer of the reconstituted suspension into the intravenous bag, the suspension should be visually inspected prior to administration; the suspension should be discarded if proteinaceous strands have formed or if particulate matter or discoloration is observed.3219
Trade Name(s)
Abraxane
Albumin-bound paclitaxel suspension is administered by intravenous infusion over 30 or 30 to 40 minutes, depending upon the indication.3219 The manufacturer states that limiting the infusion time to 30 minutes reduces the possibility of infusion-related reactions.3219
Extravasation of albumin-bound paclitaxel has been reported.3219 The infusion site should be monitored closely for possible infiltration during administration.3219
As with other toxic drugs, caution should be exercised in the handling of albumin-bound paclitaxel.3219 Manufacturers recommend the use of gloves.3219 If skin contact with the lyophilized powder or cake or the reconstituted suspension occurs, the affected area(s) should be washed immediately and thoroughly with soap and water since tingling, burning, and redness may occur following topical exposure; for mucosal membrane contact, the affected area(s) should be flushed thoroughly with water.3219 Procedures for the proper disposal of albumin-bound paclitaxel should be considered.3219
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
Intact vials should be stored at 20 to 25°C in the original package to protect from bright light; neither freezing nor refrigeration of the vials is noted to adversely affect stability.3219
Reconstituted albumin-bound paclitaxel suspension prepared in the vial should be used immediately, but may be stored for a maximum of 24 hours at 2 to 8°C when replaced in the original carton to protect from bright light.3219 Reconstituted albumin-bound paclitaxel suspension transferred to an infusion bag also should be used immediately, but may be stored for a maximum of 24 hours at 2 to 8°C when protected from bright light.3219 The time after reconstitution in the vial and after transfer to an infusion bag together should not exceed a combined time of 24 hours at 2 to 8°C; however, this refrigerated storage time may be followed by additional storage of the infusion bag at ambient temperature (approximately 25°C) and lighting conditions for a maximum of 4 hours.3219
Vials are for single use only; unused portions should be discarded.3219
Plasticizer Leaching
Use of diethylhexyl phthalate (DEHP)-free containers or administration sets is not required for the preparation or administration of albumin-bound paclitaxel suspension.3219
For a list of references cited in the text of this monograph, search the monograph titled References.