AHFS Class:

10:00 Antineoplastic Agents

Generic Name

• DOCEtaxel

Several different formulations of docetaxel injection products are available.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹ CAUTION: Care should be taken to ensure that the correct drug product, dose, and preparation procedure are used and that no confusion among differing products and concentrations occurs.

The use of gloves during preparation of docetaxel doses is recommended.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹ If docetaxel concentrate, powder, or any reconstituted or diluted solution comes in contact with skin, the affected area should be washed thoroughly with soap and water.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹ If contact with mucosa occurs, thorough flushing with water is required.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹

Docetaxel concentrate with diluent (2-vial package). Docetaxel concentrate is available in a 2-vial package: the first vial contains docetaxel concentrate 0.5 mL (20 mg) or 2 mL (80 mg), while the second vial contains 1.95 or 7.2 mL, respectively, of the special diluent.³⁰¹⁴ Each mL of docetaxel concentrate in the first vial contains docetaxel (anhydrous) 40 mg, polysorbate 80 1040 mg, and dehydrated alcohol 60 mg.³⁰¹⁴ Citric acid anhydrous also may have been added to adjust the pH.³⁰¹⁴ The diluent vial contains the special diluent, which is composed of polyethylene glycol 400 13% (w/v) in water for injection.³⁰¹⁴ Both the docetaxel vials and the accompanying diluent vials contain an overfill.³⁰¹⁴

Preparation of the final diluted solution for infusion from this 2-vial formulation requires a 2-step dilution procedure prior to administration.³⁰¹⁴ Step 1 is the preparation of the initial diluted solution, which is then further diluted to the final diluted solution for infusion in step 2.³⁰¹⁴

To prepare the initial diluted solution (step 1), the vial of accompanying diluent should be partially inverted to withdraw the entire contents (approximately 1.95 mL for docetaxel 20 mg and approximately 7.2 mL for docetaxel 80 mg) and the contents should be added to the appropriate corresponding vial of docetaxel concentrate.³⁰¹⁴ Using repeated inversions, each vial of diluted docetaxel concentrate should then be thoroughly mixed for about 45 seconds; vials should not be shaken.³⁰¹⁴ This initial diluted solution is a clear solution having a docetaxel concentration of 10 mg/mL.³⁰¹⁴ If foam appears on the surface of the solution from the surfactant (i.e., polysorbate 80) in the formulation, the vials should be allowed to stand until any foam has dissipated; however, it is not necessary for all of the foam to have dissipated before proceeding with the rest of the preparation steps.³⁰¹⁴

To prepare the final diluted solution (step 2), the appropriate dose of the docetaxel 10-mg/mL initial diluted solution should be withdrawn from the vial and added to 250 mL of sodium chloride 0.9% or dextrose 5% in a glass or plastic (e.g., polypropylene, polyolefin) infusion container to produce a final diluted solution for infusion with a concentration of 0.3 to 0.74 mg/mL.³⁰¹⁴ For docetaxel doses exceeding 200 mg, a larger volume of infusion solution should be used so that the concentration of the final diluted solution for infusion does not exceed 0.74 mg/mL.³⁰¹⁴ The final diluted solution for infusion should be thoroughly mixed by rotation.³⁰¹⁴

The manufacturer cautions that the 2-vial and 1-vial formulations of docetaxel concentrate should not be used together.³⁰¹⁴

Docetaxel concentrate (1-vial package). Docetaxel also is available in single-use and multidose 1-vial formulations as concentrates of either 10³⁰¹³ or 20 mg/mL³⁰¹²; ³⁰¹⁴ in polysorbate 80 and dehydrated alcohol.³⁰¹²; ³⁰¹³; ³⁰¹⁴ Anhydrous citric acid,³⁰¹³; ³⁰¹⁴ polyethylene glycol,³⁰¹³ propylene glycol,³⁰¹⁶ edetate disodium,³⁰¹⁶ and povidone³⁰¹⁸ also may be present in some products; specific product labeling should be consulted for additional formulation details.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁸ These concentrates do not require a 2-step dilution process; instead, these concentrates may be added directly to an infusion solution as a single step.³⁰¹²; ³⁰¹³; ³⁰¹⁴

Manufacturer recommendations differ on storage of the various 1-vial formulations;³⁰¹²; ³⁰¹³; ³⁰¹⁴ if stored under refrigeration, the appropriate number of vials should be allowed to stand at room temperature for approximately 5 minutes prior to use.³⁰¹² The appropriate dose of the docetaxel concentrate should be withdrawn from the vials using only a 21-gauge needle;³⁰¹²; ³⁰¹³; ³⁰¹⁴ larger bore needles (e.g., 18- or 19-gauge) may result in coring of the stopper and the presence of rubber particulates.³⁰¹²; ³⁰¹⁴ The dose should be added to 250 mL of sodium chloride 0.9% or dextrose 5% in a glass or plastic (e.g., polypropylene, polyolefin) infusion container to produce a diluted solution for infusion with a docetaxel concentration of 0.3 to 0.74 mg/mL.³⁰¹²; ³⁰¹³; ³⁰¹⁴ For docetaxel doses exceeding 200 mg, a larger volume of infusion solution should be used so that the concentration of the diluted solution for infusion does not exceed 0.74 mg/mL.³⁰¹²; ³⁰¹³; ³⁰¹⁴ The diluted solution for infusion should be thoroughly mixed by gentle manual rotation.³⁰¹²; ³⁰¹³; ³⁰¹⁴

Docetaxel alcohol-free concentrate (1-vial package). An alcohol-free 1-vial formulation of docetaxel 20 mg/mL concentrate also is available for dilution as a single step.³⁰⁹⁹ This formulation is available in 1-mL (20 mg) single-dose vials and 4-mL (80 mg) and 8-mL (160 mg) multidose vials.³⁰⁹⁹ Each mL contains docetaxel (anhydrous) 20 mg, soybean oil 27.5 mg, polysorbate 80 585 mg, citric acid 10 mg, and polyethylene glycol 300 442.2 mg.³⁰⁹⁹ The appropriate dose of the docetaxel injection should be withdrawn from the vials using a 20-gauge needle and transferred to 250 mL of sodium chloride 0.9% or dextrose 5% in a glass or plastic (e.g., polypropylene, polyolefin) infusion container in a single injection to produce a diluted solution for infusion with a concentration of 0.3 to 0.74 mg/mL.³⁰⁹⁹ For docetaxel doses exceeding 200 mg, a larger volume of infusion solution should be used so that the concentration of the diluted solution for infusion does not exceed 0.74 mg/mL.³⁰⁹⁹ The diluted solution for infusion should be thoroughly mixed by gentle manual rotation.³⁰⁹⁹

Docetaxel lyophilized powder with diluent (2-vial package). Docetaxel also is available as a lyophilized powder in a single-use vial containing 20 or 80 mg of docetaxel (anhydrous) packaged with a diluent vial containing approximately 1 or 4 mL of diluent (ethanol 35.4% [w/w] in polysorbate 80).³⁰¹⁵ Both the docetaxel vials and the accompanying diluent vials contain a slight overfill.³⁰¹⁵

To prepare the solution for infusion, the appropriate number of vials of powder and accompanying diluent should be allowed to stand at room temperature for approximately 5 minutes prior to use.³⁰¹⁵ The diluent vials should be partially inverted to withdraw the diluent using an 18- to 21-gauge, 1½-inch needle.³⁰¹⁵ The diluent should be transferred to the powder vial, and the vial should be shaken well to completely dissolve the powder.³⁰¹⁵ The 20-mg vial should be reconstituted with 1 mL of the accompanying diluent to yield a solution containing 20 mg/0.8 mL (equivalent to 25 mg/mL); the 80-mg vial should be reconstituted with 4 mL of the accompanying diluent to yield a solution with a concentration of 24 mg/mL.³⁰¹⁵ If bubbles appear in the solution from the surfactant (i.e., polysorbate 80) in the formulation, the vials should be allowed to stand until any bubbles have dissipated.³⁰¹⁵

The appropriate dose of the docetaxel reconstituted solution should be withdrawn from the vial and added to 250 mL of sodium chloride 0.9% or dextrose 5% in a glass or plastic (e.g., polypropylene, polyolefin) infusion container to produce a final diluted solution for infusion with a concentration of 0.3 to 0.74 mg/mL.³⁰¹⁵ For docetaxel doses exceeding 200 mg, a larger volume of infusion solution should be used so that the concentration of the final diluted solution for infusion does not exceed 0.74 mg/mL.³⁰¹⁵ The final diluted solution for infusion should be thoroughly mixed by manual rotation.³⁰¹⁵

Alcohol Content

Docetaxel injection products differ in the amount of alcohol (ethanol) present in the formulation:³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰¹⁹; ³⁰²⁵; ³⁰⁹⁹

The manufacturers and FDA state that consideration should be given to the alcohol content of docetaxel injection products when prescribing or administering the drug, especially in patients in whom alcohol intake should be avoided or minimized³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰¹⁹ or when used in conjunction with other medications.³⁰¹⁹

Trade Name(s)

Docefrez, Taxotere

Docetaxel is administered as a 1-hour intravenous infusion at ambient temperature and light to patients who have been adequately premedicated to control adverse effects.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵ To minimize patient exposure to the diethylhexyl phthalate (DEHP) plasticizer, the infusion solution should be infused using polyethylene-lined administration sets.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹

All diluted docetaxel solutions for infusion should be visually inspected for particulate matter and discoloration prior to administration; any solution that is not clear or that appears to contain a precipitate should be discarded.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵

Docetaxel concentrate with diluent (2-vial package) is a viscous clear yellow to brownish-yellow solution.³⁰¹⁴ Intact vials of docetaxel with the accompanying special diluent should be stored at controlled room temperature and protected from light.³⁰¹⁴

The manufacturer states that the initial diluted solution is stable for up to 8 hours after preparation when stored under refrigeration or at room temperature.³⁰¹⁴ Thiesen and Kramer evaluated the stability of docetaxel 10-mg/mL initial diluted solution over 28 days at 25 and 4°C.²²⁴² The initial diluted solution remained visually clear with no color change and no docetaxel loss at either temperature.²²⁴²

The manufacturer states that the final diluted solution for infusion is stable for 4 hours, including the 1-hour infusion time, if stored between 2 and 25°C.³⁰¹⁴

Docetaxel concentrate (1-vial package) formulations vary in color from clear, colorless to pale yellow to brownish-yellow.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁷; ³⁰¹⁸ Recommended storage conditions of intact vials also vary; however, most products should be stored between 2 and 25°C in the original container to protect from light.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁷; ³⁰¹⁸ Freezing of the docetaxel concentrate vials does not adversely affect most 1-vial concentrate products.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁷ Multidose vials are stable for up to 28 days from initial vial puncture; however, temperature storage requirements and light protection recommendations during that time vary among products.³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁷ Specific product labeling should be consulted for additional storage and stability details.

The diluted solution prepared from docetaxel concentrate (Taxotere, Sanofi-Aventis) is stable for up to 6 hours, including the 1-hour infusion time, if stored between 2 and 25°C;³⁰¹² diluted solutions prepared from some generic 1-vial concentrate products have been described as stable for up to 4 hours under the same conditions.³⁰¹³; ³⁰¹⁴; ³⁰¹⁶; ³⁰¹⁷; ³⁰¹⁸ In addition, the physical and chemical stability of the diluted solution for infusion in non-polyvinyl chloride (non-PVC) bags has been demonstrated for up to 48 hours for solutions prepared as recommended and stored at 2 to 8°C for certain products.³⁰¹² Specific product labeling should be consulted for additional stability details.

Docetaxel alcohol-free concentrate (1-vial package) is a clear, colorless to yellow viscous solution.³⁰⁹⁹ Intact vials of the drug should be stored at 20 to 25°C in the original package to protect from light.³⁰⁹⁹ Following dilution of the alcohol-free formulation in sodium chloride 0.9% or dextrose 5% for infusion, the solution is stable for 24 hours if stored between 2 and 25°C.³⁰⁹⁹ Multidose vials are stable for up to 28 days from initial vial puncture with multiple needle entries and withdrawals when stored at 2 to 8°C and protected from light.³⁰⁹⁹

Docetaxel lyophilized powder with diluent (2-vial package) is a white powder that forms a clear solution when reconstituted.³⁰¹⁵ Intact vials of the drug and accompanying diluent should be stored at 2 to 8°C in the original package to protect against bright light.³⁰¹⁵ The manufacturer states that the reconstituted solution is stable for up to 8 hours after preparation when stored under refrigeration or at room temperature.³⁰¹⁵ The final diluted solution for infusion is stable for 6 hours, including the 1-hour infusion time, if stored between 2 and 25°C.³⁰¹⁵ Physical and chemical stability of the final diluted solution for infusion in non-PVC bags also has been demonstrated for up to 48 hours for solutions prepared as recommended and stored at 2 to 8°C.³⁰¹⁵

Docetaxel 0.8 mg/mL in sodium chloride 0.9% did not exhibit an antimicrobial effect on Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans inoculated into the solution. Diluted solutions should be stored under refrigeration whenever possible, and the potential for microbiological growth should be considered when assigning expiration periods.²¹⁶⁰

Freezing Solutions

Although freezing is not noted to adversely affect most 1-vial docetaxel concentrate products,³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁶ one manufacturer states that the diluted docetaxel solution for infusion should not be frozen.³⁰¹⁷

Crystallization

Some docetaxel products are supersaturated and may crystallize over time.³⁰¹²; ³⁰¹⁵; ³⁰¹⁶ If crystallization is noted, the drug must no longer be used and should be discarded.³⁰¹²; ³⁰¹⁵; ³⁰¹⁶

Plasticizer Leaching

The surfactant (polysorbate 80) contained in docetaxel formulations can leach plasticizer from DEHP-plasticized PVC containers and administration sets.¹⁶⁸³ The amount of DEHP plasticizer leached is time and concentration dependent;¹⁶⁸³ it is also a function of the lipophilicity of the fluid that comes into contact with the DEHP-plasticized PVC container or device.³¹⁰⁰ The manufacturers recommend that docetaxel not be allowed to contact such containers and equipment.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹ To minimize patient exposure to the plasticizer, the infusion solution should be stored in glass or plastic (e.g., polyolefin, polypropylene) containers and infused using polyethylene-lined administration sets.³⁰¹²; ³⁰¹³; ³⁰¹⁴; ³⁰¹⁵; ³⁰⁹⁹

In 1996, an acceptability limit of no more than 5 parts per million (5 mcg/mL) for DEHP plasticizer leached from PVC-containing devices (e.g., containers) was proposed based on a review of metabolic and toxicologic considerations.²¹⁸⁵ FDA later evaluated the safety of DEHP exposure by comparing doses of DEHP received by patients undergoing various medical procedures with a defined tolerable intake value of DEHP, a value that was based upon the results of selected critical toxicity studies in experimental animals.³¹⁰⁰ Based on the results of the safety assessment, FDA concluded that there is little risk posed by exposure to the amount of DEHP released from PVC bags used to store and administer drugs that require an excipient for solubilization when label instructions for preparation and administration are followed.³¹⁰⁰ However, such conclusions do not take into account increased risk for adverse effects from DEHP exposure in certain patients (e.g., critically ill male neonates or infants, male infants less than 1 year of age, male offspring of pregnant or breast-feeding women undergoing certain medical treatments) or potential adverse effects related to aggregate exposure for patients exposed to multiple medical devices, procedures, or intravenous medications known to leach DEHP, for which there are varying levels of concern.³¹⁰⁰; ³¹⁰¹

Mazzo et al. evaluated the leaching of DEHP plasticizer by docetaxel 0.56 and 0.96 mg/mL in dextrose 5% and in sodium chloride 0.9%. PVC bags of the solutions were used to prepare the admixtures. The leaching of the plasticizer was found to be time and concentration dependent; however, there was little difference between the 2 infusion solutions. After storage for 8 hours at 21°C, leached DEHP was found in the range of 30 to 51 mcg/mL for the 0.96-mg/mL concentration and 25 to 36 mcg/mL for the 0.56-mg/mL concentration. During a simulated 1-hour infusion, the amount of leached DEHP did not exceed 14 mcg/mL.¹⁸²⁵

A study was performed on the compatibility of docetaxel 0.31 and 0.88 mg/mL in dextrose 5% or sodium chloride 0.9% with various infusion sets. The docetaxel solutions were run through the administration sets and the effluent was analyzed for DEHP plasticizer. At the higher concentration of docetaxel tested (0.88 mg/mL), unacceptable amounts of DEHP were leached from the Baxter vented nitroglycerin set (2C7552S), the Baxter vented volumetric pump nitroglycerin set (2C1042), and the IMED standard PVC set (9210). At both the low and high concentrations tested (0.31 and 0.88 mg/mL), unacceptable amounts of DEHP were leached from the IVAC MiniMed Uni-Set microbore (28026) and MiniMed Uni-Set macrobore full set (28034). The sets cited in Table 1 and Table 2 leached little or no DEHP.²⁴⁵¹

In another study, 20 mg of docetaxel (Taxotere, Sanofi-Aventis) was first dissolved in 1 mL of dehydrated alcohol and then diluted in 100 mL of sodium chloride 0.9%.³¹¹⁰ The solution was circulated through an 85-cm length of commercial PVC intravenous infusion tubing (Becton Dickinson) containing 25% DEHP by weight at a rate of 1.2 to 3 mL/min over a period of 1 hour.³¹¹⁰ A decrease in light transmittance was first detected at 30 minutes and precipitation of the drug was noted by 1 hour.³¹¹⁰ Precipitation was thought to be the result of leached DEHP interacting with surfactant (polysorbate 80) molecules in the docetaxel formulation, thereby decreasing the solubility of the drug.³¹¹⁰ This phenomenon was not observed with the use of low-DEHP content (10% by weight) PVC and non-PVC intravenous infusion tubings (Polysciencetech).³¹¹⁰

With use of infusion bags and tubing that are free of DEHP plasticizer and the elimination of PVC precision flow regulators, a reduction in leached DEHP of up to 99% has been reported.²⁶⁷⁹

Docetaxel vehicle equivalent to docetaxel 0.74 mg/mL in dextrose 5% was tested in VISIV polyolefin bags at room temperature near 23°C for 24 hours. No leached plastic components were found within the 24-hour study period.²⁶⁶⁰; ²⁷⁹²

Docetaxel in PVC containers leached 200 to 500 mcg/mL of DEHP in 48 hours when stored under refrigeration and at room temperature, respectively. The use of nonplasticized containers such as polyethylene plastic containers was recommended.²⁷¹⁸

Table 1. Administration Sets Compatible with Docetaxel Infusions at Concentrations of 0.88 mg/mL or Less²⁴⁵¹

Table 2. Extension Sets Compatible with Docetaxel Infusions at Concentrations of 0.88 mg/mL or Less²⁴⁵¹

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.