Handling of Taxotere®
Taxotere® (docetaxel) is supplied in a clear glass vial with a red
flip-off cap for the 80-mg vial and a green cap for the 20-mg vial. Diluent is supplied
in a clear glass vial with a transparent colorless flip-off cap. Both items are
provided in a blister pack in a single carton.1 Each
vial is a single-use vial and should not be used for multiple doses.1
| Taxotere® 80 mg |
80 mg docetaxel per 2 mL polysorbate 80 |
| Diluent (13% ethanol in water for injection) |
6 mL* |
| Taxotere® 20 mg |
20 mg docetaxel per 0.5 mL polysorbate 80 |
| Diluent (13% ethanol in water for injection) |
1.5 mL* |
* Both the Taxotere® Injection Concentrate and the diluent vials contain an overfill
to compensate for liquid loss during preparation. This overfill ensures that after
dilution with entire contents (approximately 1.8 mL for Taxotere
20 mg and approximately 7.1 mL for Taxotere® 80 mg) of the accompanying diluent,
there is an initial diluted solution containing 10 mg/mL docetaxel.1
Handling Precautions
Procedures for proper handling and disposal of anticancer drugs should be considered.
Several guidelines on this subject, such as the following, have been published.
However, there is no general agreement that all of the procedures recommended in
the following guidelines are necessary or appropriate.1–7
- As with all cytotoxic drugs, care should be taken when handling and preparing Taxotere.2
Taxotere® should be prepared in a class II biological safety cabinet using standard
precautions for the safe handling of antineoplastic agents.2,3
Latex gloves are recommended.3 (Please refer to references 2–7 for further
information on the safe handling of antineoplastic agents.2–7)
- If Taxotere® concentrate or solution comes in contact with skin, immediately and
thoroughly wash with soap and water. If contact is made with mucosa, immediately
and thoroughly wash with water. 1,3–6
- The disposal of unwanted Taxotere® solution should follow recommended procedures
for the disposal of anticancer drugs.1
Supplies
The supplies needed for Taxotere® administration include the following8:
| Calibrated syringes |
Use smallest possible syringe and needle (e.g., for a 20-mg vial use a 3-mL syringe and a 19-gauge, 1.5-inch needle) |
Bag/bottle*:
100 mL
250 mL
>250 mL |
Use for doses of:
<80 mg
80 mg–200 mg
>200 mg |
| Administration sets |
Polyethylene-lined administration kits |
* The concentration of the final dilution for infusion should be in the range of
0.3 to 0.74 mg/mL. This calculation includes the volume of the bag/bottle plus the
volume of the drug added.1
NOTE: Filtration of the infusate is not required.
Contact of the undiluted concentrate with plasticized PVC equipment or devices used
to prepare solutions for infusion is not recommended. To minimize patient exposure
to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC
infusion bags or sets, diluted Taxotere® solution should be stored in bottles (glass,
polypropylene) or plastic bags (polypropylene, polyolefin) and administered through
polyethylene-lined administration sets.1
Storage and Stability
- Unopened Taxotere® vials may be stored under refrigeration or at room temperature,
2°C to 25°C (36°F to 77°F). Store in their original package to protect
from bright light.
- Unopened concentrate and diluent vials of Taxotere® are stable until the expiration
date indicated on the package when stored under proper conditions.
- Contact of the Taxotere® concentrate with plasticized PVC equipment or devices used
to prepare solutions for infusion is not recommended.
- Freezing does not adversely affect Taxotere® concentrate.
- Initial diluted solution is stable for up to 8 hours under refrigeration or at room
temperature, at temperatures from 2°C to 25°C (36°F to 77°F).
- Final solution for infusion is stable for up to 4 hours under refrigeration or at
room temperature, at temperatures from 2°C to 25°C (36°F to 77°F).
- Use Taxotere® initial diluted solution and Taxotere® final dilution for infusion as
soon as possible after preparation.1
References
- Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; November 2007.
- American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033–1049.
- Office of Occupational Medicine. Occupational Safety and Health Administration (OSHA). Controlling occupational exposure to hazardous drugs. Am J Health Syst Pharm. 1996;53:1669–1685.
- American Medical Association Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590–1592.
- National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. Available at: http://ctep.cancer.gov/handbook/append_13.html.
- Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. 1983;1:426–428.
- Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258–263.
- Data on file, sanofi-aventis.