Taxotere® (docetaxel) Injection Concentrate: Preparation and Administration
DO NOT use the two-vial formulation (Injection Concentrate and diluent) with
the one-vial formulation.
1-vial Taxotere® (docetaxel) Injection Concentrate requires NO
prior dilution with a diluent and is ready to add to the infusion solution.
- TAXOTERE vials should be stored between 2 and 25°C (36 and 77°F). If the vials are
stored under refrigeration, allow the appropriate number of vials of TAXOTERE Injection
Concentrate vials to stand at room temperature for approximately 5 minutes before
use.
- Aseptically withdraw the required amount of TAXOTERE injection concentrate (20 mg
docetaxel/ mL) with a calibrated syringe and inject into a 250 mL infusion bag or
bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce
a final concentration of 0.3 mg/mL to 0.74 mg/mL.
If a dose greater than 200 mg of TAXOTERE is required, use a larger volume of the
infusion vehicle so that a concentration of 0.74 mg/mL TAXOTERE is not exceeded.
- Thoroughly mix the infusion by gentle manual rotation.
- As with all parenteral products, TAXOTERE should be inspected visually for particulate
matter or discoloration prior to administration whenever the solution and container
permit. If the TAXOTERE dilution for intravenous infusion is not clear or appears
to have precipitation, it should be discarded.
The TAXOTERE dilution for infusion should be administered intravenously as a 1-hour
infusion under ambient room temperature (below 25°C) and lighting conditions.
1-vial Taxotere® Injection Concentrate is a sterile, non-pyrogenic,
pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL of 1-vial
Taxotere® contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate
80 and 0.395 grams dehydrated alcohol solution.1
Taxotere® is supplied in a single use clear glass vial with a red
flip-off cap for the 80-mg vial and a green cap for the 20-mg vial. Each vial is
provided in a blister pack in a single carton.1
Contact of the Taxotere 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, the final Taxotere® dilution for infusion
should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene,
polyolefin) and administered through polyethylene-lined administration sets.1
Stability
TAXOTERE final dilution for infusion, if stored between 2°C and 25°C (36°F and 77°F)
is stable for 4 hours. TAXOTERE final dilution for infusion (in either 0.9% Sodium
Chloride solution or 5% Dextrose solution) should be used within 4 hours (including
the 1 hour intravenous administration).
Taxotere® Dosage Forms and Strengths
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Each vial is a single-use vial and should not be used for multiple doses
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Strength
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Labeled fill
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Taxotere® 80 mg
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4 mL concentratea
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Taxotere® 20 mg
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1 mL concentratea
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a Each mL of 1-vial Taxotere® contains 20 mg of docetaxel
in 50/50 (v/v) ratio of polysorbate 80 to dehydrated alcohol.
Taxotere®: Important information about preparation1
Please note the following important information about Taxotere® preparation:
- DO NOT use the 2-vial formulation (injection concentrate and diluent) with
the 1-vial formulation
- Each vial is a single-dose vial and should not be used for multiple doses
- Opened vials may be used immediately or stored either in the refrigerator or at
room temperature for a maximum of 4 hours
- If vials are refrigerated, allow the appropriate number of Taxotere®
vials to stand at room temperature for approximately 5 minutes before use
- Taxotere® should be visually inspected prior to use. Solutions containing
any precipitate or particulate matter must not be used
- Fully prepared infusion solution should be used within 4 hours (including the 1
hour IV administration)