Docetaxel

Usual Diluents

NS, D5W,LR.

Reconstitution

Note: Multiple concentrations: Docetaxel is available as a one-vial formulation at

concentrations of 10 mg/mL (generic formulation) and 20 mg/mL (concentrate;

Taxotere, and as a lyophilized powder (Docefrez) which is reconstituted (with

provided diluent) to 20 mg/0.8 mL (20 mg vial) or 24 mg/mL (80 mg vial).

Admixture errors have occurred due to the availability of various concentrations.

Docetaxel was previously available as a two-vial formulation which included two

vials (a concentrated docetaxel vial and a diluent vial), resulting in a reconstituted

concentration of 10 mg/mL; the two-vial formulation has been discontinued by the

manufacturer.

One-vial formulations: Further dilute for infusion in 250-500 mL of NS or D5W in a

non-DEHP container (eg, glass, polypropylene, polyolefin) to a final concentration of

0.3-0.74 mg/mL. Gently rotate and invert manually to mix thoroughly; avoid shaking

or vigorous agitation. Note: For docetaxel injection concentrate 20 mg/mL

(Taxotere), use only a 21 gauge needle to withdraw docetaxel from the vial (larger

bore needles, such as 18 gauge or 19 gauge needles may cause stopper coring and

rubber precipitates).

Lyophilized powder: Dilute with the provided diluent (contains ethanol in

polysorbate 80); add 1 mL to each 20 mg vial (resulting concentration is 20 mg/0.8

mL) and 4 mL to each 80 mg vial (resulting concentration is 24 mg/mL). Shake well

to dissolve completely. If air bubbles are present, allow to stand for a few minutes

while air bubbles dissipate. Further dilute in 250 mL of NS or D5W in a non-DEHP

container (eg, glass, polypropylene, polyolefin) to a final concentration of 0.3-0.74

mg/mL (for doses >200 mg, use a larger volume of NS or D5W, not to exceed a final

concentration of 0.74 mg/mL). Mix thoroughly by manual agitation. Solutions diluted

for infusion should be used within 4 hours of preparation, including infusion time.

Two-vial formulation (discontinued product): Vials should be diluted with 13%

(w/w) ethanol/water (provided with the drug) to a final concentration of 10 mg/mL.

Do not shake. Further dilute for infusion in 250-500 mL of NS or D5W in a non-

DEHP container (eg, glass, polypropylene, polyolefin) to a final concentration of 0.3-

0.74 mg/mL. Gently rotate to mix thoroughly. Do not use the two-vial formulation

with the one-vial formulation for the same admixture product.

Standard Dilution

[ Initial Diluted Solution

1. 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 and diluent (13% ethanol in water for

injection) vials to stand at room temperature for approximately 5 minutes.

2. Aseptically withdraw the entire contents of the appropriate diluent vial

(approximately 1.8 mL for TAXOTERE 20 mg and approximately 7.1 mL for

TAXOTERE 80 mg) into a syringe by partially inverting the vial, and transfer

it to the appropriate vial of TAXOTERE Injection Concentrate. If the

procedure is followed as described, an initial diluted solution of 10 mg

docetaxel/mL will result.

3. Mix the initial diluted solution by repeated inversions for at least 45 seconds

to assure full mixture of the concentrate and diluent. Do not shake.

4. The initial diluted TAXOTERE solution (10 mg docetaxel/mL) should be

clear; however, there may be some foam on top of the solution due to the

polysorbate 80. Allow the solution to stand for a few minutes to allow any

foam to dissipate. It is not required that all foam dissipate prior to continuing

the preparation process.

The initial diluted solution may be used immediately or stored either in the

refrigerator or at room temperature for a maximum of 8 hours.

B. Final Dilution for Infusion

1. Aseptically withdraw the required amount of initial diluted TAXOTERE

solution (10 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 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.

2. Thoroughly mix the infusion by manual rotation.

3. 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 initial diluted solution or

final dilution for intravenous infusion is not clear or appears to have

precipitation, these should be discarded.

The final TAXOTERE dilution for infusion should be administered intravenously as a

1-hour infusion under ambient room temperature and lighting conditions.

Stability / Miscellaneous

Docetaxel 10 mg/mL: Store intact vials between 2°C to 25°C (36°F to 77°F)

(actual recommendations may vary by generic manufacturer; consult

manufacturer’s labeling). Protect from bright light. Freezing does not

adversely affect the product. Multi-use vials (80 mg/8 mL and 160 mg/16 mL)

are stable for up to 28 days after first entry when stored between 2°C to 8°C

(36°F to 46°F) and protected from light.

Docetaxel concentrate (Taxotere) 20 mg/mL: Store intact vials between 2°C to

25°C (36°F to 77°F). Protect from bright light. Freezing does not adversely

affect the product.

Docetaxel lyophilized powder (Docefrez): Store intact vials between 2°C to

8°C (36°F to 46°F). Protect from light. Allow vials (and provided diluent) to

stand at room temperature for 5 minutes prior to reconstitution. After

reconstitution, may be stored refrigerated or at room temperature for up to 8

hours.

Solutions diluted for infusion should be used within 4 hours of preparation,

including infusion time.

Two-vial formulation (discontinued product): Reconstituted solutions of the

two-vial formulation are stable in the vial for 8 hours at room temperature or

under refrigeration. Solutions diluted for infusion in polyolefin containers

should be used within 4 hours of preparation, including infusion time.