Docetaxel (Page 3 of 12)

2.8 Administration Precautions

Docetaxel Injection is a cytotoxic anticancer drug. Follow special handling and disposal procedures when preparing Docetaxel Injection solutions. 1

If Docetaxel Injection, initial diluted solution, or final dilution for infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If Docetaxel Injection, initial diluted solution, or final dilution for infusion should come into contact with mucosa, immediately and thoroughly wash with water.

Contact of the Docetaxel Injection with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final Docetaxel Injection dilution for infusion should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

Two-vial formulation (Injection with Diluent)

Docetaxel Injection requires two dilutions prior to administration. Please follow the preparation instructions provided below. Note: Both the Docetaxel Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the entire contents of the accompanying diluent, there is an initial diluted solution containing 10 mg/mL docetaxel.

The table below provides the fill range of the Diluent, the approximate extractable volume of Diluent when the entire contents of the diluent vial are withdrawn, and the concentration of the initial diluted solution for Docetaxel Injection 20 mg and Docetaxel Injection 80 mg (see Table 3).

Table 3 – Initial Dilution of Docetaxel Injection
Product Diluent 13% (w/v) polyethylene glycol 400 in water for injection Fill Range (mL) Approximate extractable volume of Diluent when entire contents are withdrawn (mL) Concentration of the initial diluted solution (mg/mL docetaxel)

Docetaxel Injection 20 mg/0.5 mL

1.5 to 2.08 mL

1.95 mL

10 mg/mL

Docetaxel Injection 80 mg/2 mL

6 to 7.4 mL

7.2 mL

10 mg/mL

One-vial formulation (Injection)

Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.

Please follow the preparation instructions provided below.

2.9 Preparation and Administration

DO NOT use the two-vial formulation (Injection with diluent) with the one-vial formulation.

Two-vial formulation (Injection with Diluent)

A.Initial Diluted Solution

1.
Docetaxel Injection vials should be stored at 25°C (77° F) or room temperature; excursions permitted from 15°C — 30°C (59°-86°F) [see USP Controlled Room Temperature], with protection from light.
2.
Aseptically withdraw the entire contents of the appropriate diluent vial (approximately 1.95 mL for Docetaxel Injection 20 mg and approximately 7.2 mL for Docetaxel Injection 80 mg) into a syringe by partially inverting the vial, and transfer it to the appropriate vial of Docetaxel Injection. 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 Docetaxel Injection and diluent. Do not shake.
4.
The initial diluted Docetaxel Injection 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 Docetaxel Injection 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 > 200 mg of Docetaxel Injection is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL Docetaxel Injection is not exceeded.
2.
Thoroughly mix the infusion by manual rotation.
3.
As with all parenteral products, Docetaxel Injection should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the Docetaxel Injection initial diluted solution or final dilution for intravenous infusion is not clear or appears to have precipitation, these should be discarded.
The final Docetaxel Injection dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature and lighting conditions.

One-vial formulation (Injection)

Docetaxel Injection (20 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution. Use only a 21 gauge needle to withdraw docetaxel from the vial because larger bore needles (e.g., 18 and 19 gauge) may result in stopper coring and rubber particulates.

1.
Docetaxel Injection vials should be stored between 15°C and 25°C (59°F and 77°F).
2.
Using only a 21 gauge needle, aseptically withdraw the required amount of Docetaxel Injection (20 mg docetaxel/mL) with a calibrated syringe and inject via a single injection 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 > 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL docetaxel is not exceeded
3.
Thoroughly mix the infusion by gentle manual rotation.
4.
As with all parenteral products, docetaxel should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the docetaxel dilution for intravenous infusion is not clear or appears to have precipitation, it should be discarded.
5.
Docetaxel Injection infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.

The docetaxel dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature (below 25°C) and lighting conditions.

2.10 Stability

Docetaxel Injection final dilution for infusion, if stored between 2°C and 25°C (36°F and 77°F) is stable for 4 hours. Docetaxel Injection 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).

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