Docetaxel
Dosing in kidney impairment
Grade 3: Discontinue treatment. Ototoxicity: In the case of grade 3 toxicity, discontinue treatment. Nephrotoxicity: In the event of a rise in serum creatinine ≥ grade 2 (>1.5 x normal value) despite adequate rehydration, CrCl should be determined before each subsequent cycle and the following dose reductions should be considered (see Table 2).
| CrCl = Creatinine clearance | |
| Creatinine Clearance Result Before Next Cycle | Cisplatin Dose Next Cycle |
| CrCl ≥ 60 mL/min | Full dose of cisplatin was given. CrCl was to be repeated before each treatment cycle. |
| CrCl between 40 and 59 mL/min | Dose of cisplatin was reduced by 50% at subsequent cycle. If CrCl was > 60 mL/min at end of cycle, full cisplatin dose was reinstituted at the next cycle. If no recovery was observed, then cisplatin was omitted from the next treatment cycle. |
| CrCl < 40 mL/min | Dose of cisplatin was omitted in that treatment cycle only. If CrCl was still < 40 mL/min at the end of cycle, cisplatin was discontinued. If CrCl was > 40 and < 60 mL/min at end of cycle, a 50% cisplatin dose was given at the next cycle. If CrCl was > 60 mL/min at end of cycle, full cisplatin dose was given at next cycle. |
Dosing in liver impairment
Hepatic Impairment Avoid docetaxel injection in patients with bilirubin > ULN and patients with AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN [ see Boxed Warning , Warnings and Precautions , Clinical Pharmacology ] . The alcohol content of docetaxel injection should be taken into account when given to patients with hepatic impairment [see Warnings and Precautions ] .
Preparation and administration
Administration Precautions Docetaxel injection is a hazardous anticancer drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing docetaxel injection solutions. The use of gloves is recommended [see How Supplied/Storage and Handling ] . If docetaxel injection or final dilution for infusion should come into contact with the skin, immediately and thoroughly wash with soap and water.
If docetaxel injection 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.
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.
Preparation and Administration Docetaxel injection (10 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 injection from the vial because larger bore needles (e.g., 18 and 19 gauge) may result in stopper coring and rubber particulates.
Dilution for Infusion 1. Docetaxel Injection unopened vials should be stored between 20° and 25°C (68° and 77°F). After first use and following multiple needle entries and product withdrawals, docetaxel injection multiple-dose vials should be stored between 2° and 8°C (36° and 46°F). If the vials are stored under refrigeration, allow the appropriate number of vials of docetaxel injection vials to stand at room temperature for approximately 5 minutes before use. 2.
Using only a 21 gauge needle, aseptically withdraw the required amount of docetaxel injection (10 mg docetaxel/mL) with a calibrated syringe and inject via a single injection (one shot) 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 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 injection should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit.
If the docetaxel injection 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 injection dilution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature (below 25°C) and lighting conditions.
Stability Docetaxel injection final dilution for infusion, if stored between 2° and 25°C (36° 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).