Treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Monotherapy of locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
In combination with cisplatin for treatment of unresectable locally advanced or metastatic non-small cell lung cancer in patients who have not previously received chemotherapy for this condition; also used in combination with carboplatin.
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV infusion.
Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., gloves) and wash hands after removal of the gloves.
Immediately treat accidental contact with skin by thoroughly washing with soap and water; immediately treat accidental contact with mucous membranes by thoroughly washing with water.
Administer through polyethylene-lined administration sets. Use of inline filters is neither required nor recommended.
Docetaxel for injection concentrate requires 2 dilutions prior to administration.
Remove vials from refrigerator and allow to stand at room temperature for approximately 5 minutes. Add the contents of the diluent vial to the vial of docetaxel for injection concentrate, to give a solution containing docetaxel 10 mg/mL.
Mix this solution by repeated inversions for at least 45 seconds; do not shake. If foaming occurs, allow solution to stand for a few minutes to allow foam to dissipate; all foam does not have to dissipate to continue preparation.
Withdraw the appropriate dose with a calibrated syringe and inject into 250 mL of either 0.9% sodium chloride injection or 5% dextrose injection to produce a final docetaxel concentration of 0.3–0.74 mg/mL.
If doses larger than 200 mg of docetaxel are required, increase volume of IV solution accordingly so that a docetaxel concentration of 0.74 mg/mL is not exceeded.
Administer over 1 hour.
60–100 mg/m2 in repeated 3-week cycles.
Dosage adjustment during treatment may be necessary. In patients initially dosed at 100 mg/m2 who experience febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or peripheral neuropathy, reduce dose by 25% (e.g., from 100 to 75 mg/m2) for subsequent courses of therapy. If the patient continues to experience these reactions, reduce dosage from 75 to 55 mg/m2 or discontinue. Discontinue entirely if >grade 3 peripheral neuropathy develops.
Higher doses may be tolerated by patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or peripheral neuropathy.
Treatment after failure of platinum-based chemotherapy: 75 mg/m2 in repeated 3-week cycles. Higher doses (i.e., 100 mg/m2) associated with increased hematologic toxicity, infection, and treatment-related mortality.
Chemotherapy-naive patients: 75 mg/m2 immediately followed by cisplatin in repeated 3-week cycles.
Dosage adjustment during treatment may be necessary. In patients who are dosed initially at 75 mg/m2 after failure of platinum-based chemotherapy who experience febrile neutropenia, neutrophil count <500/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or other grade 3/4 nonhematologic toxicities, withhold until toxicity resolves and then resume at 55 mg/m2. Discontinue entirely if >grade 3 peripheral neuropathy develops.
In chemotherapy-naive patients who are dosed initially at 75 mg/m2 in conjunction with cisplatin whose nadir platelet count during the previous course is <25,000/mm3, or who experience febrile neutropenia or serious nonhematologic toxicities, reduce dose to 65 mg/m2 for subsequent cycles. In patients who need further dose reduction, a dose of 50 mg/m2 is recommended.
100 mg/m2.
Not recommended in patients with hepatic impairment. (See Hepatic Impairment under Boxed Warning.)
Dosage adjustment does not appear to be necessary.
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
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