Docetax Dosage/Direction for Use

Patients receiving docetaxel should be under the supervision of a physician experienced in the use of chemotherapeutic agents.
Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Premedication Regimen: Premedicate all patients (see as follows for prostate cancer) with oral corticosteroids such as dexamethasone 16 mg per day (8 mg twice daily) for 3 days starting one day before docetaxel administration in order to reduce the incidence and severity of fluid retention and hypersensitivity reactions. Antihistamines have not been shown to be useful in controlling fluid retention.
Prostate Cancer Patients: The pretreatment regimen for hormone-refractory metastatic prostate cancer (given the concurrent use of prednisone or prednisolone) is dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour before docetaxel infusion.
General Dosing Information: Diluted docetaxel solution should be administered as a one-hour IV infusion under ambient temperature and lighting conditions.
Spilling of the solution during docetaxel IV infusion can cause irritation, local tissue necrosis, and/or thrombophlebitis. Immediately interrupt docetaxel administration and administer the remaining dose in another vein if extravasation occurs.
Other Dosing Consideration: Prophylactic Use of Granulocyte-Colony Stimulating Factor (G-CSF): Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities. In addition to G-CSF, the prophylactic use of antibiotics may provide additional benefit.
Recommended Docetaxel Dose: See Table 1.

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Dose Adjustments: During Treatment: General: Administer docetaxel therapy when neutrophil count is ≥1,500 cells/mm³.
Reduce docetaxel dose from 100 mg/m² to 75 mg/m² and/or 75 mg/m² to 60 mg/m² in patients who develop either febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy.
If the patient continues to experience these reactions at 60 mg/m², docetaxel therapy should be discontinued.
Breast Cancer: Patients who are dosed initially at 100 mg/m² and who experience either febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, or severe or cumulative cutaneous reactions during docetaxel therapy should have the dosage adjusted from 100 mg/m² to 75 mg/m². If the patient continues to experience these reactions, the dosage should either be decreased from 75 mg/m² to 55 mg/m² or the treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m² and who do not experience febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during docetaxel therapy, may tolerate higher doses. Patients who develop ≥ grade 3 peripheral neuropathy should have docetaxel treatment discontinued entirely.
Combination therapy with docetaxel in the adjuvant treatment of breast cancer: Docetaxel in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mm³. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their docetaxel dose reduced to 60 mg/m². Patients who experience grade 3 or 4 stomatitis should have their docetaxel dose decreased to 60 mg/m². Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have their dosage of docetaxel reduced from 75 to 60 mg/m². If the patient continues to experience these reactions at 60 mg/m², treatment should be discontinued.
Docetaxel in combination with capecitabine: See Table 2.

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Non-small Cell Lung Cancer: Monotherapy with docetaxel for NSCLC treatment after failure of prior platinum-based chemotherapy: Patients who are dosed initially at 75 mg/m² and who experience either febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, severe or cumulative cutaneous reactions, or other grade 3/4 non-hematological toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m². Patients who develop ≥ grade 3 peripheral neuropathy should have docetaxel treatment discontinued entirely.
Combination therapy with docetaxel for chemotherapy-naive NSCLC: For patients who are dosed initially at docetaxel 75 mg/m² in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm³, in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the docetaxel dosage in subsequent cycles should be reduced to 65 mg/m². In patients who require a further dose reduction, a dose of 50 mg/m² is recommended. For cisplatin dosage adjustments, see product's labeling information.
Prostate Cancer: Combination therapy with docetaxel for hormone-refractory metastatic prostate cancer: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm³. For patients who experience either febrile neutropenia, neutrophils <500 cells/mm³ for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have the dosage of docetaxel reduced from 75 to 60 mg/m². Treatment should be discontinued if the patient continues to experience these reactions at 60 mg/m².
Gastric or Head and Neck Carcinoma: Docetaxel in combination with cisplatin and fluorouracil in gastric cancer or head and neck cancer: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m². If subsequent episodes of complicated neutropenia occur, docetaxel dose should be reduced from 60 to 45 mg/m². In case of grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 to 60 mg/m². Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm³ and platelets recover to a level >100,000 cells/mm³. Discontinue treatment if these toxicities persist. (See Table 3.)

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Special Populations: Patients with Hepatic Impairment: Adjust doses based on levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) as indicated in the Table 4: See Table 4.

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Use in the Elderly: No special dose adjustment is recommended. In combination with capecitabine, capecitabine dose should be reduced (For capecitabine dosage adjustments, see product's labeling information).