• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Docetaxel Hospira
    / Pfizer


    Active Ingredient
    Docetaxel 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    2 ml X 10 mg/ml

    partial basket chart 41882 4636

    Solution for Infusion

    8 ml X 10 mg/ml

    partial basket chart 41876 4594

    Solution for Infusion

    16 ml X 10 mg/ml

    partial basket chart 41883 4596

    Dosage

    Recommended dosage: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used. Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
    For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours and 1 hour before the docetaxel infusion. Docetaxel is administered as a one-hour infusion every three weeks.
    See prescribing information for full details.


    Indications

    Breast cancer: In combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable node-positive breast cancer. In combination with doxorubicin for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Monotherapy for the treatment of patients with metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. In combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease. In combination with capecitabine for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (AC-TH) for the adjuvant treatment of patients with HER2 overexpressing, node-positive or high risk node-negative, breast cancer. In combination with trastuzumab, and carboplatin (TCH) for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer.
    Non-small cell lung cancer: Treatment of patients with advanced non-small cell lung carcinoma.
    Ovarian cancer: Treatment of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy.
    Prostate cancer: In combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer. Esophageal cancer: Treatment of esophageal cancer.
    Gastric cancer: Treatment of advanced gastric cancer.
    Head and neck (SCCHN): Monotherapy in the treatment of patients with recurrent and/or metastasis squamous cell carcinoma of the head and neck after failure of a previous chemotherapy regimen. In combination with cisplatin and 5 fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.


    Contra-Indications

    – Hypersensitivity to the active substance or to any of the excipients, or to other drugs formulated with polysorbate 80. Severe reactions, including
    anaphylaxis, have occurred.
    – Patients with baseline neutrophil count of <1,500 cells/mm³
    – Severe liver impairment since there is no data available.
    Contraindications for other medicinal products also apply when combined with docetaxel.


    Special Precautions

    Should only be used in specialized departments of oncology and administered under the supervision of an experienced oncologist.
    See prescribing information for full details.


    Side Effects

    The most commonly reported adverse reactions of docetaxel alone are: neutropenia, anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia. The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
    See prescribing information for full details.


    Drug interactions

    In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporin, terfenadine, ketoconazole, erythromycin and troleandomycin. As a result, caution should be exercised when treating patients with these drugs as concomitant therapy since there is a potential for a significant interaction.
    In case of combination with CYP3A4 inhibitors, the occurrence of docetaxel adverse reactions may increase, as a result of reduced metabolism. If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor. In a pharmacokinetic study with 7 patients, the co-administration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by 49%.
    Docetaxel is highly protein-bound (>95%). Although the possible in vivo interaction of docetaxel with concomitantly administered medication has not been investigated formally, in vitro interactions with tightly protein-bound drugs such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel. In addition, dexamethasone did not affect protein binding of docetaxel. Docetaxel did not influence the binding of digitoxin.
    The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration. Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin. When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
    Docetaxel pharmacokinetics in the presence of prednisone has been studied in patients with metastatic prostate cancer. Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4. No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.


    Pregnancy and Lactation

    Pregnancy: There is no information on the use of docetaxel in pregnant women. Docetaxel has been shown docetaxel to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats. As with other cytotoxic medical products docetaxel may cause foetal harm when administered to pregnant women. Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
    Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
    Breast -feeding: Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk. Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding must be discontinued for the duration of docetaxel therapy.


    Overdose

    There were a few reports of overdose. There is no known antidote for docetaxel overdose.
    In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In cases of overdose, exacerbation of adverse events may be expected.
    The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.


    Manufacturer
    Hospira Inc.
    CLOSE