Docetaxel

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Docetaxel

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  • For more information please contact customBOXED WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTIONer care:

    • Treatment-related mortality increases with abnormal liver func on, at higher doses, and in pa ents with NSCLC and prior pla num- based therapy receiving Docetaxel at 100 mg /m2.
    • Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT eleva ons increase risk of severe or life-threatening complica ons. Obtain LFTs
    • before each treatment cycle.
    • Should not be given if neutrophil counts are < 1500 cells/mm . Obtain frequent blood counts to monitor for neutropenia.
    • Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in pa ents who received dexamethasone premedica on. Severe reac ons require immediate discon nua on of Docetaxel and administra on of appropriate therapy.
    • Contraindicated if history of severe hypersensi vity reac ons to Docetaxel or to drugs formulated with polysorbate 80.
    • Severe uid reten on may occur despite dexamethasone.

    1 INDICATIONS AND USAGE

    Docetaxel is a microtubule inhibitor indicated for:

    1.1.Breast Cancer (BC):

    Single agent for locally advanced or metasta c BC a er chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node- posi ve BC.

    1.2. Non-Small Cell Lung Cancer (NSCLC):

    Single agent for locally advanced or metasta c NSCLC a er pla num therapy failure; and with cispla n for unresectable, locally advanced or metasta c untreated NSCLC.

    1.3. Hormone Refractory Prostate Cancer (HRPC):

    With prednisone in androgen independent (hormone refractory) metasta c prostate cancer.

    1.4. Gastric Adenocarcinoma (GC):

    With cispla n and uorouracil for untreated, advanced GC, including the gastroesophageal junc on.

    1.5. Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN):

    With cispla n and uorouracil for induc on treatment of locally advanced SCCHN.

    2 INDICATIONS AND USAGE

    20 mg/mL single use vial

    80 mg/4 mL single use viald premedica on regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Docetaxel Injec on infusion.

    3 CONTRAINDICATIONS

    • Docetaxel Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
    • Docetaxel Injection should not be used in patients with neutrophil counts of <1500 cells/mm3.
  • For more information please contact customBOXED WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTIONer care:

    • Treatment-related mortality increases with abnormal liver func on, at higher doses, and in pa ents with NSCLC and prior pla num- based therapy receiving Docetaxel at 100 mg /m2.
    • Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT eleva ons increase risk of severe or life-threatening complica ons. Obtain LFTs
    • before each treatment cycle.
    • Should not be given if neutrophil counts are < 1500 cells/mm . Obtain frequent blood counts to monitor for neutropenia.
    • Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in pa ents who received dexamethasone premedica on. Severe reac ons require immediate discon nua on of Docetaxel and administra on of appropriate therapy.
    • Contraindicated if history of severe hypersensi vity reac ons to Docetaxel or to drugs formulated with polysorbate 80.
    • Severe uid reten on may occur despite dexamethasone.

    1 INDICATIONS AND USAGE

    Docetaxel is a microtubule inhibitor indicated for:

    1.1.Breast Cancer (BC):

    Single agent for locally advanced or metasta c BC a er chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node- posi ve BC.

    1.2. Non-Small Cell Lung Cancer (NSCLC):

    Single agent for locally advanced or metasta c NSCLC a er pla num therapy failure; and with cispla n for unresectable, locally advanced or metasta c untreated NSCLC.

    1.3. Hormone Refractory Prostate Cancer (HRPC):

    With prednisone in androgen independent (hormone refractory) metasta c prostate cancer.

    1.4. Gastric Adenocarcinoma (GC):

    With cispla n and uorouracil for untreated, advanced GC, including the gastroesophageal junc on.

    1.5. Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN):

    With cispla n and uorouracil for induc on treatment of locally advanced SCCHN.

    2 INDICATIONS AND USAGE

    20 mg/mL single use vial

    80 mg/4 mL single use viald premedica on regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Docetaxel Injec on infusion.

    3 CONTRAINDICATIONS

    • Docetaxel Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred
    • Docetaxel Injection should not be used in patients with neutrophil counts of <1500 cells/mm3.
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