- Breast cancer
- Colorectal and other GI cancers
- Head and neck cancer
- Prostate and other male cancers
- Respiratory and thoracic cancers
Breast cancer:
Indications for: TAXOTERE
Locally advanced or metastatic breast cancer after failure of prior chemotherapy. In combination with doxorubicin and cyclophosphamide: adjuvant treatment of operable node (+) breast cancer.
Adult Dosage:
Give by IV infusion over 1hr once every 3 weeks. Breast cancer: 60–100mg/m2. Adjuvant in operable node (+) breast cancer (treat for 6 courses): 75mg/m2. Premedicate with oral corticosteroid. Adjust dose based on tolerability and effect (see full labeling); allow neutrophils and platelets to recover before subsequent cycles.
Children Dosage:
Not established.
TAXOTERE Contraindications:
Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.
Boxed Warning:
Toxic deaths. Hepatotoxicity. Neutropenia. Hypersensitivity reactions. Fluid retention.
TAXOTERE Warnings/Precautions:
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
TAXOTERE Classification:
Antimicrotubule agent.
TAXOTERE Interactions:
Avoid or minimize alcohol intake. May be affected by CYP3A4 inhibitors, inducers, or substrates. Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole); if co-administration necessary, consider dose reduction by 50%.
Adverse Reactions:
Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, myalgia; hepatotoxicity, death (septic and nonseptic), cystoid macular edema, severe cutaneous reactions (eg, SJS, TEN, AGEP), alcohol intoxication, enterocolitis and neutropenic colitis.
Drug Elimination:
Fecal (80%), renal. Mean terminal half-life: 116 hours.
How Supplied:
Single-dose vial (1mL, 4mL)—1
Colorectal and other GI cancers:
Indications for: TAXOTERE
In combination with cisplatin and fluorouracil: advanced gastric adenocarcinoma without previous chemotherapy.
Adult Dosage:
Give by IV infusion over 1hr once every 3 weeks. 75mg/m2. Premedicate with oral corticosteroid. Adjust dose based on tolerability and effect (see full labeling); allow neutrophils and platelets to recover before subsequent cycles.
Children Dosage:
Not established.
TAXOTERE Contraindications:
Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.
Boxed Warning:
Toxic deaths. Hepatotoxicity. Neutropenia. Hypersensitivity reactions. Fluid retention.
TAXOTERE Warnings/Precautions:
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
TAXOTERE Classification:
Antimicrotubule agent.
TAXOTERE Interactions:
Avoid or minimize alcohol intake. May be affected by CYP3A4 inhibitors, inducers, or substrates. Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole); if co-administration necessary, consider dose reduction by 50%.
Adverse Reactions:
Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, myalgia; hepatotoxicity, death (septic and nonseptic), cystoid macular edema, severe cutaneous reactions (eg, SJS, TEN, AGEP), alcohol intoxication, enterocolitis and neutropenic colitis.
Drug Elimination:
Fecal (80%), renal. Mean terminal half-life: 116 hours.
How Supplied:
Single-dose vial (1mL, 4mL)—1
Head and neck cancer:
Indications for: TAXOTERE
In combination with cisplatin and fluorouracil: induction treatment of locally advanced squamous cell carcinoma of the head and neck.
Adult Dosage:
Give by IV infusion over 1hr once every 3 weeks. 75mg/m2. Premedicate with oral corticosteroid. Adjust dose based on tolerability and effect (see full labeling); allow neutrophils and platelets to recover before subsequent cycles.
Children Dosage:
Not established.
TAXOTERE Contraindications:
Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.
Boxed Warning:
Toxic deaths. Hepatotoxicity. Neutropenia. Hypersensitivity reactions. Fluid retention.
TAXOTERE Warnings/Precautions:
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
TAXOTERE Classification:
Antimicrotubule agent.
TAXOTERE Interactions:
Avoid or minimize alcohol intake. May be affected by CYP3A4 inhibitors, inducers, or substrates. Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole); if co-administration necessary, consider dose reduction by 50%.
Adverse Reactions:
Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, myalgia; hepatotoxicity, death (septic and nonseptic), cystoid macular edema, severe cutaneous reactions (eg, SJS, TEN, AGEP), alcohol intoxication, enterocolitis and neutropenic colitis.
Drug Elimination:
Fecal (80%), renal. Mean terminal half-life: 116 hours.
How Supplied:
Single-dose vial (1mL, 4mL)—1
Prostate and other male cancers:
Indications for: TAXOTERE
In combination with prednisone: metastatic castration-resistant prostate cancer.
Adult Dosage:
Give by IV infusion over 1hr once every 3 weeks. 75mg/m2. Premedicate with oral corticosteroid. Adjust dose based on tolerability and effect (see full labeling); allow neutrophils and platelets to recover before subsequent cycles.
Children Dosage:
Not established.
TAXOTERE Contraindications:
Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.
Boxed Warning:
Toxic deaths. Hepatotoxicity. Neutropenia. Hypersensitivity reactions. Fluid retention.
TAXOTERE Warnings/Precautions:
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
TAXOTERE Classification:
Antimicrotubule agent.
TAXOTERE Interactions:
Avoid or minimize alcohol intake. May be affected by CYP3A4 inhibitors, inducers, or substrates. Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole); if co-administration necessary, consider dose reduction by 50%.
Adverse Reactions:
Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, myalgia; hepatotoxicity, death (septic and nonseptic), cystoid macular edema, severe cutaneous reactions (eg, SJS, TEN, AGEP), alcohol intoxication, enterocolitis and neutropenic colitis.
Drug Elimination:
Fecal (80%), renal. Mean terminal half-life: 116 hours.
How Supplied:
Single-dose vial (1mL, 4mL)—1
Respiratory and thoracic cancers:
Indications for: TAXOTERE
Locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. In combination with cisplatin: initial treatment of unresectable, locally advanced or metastatic non-small cell lung cancer without previous chemotherapy.
Adult Dosage:
Give by IV infusion over 1hr once every 3 weeks. NSCLC after platinum therapy failure: 75mg/m2. Chemotherapy-naive NSCLC: 75mg/m2 followed by cisplatin (see full labeling). Premedicate with oral corticosteroid. Adjust dose based on tolerability and effect (see full labeling); allow neutrophils and platelets to recover before subsequent cycles.
Children Dosage:
Not established.
TAXOTERE Contraindications:
Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.
Boxed Warning:
Toxic deaths. Hepatotoxicity. Neutropenia. Hypersensitivity reactions. Fluid retention.
TAXOTERE Warnings/Precautions:
Increased risk of mortality in those with abnormal liver function, receiving high doses, with NSCLC and a history of prior platinum-based chemotherapy. Hepatic impairment; bilirubin >ULN, AST and/or ALT >1.5×ULN concomitant with alkaline phosphatase >2.5×ULN: avoid. Obtain bilirubin, AST/ALT, and alkaline phosphatase prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Patients with neutropenia: monitor closely for GI toxicity. Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Previous history of hypersensitivity to paclitaxel; monitor closely. Pre-existing effusions (monitor closely). Monitor for second primary malignancies (eg, AML, MDS, NHL, renal cancer). Monitor closely for severe cutaneous adverse reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP]); consider permanent discontinuation if occur. Adjust dose if severe neurosensory symptoms (eg, paresthesia, dysesthesia, pain) occur; discontinue if symptoms persist. Monitor for eye disorders; discontinue if cystoid macular edema is diagnosed (consider alternative non-taxane chemotherapy). Risk of tumor lysis syndrome (esp. in renal impairment, hyperuricemia, bulky tumor): monitor closely. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
TAXOTERE Classification:
Antimicrotubule agent.
TAXOTERE Interactions:
Avoid or minimize alcohol intake. May be affected by CYP3A4 inhibitors, inducers, or substrates. Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole); if co-administration necessary, consider dose reduction by 50%.
Adverse Reactions:
Infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, myalgia; hepatotoxicity, death (septic and nonseptic), cystoid macular edema, severe cutaneous reactions (eg, SJS, TEN, AGEP), alcohol intoxication, enterocolitis and neutropenic colitis.
Drug Elimination:
Fecal (80%), renal. Mean terminal half-life: 116 hours.
How Supplied:
Single-dose vial (1mL, 4mL)—1
