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TAXOTERE
Breast cancer
Colorectal and other GI cancers
Head and neck cancer
Prostate and other male cancers
Respiratory and thoracic cancers
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Drug Name:

TAXOTERE Rx

Generic Name and Formulations:
Docetaxel 20mg/mL; soln for IV infusion after dilution; contains polysorbate 80; diluent contains alcohol.

Company:
Sanofi Aventis

Therapeutic Use:

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:

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:

Not established.

Contraindications:

Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.

Warnings/Precautions:

Hepatic dysfunction; bilirubin >ULN, AST and/or ALT >1.5XULN concomitant with alkaline phosphatase >2.5XULN: not recommended. Obtain bilirubin, AST/ALT, and alkaline phosphatase values prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Pre-existing effusions. 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). Elderly. Pregnancy (Cat.D; use adequate contraception). Nursing mothers: not recommended.

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%.

Pharmacological Class:

Antimicrotubule agent.

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; cutaneous reactions (eg, erythema, edema, desquamation), hepatotoxicity, acute myeloid leukemia, death (septic and nonseptic), cystoid macular edema, alcohol intoxication.

How Supplied:

Single-dose vials (1mL, 4mL, 8mL)—1 (w. diluent, supplies)

Indications for TAXOTERE:

In combination with cisplatin and fluorouracil: advanced gastric adenocarcinoma without previous chemotherapy.

Adult:

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:

Not established.

Contraindications:

Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.

Warnings/Precautions:

Hepatic dysfunction; bilirubin >ULN, AST and/or ALT >1.5XULN concomitant with alkaline phosphatase >2.5XULN: not recommended. Obtain bilirubin, AST/ALT, and alkaline phosphatase values prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Pre-existing effusions. 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). Elderly. Pregnancy (Cat.D; use adequate contraception). Nursing mothers: not recommended.

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%.

Pharmacological Class:

Antimicrotubule agent.

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; cutaneous reactions (eg, erythema, edema, desquamation), hepatotoxicity, acute myeloid leukemia, death (septic and nonseptic), cystoid macular edema, alcohol intoxication.

How Supplied:

Single-dose vials (1mL, 4mL, 8mL)—1 (w. diluent, supplies)

Indications for TAXOTERE:

In combination with cisplatin and fluorouracil: induction treatment of locally advanced squamous cell carcinoma of the head and neck.

Adult:

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:

Not established.

Contraindications:

Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.

Warnings/Precautions:

Hepatic dysfunction; bilirubin >ULN, AST and/or ALT >1.5XULN concomitant with alkaline phosphatase >2.5XULN: not recommended. Obtain bilirubin, AST/ALT, and alkaline phosphatase values prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Pre-existing effusions. 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). Elderly. Pregnancy (Cat.D; use adequate contraception). Nursing mothers: not recommended.

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%.

Pharmacological Class:

Antimicrotubule agent.

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; cutaneous reactions (eg, erythema, edema, desquamation), hepatotoxicity, acute myeloid leukemia, death (septic and nonseptic), cystoid macular edema, alcohol intoxication.

How Supplied:

Single-dose vials (1mL, 4mL, 8mL)—1 (w. diluent, supplies)

Indications for TAXOTERE:

In combination with prednisone: hormone-refractory metastatic prostate cancer.

Adult:

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:

Not established.

Contraindications:

Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.

Warnings/Precautions:

Hepatic dysfunction; bilirubin >ULN, AST and/or ALT >1.5XULN concomitant with alkaline phosphatase >2.5XULN: not recommended. Obtain bilirubin, AST/ALT, and alkaline phosphatase values prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Pre-existing effusions. 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). Elderly. Pregnancy (Cat.D; use adequate contraception). Nursing mothers: not recommended.

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%.

Pharmacological Class:

Antimicrotubule agent.

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; cutaneous reactions (eg, erythema, edema, desquamation), hepatotoxicity, acute myeloid leukemia, death (septic and nonseptic), cystoid macular edema, alcohol intoxication.

How Supplied:

Single-dose vials (1mL, 4mL, 8mL)—1 (w. diluent, supplies)

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:

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:

Not established.

Contraindications:

Neutrophil count <1500 cells/mm3. Hypersensitivity to polysorbate 80.

Warnings/Precautions:

Hepatic dysfunction; bilirubin >ULN, AST and/or ALT >1.5XULN concomitant with alkaline phosphatase >2.5XULN: not recommended. Obtain bilirubin, AST/ALT, and alkaline phosphatase values prior to each cycle. Monitor peripheral blood counts frequently (esp. neutrophils, platelets). Monitor for hypersensitivity reactions (esp. during 1st and 2nd infusions); discontinue if severe and do not rechallenge. Pre-existing effusions. 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). Elderly. Pregnancy (Cat.D; use adequate contraception). Nursing mothers: not recommended.

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%.

Pharmacological Class:

Antimicrotubule agent.

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; cutaneous reactions (eg, erythema, edema, desquamation), hepatotoxicity, acute myeloid leukemia, death (septic and nonseptic), cystoid macular edema, alcohol intoxication.

How Supplied:

Single-dose vials (1mL, 4mL, 8mL)—1 (w. diluent, supplies)

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