Docetax

Docetax

docetaxel

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
Adjuvant treatment in operable node +ve/-ve breast cancer in combination w/ doxorubicin & cyclophosphamide. Locally advanced or metastatic breast cancer who have not previously received cytotoxic chemotherapy in combination w/ doxorubicin; in combination w/ capecitabine after failure of prior anthracycline-containing chemotherapy; as monotherapy after failure w/ cytotoxic chemotherapy. Metastatic breast cancer whose tumors over express HER2 & w/o prior chemotherapy for metastatic disease in combination w/ trastuzumab. Locally advanced or metastatic non-small cell lung cancer (NSCLC) as monotherapy after failure of prior chemotherapy. Unresectable locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition in combination w/ cisplatin. Metastatic ovarian carcinoma after failure of 1st-line or subsequent chemotherapy. Androgen independent (hormone-refractory) metastatic prostate cancer in combination w/ prednisone or prednisolone. Metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction who have not received prior chemotherapy for metastatic disease in combination w/ cisplatin & 5-FU. Locally advanced squamous cell carcinoma of the head & neck (SCCHN) in combination w/ cisplatin & 5-FU. Recurrent &/or metastatic SCCHN after failure of previous chemotherapy.
Dosage/Direction for Use
Locally advanced or metastatic breast cancer after failure of prior chemotherapy 100 mg/m2 docetaxel as a 1-hr IV infusion every 3 wk. In combination w/ doxorubicin 50 mg/m2: 75 mg/m2 docetaxel as 1-hr IV infusion every 3 wk. Adjuvant treatment of operable node +ve & -ve breast cancer 75 mg/m2 docetaxel as 1 hr IV infusion after doxorubicin 50 mg/m2 & cyclophosphamide 500 mg/m2 every 3 wk for 6 cycles. In combination w/ trastuzumab: 100 mg/m2 docetaxel every 3 wk w/ trastuzumab administered wkly. In combination w/ capecitabine: 75 mg/m2 docetaxel as 1 hr IV infusion every 3 wk combined w/ capecitabine 1250 mg/m2 bid for 2 wk followed by 1-wk rest period. NSCLC after failure of prior platinum-based chemotherapy 75 mg/m2 docetaxel as 1 hr IV infusion. Patient w/ NSCLC who have not previously received chemotherapy 75 mg/m2 docetaxel as 1 hr IV infusion immediately followed by cisplatin 75 mg/m2 over 30-60 min every 3 wk. Prostate cancer 75 mg/m2 docetaxel as 1 hr IV infusion every 3 wk. Administer oral prednisone/prednisolone 5 mg bid continuously from Day 1 & through each cycle. Gastric cancer 75 mg/m2 docetaxel as 1-hr IV infusion followed by cisplatin 75 mg/m2 as 1-3 hr IV infusion (both on Day 1). Starting at the end of cisplatin infusion give 5-FU 750 mg/m2/day as a 24 hr continuous infusion for 5 days. Repeat treatment every 3 wk. Induction treatment of locally advanced inoperable SCCHN 75 mg/m2 docetaxel as 1-hr IV infusion followed by cisplatin 75 mg/m2 IV over 1 hr (Day 1) followed by 5-FU 750 mg/m2/day as continuous IV infusion for 5 days every 3 wk for 4 cycles. Induction treatment of patient w/ locally advanced (unresectable low surgical cure, or organ preservation) SCCHN 75 mg/m2 docetaxel as 1 hr IV infusion (Day 1) followed by cisplatin 100 mg/m2 as a 30 min to 3 hr IV infusion, followed by 5-FU 1,000 mg/m2/day as continuous IV infusion for 4 days every 3 wk for 3 cycles. Hepatic impairment (>1.5 x ULN, ALT &/or AST levels, >2.5 x ULN AP) level in patient treated w/ 100 mg/m2 75 mg/m2 docetaxel.
Contraindications
Hypersensitivity. Neutrophil counts <1,500 cells/mm3. Severe liver impairment. Pregnancy & lactation.
Special Precautions
Neutropenia, severe fluid retention. Acute myeloid leukemia. Perform peripheral blood cell counts. Monitor patients receiving TCF & TAC. Severe neurosensory symptoms eg, paresthesia, dysesthesia, pain. Localized skin erythema of the extremities, severe asthenia. Hepatic impairment. Acute resp distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis & resp failure. Heart failure. Monitor for signs of CHF during therapy & follow-up period. Cystoids macular edema. Patients w/ impaired vision should undergo a prompt & complete ophthalmologic examination. Avoid or minimize alcohol intake. Women & men of reproductive potential should use an effective method of contraception. May affect ability to drive & operate machines. Renal impairment. Childn. Elderly.
Adverse Reactions
Infection, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, myalgia.
Drug Interactions
Docetaxel metabolism may be modified w/ concomitant use w/ drugs that induce, inhibit or are metabolized by CYP3A4 eg, cyclosporine, terfenadine, ketoconazole, erythromycin & troleandomycin. Avoid concomitant use w/ CYP3A4 inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. Increased AUC w/ ketoconazole. Increased carboplatin clearance.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Docetax infusion conc 20 mg/0.5 mL
Packing/Price
(+ 1.5 mL vial diluent) 1's
Form
Docetax infusion conc 80 mg/2 mL
Packing/Price
(+ 6 mL vial diluent) 1's
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