Docetaxel Advagen

Docetaxel Advagen

docetaxel

Manufacturer:

Advagen

Distributor:

Advagen
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
Locally advanced or metastatic breast carcinoma; in combination w/ doxorubicin & cyclophosphamide for the adjuvant treatment of patients w/ operable node-positive & negative breast cancer. Locally advanced or metastatic non-small cell lung cancer. Metastatic carcinoma of the ovary after failure of 1st-line or subsequent chemotherapy. In combination w/ prednisone or prednisolone for patients w/ hormone refractory metastatic prostate cancer. In combination w/ cisplatin & 5-fluorouracil for the patients w/ metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction who have not received prior chemotherapy for metastatic disease; induction treatment of patients w/ locally advanced squamous cell carcinoma of the head & neck.
Dosage/Direction for Use
Breast, non-small cell lung, ovarian, gastric, head & neck cancer Oral corticosteroid eg, dexamethasone 16 mg/day for 3 days starting 1 day prior to docetaxel administration. Prostate cancer premed Oral dexamethasone 8 mg 12 hr, 3 hr & 1 hr before infusion. Adjuvant treatment of operable node-positive & negative breast cancer 75 mg/m2 1 hr after doxorubicin 50 mg/m2 & cyclophosphamide 500 mg/m2 every 3 wk for 6 cycles. Locally advanced or metastatic breast cancer 100 mg/m2 in monotherapy. In 1st-line treatment, 60 mg/m2 is given in combination therapy w/ doxorubicin 50 mg/m2. In combination w/ trastuzumab 100 mg/m2 every 3 wk w/ trastuzumab administered wkly; w/ capecitabine 75 mg/m2 every 3 wk, combined w/ capecitabine at 1,250 mg/m2 bd for 2 wk followed by 1-wk rest period. Non-small cell lung cancer 75 mg/m2 followed by cisplatin 75 mg/m2 over 30-60 min. Treatment after failure of prior platinum-based chemotherapy 75 mg/m2 as a single agent. Prostate cancer 75 mg/m2 w/ continuous oral prednisone or prednisolone 5 mg bd. Ovarian cancer 100 mg/m2 as 1-hr infusion every 3 wk. Gastric adenocarcinoma 75 mg/m2 as 1-hr infusion, followed by cisplatin 75 mg/m2 as 1-3 hr infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2/day as 24-hr continuous infusion for 5 days starting at the end of the cisplatin infusion; repeat treatment every 3 wk. Head & neck cancer Induction chemotherapy followed by radiotherapy (TAX 323): 75 mg/m2 as 1-hr infusion followed by cisplatin 75 mg/m2 over 1 hr on day 1 followed by 5-fluorouracil 750 mg/m2/day as continuous infusion for 5 days. Regimen is administered every 3 wk for 4 cycles. Induction chemotherapy followed by chemoradiotherapy (TAX 324): 75 mg/m2 as 1-hr IV infusion on day 1, followed by cisplatin 100 mg/m2 as a 30-min to 3-hr infusion followed by 5-fluorouracil 1,000 mg/m2/day as continuous infusion from day 1-4. Regimen is administered every 3 wk for 3 cycles. Elderly ≥60 yr, in combination w/ capecitabine Reduce capecitabine starting dose to 75%.
Contraindications
Hypersensitivity. Baseline neutrophil count of <1,500 cells/mm3. Severe liver impairment. Other medicinal products when combined w/ docetaxel.
Special Precautions
Reduce subsequent doses in case of severe neutropenia (<500 cells/mm3 for ≥7 days); severe peripheral neurotoxicity. Closely observe patients for hypersensitivity reactions especially during the 1st & 2nd infusions. Localized skin erythema of the extremities w/ oedema followed by desquamation may occur. Closely monitor patients w/ severe fluid retention eg, pleural & pericardial effusion & ascites. Acute resp distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis & resp failure. Monitor cardiac function during treatment. Discontinue use & initiate appropriate treatment if cystoid macular oedema is diagnosed. Complicated neutropenia; GI reactions; monitor for CHF symptoms during therapy & follow-up period; leukemia; patients w/ 4+ nodes. Avoid concomitant use w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin & voriconazole). Contains ethanol anhydrous which may be harmful for those suffering from alcoholism. May impair ability to drive or use machines. Patients w/ epilepsy. Liver & renal impairment. Contraceptive measures must be taken by both men & women during treatment & at least 6 mth after therapy cessation. Men should not father a child during & up to 6 mth after treatment. Women of childbearing potential should be advised to avoid becoming pregnant. Not to be used during pregnancy. Discontinue during lactation. Childn <18 yr. Closely monitor elderly treated w/ TCF.
Adverse Reactions
Neutropenia, anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea & asthenia.
Drug Interactions
Metabolism may be modified by compd which induce, inhibit or metabolized by CYP450-3A (eg, ciclosporine, ketoconazole & erythromycin). May increase AR w/ strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir telithromycin & voriconazole). Increased clearance of carboplatin.
ATC Classification
L01CD02 - docetaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Presentation/Packing
Form
Docetaxel Advagen conc for soln for infusion 80 mg/4 mL
Packing/Price
1's
Form
Docetaxel Advagen conc for soln for infusion 20 mg/mL
Packing/Price
1's
Form
Docetaxel Advagen conc for soln for infusion 160 mg/8 mL
Packing/Price
1's
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