Docetaxel Sandoz

Docetaxel Sandoz

docetaxel

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Docetaxel
Indications/Uses
Adjuvant treatment of operable node-positive breast cancer in combination w/ doxorubicin & cyclophosphamide. Locally advanced or metastatic breast cancer: As monotherapy after failure of cytotoxic therapy w/ anthracycline or alkylating agent; in combination w/ doxorubicin who have not previously received cytotoxic therapy; in combination w/ capecitabine after failure of cytotoxic therapy w/ anthracycline. Metastatic breast cancer whose tumors overexpress HER2 & who have not received previous chemotherapy for metastatic disease in combination w/ trastuzumab. Locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Unresectable, locally advanced or metastatic non-small cell lung cancer in patients who have not previously received chemotherapy for this condition in combination w/ cisplatin. Hormone refractory metastatic prostate cancer in combination w/ prednisone or prednisolone. Metastatic gastric adenocarcinoma, including adenocarcinoma of gastroesophageal junction w/o prior chemotherapy for metastatic disease in combination w/ cisplatin & 5-fluorouracil. Induction treatment of locally advanced squamous cell carcinoma of the head & neck in combination w/ cisplatin & 5-fluorouracil.
Dosage/Direction for Use
Premedication Breast, non-small cell lung, gastric, & head & neck cancers Oral corticosteroid eg, dexamethasone 16 mg daily for 3 days starting 1 day prior to docetaxel administration. Prostate cancer Oral dexamethasone 8 mg, 12 hr, 3 hr & 1 hr prior to docetaxel infusion in concurrent use w/ prednisone or prednisolone. Adjuvant treatment of operable node-positive 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 Monotherapy: 100 mg/m2. 1st-line treatment: In combination w/ doxorubicin: 75 mg/m2 w/ doxorubicin 50 mg/m2; In combination w/ trastuzumab: 100 mg/m2 every 3 wk w/ trastuzumab wkly; In combination w/ capecitabine: 75 mg/m2 every 3 wk w/ capecitabine 1,250 mg/m2 bd for 2 wk followed by 1-wk rest period. Non-small cell lung cancer Chemotherapy naïve patients 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 min. After failure of prior platinum-based chemotherapy 75 mg/m2 as single agent. Prostate cancer 75 mg/m2 w/ oral prednisone or prednisolone 5 mg bd administered continuously. 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 daily as 24-hr continuous infusion starting at end of cisplatin infusion for 5 days. Repeat every 3 wk. Induction treatment of inoperable locally advanced squamous cell carcinoma of the head & neck (SCCHN) 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 daily as continuous infusion for 5 days. Repeat every 3 wk for 4 cycles. Induction treatment of locally advanced (technically unresectable, low probability of surgical cure, & aiming at organ preservation) SCCHN followed by chemotherapy (TAX 324) 75 mg/m2 as 1-hr IV infusion on day 1 followed by cisplatin 100 mg/m2 as 30 min-3 hr infusion, followed by 5-fluorouracil 1,000 mg/m2 daily as continuous infusion from day 1-4. Repeat every 3 wk for 3 cycles.
Contraindications
Hypersensitivity. Baseline neutrophil count <1,500 cells/mm3. Severe liver impairment. Pregnancy & lactation.
Special Precautions
Neutropenia. Discontinue therapy in case of severe hypersensitivity reactions eg, severe hypotension, bronchospasm or generalised rash/erythema, or severe symptoms eg, eruptions followed by desquamation. Monitor complete blood counts frequently, patients receiving TCF, w/ severe fluid retention, cardiac function in combination w/ trastuzumab during treatment. Reduce dose in case of severe neutropenia <500 cells/mm3 for ≥7 days & development of severe peripheral neurotoxicity. During adjuvant therapy of breast cancer, monitor for complicated neutropenia, manifestations of serious GI toxicity, symptoms of CHF during & follow up period, patient receiving TAC. Contains alcohol, caution in alcoholism, childn & high-risk patients eg, liver disease, CNS disease eg, epilepsy. May impair ability to drive or use machines. Hepatic & severe renal impairment. Contraceptive measures should be taken by men & women during & at least 3 mth after therapy. Childn. Elderly.
Adverse Reactions
Neutropenia, anaemia, thrombocytopenia; peripheral sensory neuropathy; stomatitis, diarrhoea, nausea, vomiting; alopecia, skin reaction; anorexia; infections; fluid retention, asthenia, pain. Increased blood bilirubin; arrhythmia; febrile neutropenia; peripheral motor neuropathy; constipation; nail disorders; myalgia; hypotension. Hypersensitivity. Increased blood alkaline phosphatase, AST & ALT; abdominal pain, GI haemorrhage; arthralgia; infection associated w/ G4 neutropenia; HTN, haemorrhage; infusion site reaction, non-cardiac chest pain.
Drug Interactions
Metabolism may be modified by compd which induce, inhibit or metabolized by cytochrome P450-3A eg, ciclosporine, terfenadine, ketoconazole, erythromycin & troleandomycin. Increased carboplatin clearance.
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 Sandoz infusion conc 20 mg/2 mL
Packing/Price
1's
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