Docexan-20mg-0-5ml

Docetaxel is indicated for Breast, Non-Small Cell Lung, Gastric and Head and Neck Cancers, Prostate Cancer, Breast Cancer, Patients with Locally Advanced or Metastatic Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Prostate Cancer, Gastric Adenocarcinoma, Head and Neck Cancer, Induction Treatment of Inoperable, Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Cance,

Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin. The binding of docetaxel to microtubules does not alter the number of protofilaments.Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.

Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays. Docetaxel achieves high intracellular concentrations with a long cell residence time. In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene. In vivo, docetaxel is schedule-independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.

Breast, non-small cell lung, gastric, head & neck cancers: Premedication consisting of an oral corticosteroid eg dexamethasone 16 mg/day (8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration.Prostate cancer: Given the concurrent use of prednisone or prednisolone, the recommended premedication regimen: Oral dexamethasone 8 mg 12 hr, 3 hr & 1 hr before docetaxel infusion. Administered as 1-hr infusion every 3 wk.

Breast cancer:

• In the adjuvant treatment of operable node +ve: 75 mg/m² administered 1 hr after doxorubicin 50 mg/m² & cyclophosphamide 500 mg/m² every 3 wk for 6 cycles.
• For the treatment of patients with locally advanced or metastatic breast cancer: 100 mg/m² in monotherapy.
• In the 1st-line treatment combination therapy: 75 mg/m² with doxorubicin (50 mg/m²).
• In combination with trastuzumab: 100 mg/m² every 3 wk, administered wkly.
• In combination with capecitabine: 75 mg/m² every 3 wk, combined with capecitabine at 1250 mg/m² twice daily (within 30 min after a meal) for 2 wk followed by a 1-wk rest period.

Non-small cell lung cancer:

• In chemotherapy-naive patients treated for non-small cell lung cancer: 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 min.
• For treatment after failure of prior platinum-based chemotherapy: 75 mg/m² as a single agent.

Prostate cancer: 75 mg/m². Prednisone or prednisolone 5 mg orally twice daily is 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/day given as 24-hr continuous infusion for 5 days, starting at the end of the cisplatin infusion.

Head & neck cancer: For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head & neck: 75 mg/m² as 1-hr infusion followed by cisplatin 75 mg/m² over 1 hr on day 1, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for 5 days. Administered every 3 wk for 4 cycles. Following chemotherapy, patients should receive radiotherapy.

Ovarian cancer: 75-100 mg/m² administered as 1-hr infusion every 3 wk.

CYP P450-3A inhibitor eg, ciclosporine, terfenadine, ketoconazole, erythromycin & troleandomycin. Increased clearance of carboplatin. Potent CYP3A4 inhibitors eg, protease inhibitors eg, ritonavir, azole antifungals eg, ketoconazole or itraconazole.

Severe hypersensitivity to docetaxel. Neutrophil count of <1500 cell/mm3. Severe liver impairment. Pregnancy & lactation.

Neutropenia, anaemia, alopecia, nausea, asthenia, hypersensitivity, anorexia, neurologic effects, neuropathy, dizziness, dyspnoea, epitaxis, GI effects, skin & cutaneous reactions, myalgia, fluid retention, pain, lacrimation increased, conjunctivitis, lymphoedema, pharyngolaryngeal pain, oedema peripheral, fatigue, vasodilation, amenorrhoea, pyrexia, lethargy, fever, arrhythmia, hypotension, dehydration.

Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).