Clipax

Paclitaxel

Ovarian cancer: 1st-line chemotherapy in patients w/ advanced or residual disease (>1 cm) after initial laparotomy in combination w/ cisplatin; 2nd-line chemotherapy in ovarian metastatic carcinoma after failure of standard platinum-based therapy. Breast cancer: Adjuvant in node +ve breast carcinoma following anthracycline & cyclophosphamide (AC) therapy; initial treatment of locally advanced or metastatic breast cancer in combination w/ anthracycline or trastuzumab in patients who over-express human epidermal growth factor receptor 2 (HER-2) at 3+ level; as single agent in metastatic breast carcinoma in patients who have failed to respond adequately to standard anthracycline treatment or in whom anthracycline therapy has not been appropriate. Advanced NSCLC in combination w/ cisplatin in patients not candidates for potentially curative surgical intervention &/or RT. Advanced AIDS-related Kaposi's sarcoma (KS) in patients who have failed prior lipos anthracycline therapy.

Premedication prior to paclitaxel administration Dexamethasone 20 mg orally (8-20 mg for KS patient) approx 12 & 6 hr or IV 30-60 min. Diphenhydramine 50 mg or an equiv antihistamine (eg, chlorphenamine 10 mg) IV 30-60 min. Cimetidine 300 mg or ranitidine 50 mg IV 30-60 min. Ovarian cancer: 1st-line treatment 175 mg/m² IV infusion over 3 hr followed by cisplatin 75 mg/m². then repeated at 3-wk interval; or 135 mg/m² IV infusion over 24 hr followed by cisplatin 75 mg/m², then repeated at 3-wk interval. 2nd-line treatment 175 mg/m² over 3 hr w/ 3-wk interval between courses. Breast carcinoma: Adjuvant chemotherapy 175 mg/m² over 3 hr every 3 wk for 4 courses following AC therapy. 1st-line chemotherapy In combination w/ doxorubicin: 220 mg/m² IV over 3 hr w/ 3-wk interval between courses administered 24 hr after doxorubicin 50 mg/m². In combination w/ trastuzumab: 175 mg/m² IV over 3 hr w/ 3-wk interval between courses administered the day following 1st dose or immediately after subsequent doses of trastuzumab. 2nd-line chemotherapy 175 mg/m² over 3 hr w/ 3-wk interval between courses. Advanced NSCLC 175 mg/m² over 3 hr followed by cisplatin 80 mg/m² w/ 3-wk interval between courses. AIDS-related KS 100 mg/m² as 3-hr IV infusion every 2 wk. Dose adjustment Patient who experience severe neutropenia (neutrophil count <0.5 x 10⁹/L for min: 7 days) or severe peripheral neuropathy Dose reduction of 20% for subsequent courses (25% for KS patient). KS patient w/ severe mucositis Reduce dose by 25%.

Hypersensitivity to paclitaxel or macrogolglycerol ricinoleate (polyoxyl castor oil). Not to be used in patients w/ baseline neutrophils <1.5 x 10⁹/L (<1 x 10⁹/L for KS patients) or platelets <100 x 10⁹/L (<75 x 10⁹/L for KS patients). KS patients w/ concurrent, serious, uncontrolled infections. Not to be used to treat patients w/ severe hepatic impairment. Lactation.

Discontinue use in case of severe hypersensitivity reactions. Avoid intra-arterial administration. Pretreat patients w/ corticosteroids, antihistamines & H₂ antagonists. Peripheral neuropathy. Pseudomembranous colitis. Interstitial pneumonitis may develop in combination w/ pulmonary RT. Closely monitor infusion site given the possibility of extravasation during administration. Frequently monitor blood counts, cardiac function (if severe conduction abnormalities develop), vital signs (particularly during 1st hr of infusion) & for development of profound myelosuppression. Perform baseline cardiac assessment including history, physical exam, ECG, echocardiogram &/or multigated acquisition scan in combination w/ doxorubicin or trastuzumab & monitor cardiac function during treatment eg, every 3 mth. Closely monitor for development of profound myelosuppression. Contains ethanol. Should be given before cisplatin when used in combination. Mild-moderate hepatic impairment. Not to be used pregnancy. Female & male patients of reproductive age must take contraception during & for at least 6 mth after therapy. Not recommended in childn <18 yr.

Infection (UTI & URTI); myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopenia, bleeding; minor hypersensitivity reactions (flushing & rash); neurotoxicity (peripheral neuropathy); hypotension; nausea, vomiting, diarrhoea, mucosal inflammation; alopecia; arthralgia, myalgia. Bradycardia; transient & mild nail & skin changes; inj site reactions (including localised oedema, pain, erythema, induration, cellulitis, skin fibrosis & necrosis); severe elevation in AST (SGOT) & alkaline phosphatase.

Greater myelosuppression & decreased clearance when given after cisplatin. Reduced elimination of doxorubicin. Caution in concomitant administration w/ CYP2C8 or 3A4 inhibitors (eg, erythromycin, fluoxetine, gemfibrozil) or inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb, efivarenz, nevirapine); PIs. Lowered systemic clearance w/ nelfinavir & ritonavir in KS patients.

Cytotoxic Chemotherapy

L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.

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