Napro-Tax

Paclitaxel

Malignant breast & ovary neoplasms, & in advanced NSCLC; other malignancies including head & neck tumours, prostate & Kaposi's sarcoma (KS).

1st-line treatment of ovarian cancer Paclitaxel 175 mg/m² IV infusion over 3 hr followed thereafter by cisplatin 75 mg/m² repeated at 3-wk intervals, or paclitaxel 135 mg/m² IV infusion over 24 hr followed thereafter by cisplatin 75 mg/m² repeated at 3-wk intervals. 2nd-line treatment of ovarian cancer 175 mg/m² over 3 hr w/ 3-wk interval between courses. 1st-line chemotherapy of breast carcinoma In combination w/ doxorubicin 50 mg/m², administer paclitaxel 24-hr after doxorubicin. Recommended dose: Paclitaxel 220 mg/m² IV over 3 hr w/ 3-wk interval between courses. When used in combination w/ trastuzumab, paclitaxel infusion may be started the day following trastuzumab 1st dose or immediately after trastuzumab subsequent doses if well tolerated. Recommended dose: Paclitaxel 175 mg/m² over 3 hr w/ 3-wk interval between courses. 2nd-line chemotherapy of breast carcinoma 175 mg/m² over 3 hr w/ 3-wk interval between courses. Adjuvant chemotherapy in breast carcinoma 175 mg/m² over 3 hr every 3 wk for 4 courses following AC therapy. 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 a 3-hr IV infusion every 2 wk. Premed: Oral dexamethasone 20 mg approx 12 & 6 hr or IV dexamethasone 30-60 min prior to paclitaxel. Diphenhydramine 50 mg IV 30-60 min prior to paclitaxel. Cimetidine (300 mg) or ranitidine (50 mg) IV 30-60 min prior to paclitaxel.

Hypersensitivity to paclitaxel or other drugs formulated in cremophor EL (polyethoxylated castor oil). Severe baseline neutropenia (<1,500 cells/mm³).

Immediately discontinue infusion in case of severe hypersensitivity reactions & initiate symptomatic therapy. Closely monitor infusion site for possible infiltration during administration. Pretreat patients w/ corticosteroids, antihistamines & H₂ antagonists. Institute frequent blood count monitoring; not to be retreated until neutrophil count is ≥1.5 x 10⁹/L (≥1 x 10⁹/L for KS patients) & platelets recover to ≥100 x 10⁹/L (≥75 x 10⁹/L for KS patients). Rarely, severe cardiac conduction abnormalities; perform continuous cardiac monitoring during subsequent therapy. Frequently monitor vital signs particularly during the 1st hr of infusion. Patients should undergo baseline cardiac assessment including history, physical exam, ECG, echocardiogram &/or multigated acquisition scan when used in combination w/ doxorubicin or trastuzumab for initial treatment of metastatic breast cancer; further monitor cardiac function during treatment (eg, every 3 mth). Possible peripheral neuropathy. Contains ethanol; may be harmful to patients suffering from alcoholism. Avoid intra-arterial administration. Possible pseudomembranous colitis. May promote development of interstitial pneumonitis in combination w/ pulmonary RT. Possible severe mucositis in KS patients. Patients w/ hepatic impairment may be at increased risk of toxicity particularly grade 3-4 myelosuppression. Mild to moderate hepatic impairment; patients w/ severe hepatic impairment must not be treated w/ paclitaxel. Teratogen; female & male patients of reproductive age must take contraceptive measures &/or their partners during & for at least 6 mth after therapy. Possible irreversible infertility; advise male patients on sperm conservation prior to treatment. Pregnancy. Not to be administered to nursing mothers. Not recommended for use in childn <18 yr.

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

Decreased clearance when administered following cisplatin. Possible sequence effects characterised by more profound neutropenic & stomatitis episodes when administered before doxorubicin & when using longer than recommended infusion times.

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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