Anzatax

Paclitaxel

Primary treatment of ovarian cancer in combination w/ platinum agent. Metastatic ovarian or breast cancer after failure of standard therapy; NSCLC. Metastatic breast cancer in combination w/ trastuzumab in patients who have tumours that overexpress HER2 at 3+ level & who has not received previous chemotherapy.

Primary treatment of ovarian cancer 175 mg/m² IV over 3 hr or 135 mg/m² IV over 24 hr, followed by cisplatin 75 mg/m² repeated every 3 wk. Metastatic ovarian or breast cancer; primary or secondary treatment of NSCLC 175 mg/m² IV over 3 hr repeated every 3 wk.

Hypersensitivity to paclitaxel, other taxanes, PEG-35 castor oil or drugs formulated in PEG-35 castor oil. Patients w/ solid tumours who have baseline neutrophil counts of <1.5 x 10⁹ cells/L.

Discontinue use if severe hypersensitivity reactions, cystoid macular oedema occur. Not to be administered as intracerebral, intrapleural or intraperitoneal inj; in patients w/ pre-treatment neutrophil count <1.5 x 10⁹ cells/L (1,500 cells/mm³) or platelet count <100 x 10⁹ cells/L. Premed w/ corticosteroids (eg, dexamethasone), antihistamines (eg, diphenhydramine or promethazine) & H₂-receptor antagonist (eg, cimetidine or ranitidine) before every treatment cycle. Exclude bowel perforation in patients w/ abdominal pain. Preexisting neuropathy; CNS, other effects of alcohol; interstitial pneumonia; pseudomembranous colitis; severe mucositis. Perform baseline cardiac assessment including history, physical exam, ECG, echocardiogram &/or MUGA scan; prompt & complete ophth exam in patients w/ visual impairment. Monitor cardiac function during treatment eg, every 3 mth. Ensure correct position of indwelling catheter to avoid extravasation, necrosis &/or thrombophlebitis. May affect ability to drive & use machines. Hepatic & renal impairment. May impair fertility. Women of childbearing potential should use effective contraception during & at least 6 mth after last dose. Male patients should not father a child during & at least 3 mth after last dose. Not to be used during pregnancy & lactation. Elderly. Not recommended in childn <18 yr.

Hypotension; myelosuppression, thrombocytopenia, leucopoenia, fever, bleeding, anaemia, neutropenia; elevated alkaline phosphatase, AST & ALT; flushing, rash; infection; nausea, vomiting, diarrhoea, mucositis; arthralgia, myalgia; peripheral neuropathy; alopecia. Bradycardia; ECG abnormalities; febrile neutropenia; elevated bilirubin; dyspnoea, chest pain, tachycardia; inj site reactions.

Decreased clearance w/ cisplatin. Increased doxorubicin plasma levels. Elevated mean serum trough conc of trastuzumab. Higher incidence of arthralgia or myalgia w/ filgrastim. Potent CYP3A4 inhibitors eg, ketoconazole; CYP2C8 or 3A4 inhibitors (eg, erythromycin, fluoxetine, gemfibrozil, deferasirox, trimethoprim) or inducers (eg, rifampicin, carbamazepine, phenytoin, phenobarb, efavirenz, nevirapine, St John’s wort).

Cytotoxic Chemotherapy

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

B