Anzatax

Paclitaxel

Primary treatment of ovarian cancer in combination w/ a platinum agent. Metastatic ovarian & breast cancer after failure of standard therapy. NSCLC. Adjuvant treatment of node +ve breast cancer administered sequentially to doxorubicin & cyclophosphamide. In combination w/ trastuzumab (Herceptin) for the treatment of metastatic breast cancer in patients w/ tumors that over-express HER-2 & have not received previous chemotherapy for their metastatic disease.

Premed: Dexamethasone 20 mg orally 12 & 6 hr prior to infusion; promethazine 25-50 mg IV or other suitable H₁-antagonist 30 min prior to infusion; cimetidine 300 mg or ranitidine 50 mg IV infusion over 15 min, starting 30 min prior to infusion. Primary treatment of ovarian cancer 175 mg/m² IV over 3 hr followed by cisplatin 75 mg/m², repeated every 3 wk or 135 mg/m² IV over 24 hr followed by cisplatin 75 mg/m², repeated every 3 wk. Metastatic ovarian or breast cancer 175 mg/m² as single IV infusion over 3 hr, repeated every 3 wk as tolerated. Primary or secondary treatment of NSCLC 175 mg/m² IV over 3 hr w/ a 3 wk interval between courses. Node +ve breast cancer 175 mg/m² IV over 3 hr every 3 wk for 4 courses following doxorubicin & cyclophosphamide combination therapy. Over-expression of HER-2 breast cancer 175 mg/m² IV over 3 hr w/ a 3 wk interval between courses for 6 cycles + Herceptin 2 mg/kg IV once a wk until progression of disease after an initial loading dose of 4 mg/kg.

Hypersensitivity to paclitaxel or other taxanes, & PEG 35 castor oil or drugs formulated in PEG 35 castor oil (eg, cyclosporine & teniposide for inj conc). Patients w/ solid tumors who have a baseline neutrophil counts of <1.5 x 10⁹ cells/L.

Cross-hypersensitivity w/ other taxanes. Patients should be under continuous observation for at least the 1st 30 min following the start of the infusion & frequently thereafter; discontinue immediately in case of a severe hypersensitivity reaction. Do not administer by intracerebral, intrapleural or IP routes; must be diluted before IV infusion. Should be given before a platinum compd when given in combination. Premed before each treatment cycle w/ corticosteroids (eg, dexamethasone), antihistamines (eg, diphenhydramine or promethazine) & an H₂-receptor antagonist (eg, cimetidine or ranitidine) to minimize the possibility of hypersensitivity reactions. Do not administer to patients w/ a pre-treatment neutrophil count of <1.5 x 10⁹ cells/L or platelet count of <100 x 10⁹ cells/L. Reduce dose by 20% in subsequent cycles if there is severe neutropenia during the course of treatment (ie, neutrophil count <0.5 x 10⁹ cells/L). Previous RT may induce more severe myelosuppression. ECG monitoring for patients w/ serious conduction abnormalities & for those who develop abnormal CV symptoms or signs during vital signs monitoring. Severe CV events were observed more frequently in patients w/ NSCLC than breast or ovarian cancer. Monitor cardiac function when used in combination w/ trastuzumab or doxorubicin for the treatment of metastatic breast cancer; patients should undergo baseline cardiac assessment including history, physical exam, ECG, echocardiogram, &/or MUGA scan. Cardiac function should be further monitored during treatment (eg, every 3 mth). Exclude bowel perforation in patients w/ abdominal pain. Patients w/ preexisting neuropathy; reduce dose by 20% if peripheral neuropathy develops during therapy. Greater incidence of neurotoxicity when used in combination w/ cisplatin in NSCLC patients. Development of interstitial pneumonia when in combination w/ lung radiation. Consider pseudomembranous colitis in the differential diagnosis of cases of severe or persistent diarrhea occurring during or shortly after treatment. Severe mucositis. Prompt & complete ophth exam in patients w/ visual impairment; discontinue if cystoid macular edema diagnosis is confirmed. Frequently monitor blood counts during treatment; vital signs particularly during the 1st hr of infusion. Closely monitor the infusion site for possible infiltration during drug administration. Contains ethanol; consider possible CNS & other effects of alcohol. Patients should refrain from driving or using machines. Increased myelosuppression when given as a 24-hr infusion to patients w/ moderate to severe hepatic impairment. Renal impairment. May impair fertility in females & males of reproductive potential. Women of childbearing potential should use effective contraception throughout therapy & for at least 6 mth after the last dose. Males should use effective contraception to avoid fathering a child during treatment & for at least 3 mth of the last dose. Pregnancy. Discontinue during lactation. Childn <18 yr. Elderly.

Hypotension; myelosuppression, thrombocytopenia, leukopenia, fever, bleeding, anemia, neutropenia; elevated alkaline phosphatase, AST & ALT; flushing, rash; infection; nausea, vomiting, diarrhea, mucositis; arthralgia, myalgia; peripheral neuropathy; alopecia. Bradycardia, ECG abnormalities (non-specific repolarization & sinus tachycardia); febrile neutropenia (associated w/ an infectious episode including UTI & URTI); elevated bilirubin; dyspnea, chest pains, tachycardia; inj site reactions (including localized edema, pain, erythema, induration, cellulitis).

Decreased clearance w/ prior administration of cisplatin. May increase plasma levels of doxorubicin. Elevated mean serum trough conc of trastuzumab. Higher incidence of arthralgia or myalgia w/ filgrastim. Concomitant use w/ 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.

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