Zuellig Pharma


Concise Prescribing Info
1st-line therapy of advanced metastatic ovarian cancer in combination w/ a platinum agent. Metastatic ovarian cancer & breast cancer after failure of standard therapy. 1st-line therapy in combination w/ a platinum compd or as a single agent for non-small cell lung cancer (NSCLC) in patients who are not candidates for potentially curative surgery &/or radiation therapy. Adjuvant treatment of node positive breast cancer administered sequentially to doxorubicin & cyclophosphamide. 1st-line therapy of metastatic breast cancer in combination w/ trastuzumab (Herceptin) in patients who have tumors that over-express HER-2.
Dosage/Direction for Use
Premed: Dexamethasone 20 mg orally 12 hr & 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, 30 min prior to infusion. Primary treatment of ovarian cancer 175 mg/m2 IV infusion over 3 hr followed by cisplatin 75 mg/m2 repeated every 3 wk or 135 mg/m2 IV infusion over 24 hr followed by cisplatin 75 mg/m2 repeated every 3 wk. Metastatic ovarian or breast cancer 175 mg/m2 as a single agent IV infusion over 3 hr, repeated every 3 wk. Primary or secondary treatment of NSCLC 175 mg/m2 IV over 3 hr w/ a 3-wk interval between courses. Node positive 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. Paclitaxel may be started the day following the 1st dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose was well tolerated.
Not to be used in patients who have exhibited hypersensitivity reactions to paclitaxel; history of hypersensitivity reactions to PEG 35 castor oil or drugs formulated in PEG 35 castor oil (eg, cyclosporin & teniposide for inj conc). Patients w/ solid tumours who have a baseline neutrophil counts of <1.5 x 109 cells/L.
Special Precautions
Not to be administered by intracerebral, intrapleural or intraperitoneal routes. Must be diluted prior to IV infusion. Avoid contact w/ plasticised polyvinyl chloride (PVC) equipment, infusion lines or devices used when preparing infusion soln. Not recommended to repeat a course until patient's neutrophil count is at least 1.5 x 109 cells/L & platelet count is at least 100 x 109 cells/L. Reduce subsequent courses by 20% if severe neutropenia or severe peripheral neuropathy occur during therapy. Should be given before a platinum compd when given as combination. Premedicate before every treatment cycle w/ corticosteroids (eg, dexamethasone), antihistamines (eg, diphenhydramine or promethazine) & H2-receptor antagonist (eg, cimetidine or ranitidine). Not to be administered in patients w/ pre-treatment neutrophil count of <1.5 x 109 cells/L or platelet count <100 x 109 cells/L. Frequently monitor blood counts during treatment; vital signs particularly during 1st hr of infusion. Monitor ECG in patients w/ serious conduction abnormalities & those who develop abnormal CV symptoms or signs during vital signs monitoring. Monitor cardiac function when used in combination w/ trastuzumab or doxorubicin. Closely monitor patients w/ a previous history of hypersensitivity to other taxanes. Continuously observe patients receiving therapy for at least 1st 30 min following start of infusion & frequently thereafter. Discontinue immediately in case of severe hypersensitivity; patient should not be rechallenged. Exclude bowel perforation in patients w/ abdominal pain. Closely monitor infusion site for possible infiltration during administration. Carefully monitor patients w/ pre-existing neuropathy. Greater incidence of neurotoxicity when used in combination w/ cisplatin in NSCLC patients. Possible CNS & other effects of alcohol. May affect ability to drive & use machines. Renal & hepatic impairment. May impair fertility in females & males of reproductive potential. Use effective contraception; males should avoid fathering a child during treatment & at least 3 mth after last dose; women of childbearing potential should avoid becoming pregnant during treatment & for at least 6 mth after last dose. May cause foetal harm when administered to a pregnant woman. Discontinue breastfeeding while mother is undergoing treatment. Paed patients. Elderly.
Adverse Reactions
Hypotension; myelosupression, thrombocytopenia, leucopenia, 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 (including localised oedema, pain, erythema, induration, cellulitis).
Drug Interactions
Decreased clearance w/ prior administration of cisplatin. May inhibit the metabolism w/ ketoconazole & drugs metabolised in the liver (eg, erythromycin). May increase plasma levels of doxorubicin. Elevated mean serum trough conc of trastuzumab. Higher incidence of arthralgia or myalgia adverse events w/ filgastrim.
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Anzatax inj 100 mg/16.7 mL
Anzatax inj 300 mg/50 mL
Anzatax inj 150 mg/25 mL
Anzatax inj 30 mg/5 mL
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