Anzatax

Anzatax

paclitaxel

Manufacturer:

Hospira

Distributor:

Hospira
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
Primary treatment of ovarian cancer in combination w/ a platinum agent. Metastatic ovarian & breast cancer after failure of standard therapy. Non-small lung cancer (NSCLC). Adjuvant treatment of node +ve breast cancer administered sequentially to doxorubicin & cyclophosphamide. In combination w/ trastuzumab (Herceptin) for metastatic cancer of the breast, in patients who have tumors that over-express HER-2 & who have not received previous chemotherapy for their metastatic disease.
Dosage/Direction for Use
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, 30 min prior to infusion. 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.
Contraindications
Hypersensitivity to paclitaxel & PEG 35 castor oil or drugs formulated in PEG 35 castor oil (eg, cyclosporin & teniposide for inj concentrate). Patients w/ solid tumors who have baseline neutrophil counts of <1.5 x 109 cells/L.
Special Precautions
Do not administer by intracerebral, intrapleural or intraperitoneal routes. Cross-hypersensitivity w/ other taxanes; closely monitor patients w/ a previous history of hypersensitivity to 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 if severe hypersensitivity reaction occurs. Should be given before a platinum compd when given in combination. Premed w/ corticosteroids (eg, dexamethasone), antihistamines (eg, diphenhydramine or promethazine) & H2-receptor antagonist (eg, cimetidine or ranitidine) is needed before every treatment cycle in order to minimize the possibility of hypersensitivity reactions. Not to be administered 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 a course of treatment (ie, neutrophil count <0.5 x 109 cells/L). Exclude bowel perforation in patients w/ abdominal pain. Patients w/ preexisting neuropathy; 20% dose reduction in patients who develop peripheral neuropathy during therapy. Greater incidence of neurotoxicity when used in combination w/ cisplatin in NSCLC patients. Frequently monitor blood counts during treatment; vital signs particularly during the 1st hr of infusion. Monitor ECG in patients w/ serious conduction abnormalities & for 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 the infusion site for possible infiltration during drug administration. Contains alcohol; consideration should be given to possible CNS & other effects of alcohol. Renal & hepatic impairment. Should use effective contraception in women of childbearing potential throughout therapy & for at least 6 mth after the last dose; males should avoid fathering a child during treatment & for at least 3 mth of the last dose. Pregnancy. Discontinue during lactation. Childn. Elderly.
Adverse Reactions
Hypotension; myelosuppression, thrombocytopenia, leucopenia, 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).
Drug Interactions
Decreased clearance w/ cisplatin. May inhibit metabolism w/ ketoconazole & drugs metabolized in the liver (eg, erythromycin). May increase plasma levels of/ doxorubicin. Elevated mean serum trough conc of trastuzumab. Higher incidence of arthralgia or myalgia w/ filgrastim.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of plant alkaloids and other natural products, taxanes. Used in the treatment of cancer.
Presentation/Packing
Form
Anzatax soln for IV infusion 100 mg/16.7 mL
Packing/Price
1's
Form
Anzatax soln for IV infusion 150 mg/25 mL
Packing/Price
1's
Form
Anzatax soln for IV infusion 30 mg/5 mL
Packing/Price
1's
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