Paxol

Paxol

paclitaxel

Manufacturer:

Venus Remedies

Distributor:

Unimed
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
In combination w/ cisplatin for 1st-line treatment of advanced ovarian cancer or residual disease (>1 cm) after initial laparotomy. 2nd-line chemotherapy of metastatic ovarian cancer after failure of standard platinum-based therapy. Adjuvant treatment of node +ve breast carcinoma following anthracycline & cyclophosphamide (AC) therapy. Initial treatment of locally advanced or metastatic breast cancer in combination w/ anthracycline or trastuzumab in patients overexpressing HER2 at 3+ level for whom anthracycline therapy is not suitable. Single agent for metastatic breast cancer in patients where standardised anthracycline therapy has either failed or is not appropriate. In combination w/ cisplatin for NSCLC in patients whom potentially curative surgical treatment &/or radiation therapy is not suitable. Advanced AIDS-related Kaposi's sarcoma (KS) who failed prior liposomal anthracycline therapy.
Dosage/Direction for Use
1st-line treatment of ovarian cancer 175 mg/m2 over 3 hr or 135 mg/m2 over 24 hr, followed 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 intervals between courses. Adjuvant chemotherapy in breast cancer 175 mg/m2 over 3 hr every 3 wk for 4 courses following AC therapy. 1st-line chemotherapy of breast cancer Combination w/ doxorubicin 50 mg/m2: 220 mg/m2 over 3 hr w/ 3-wk interval between courses, administered 24 hr after doxorubicin. Combination w/ trastuzumab: 175 mg/m2 over 3 hr w/ 3-wk interval between courses. 2nd-line chemotherapy of breast cancer 175 mg/m2 over 3 hr w/ 3-wk interval between courses. 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 over 3 hr every 2 wk.
Contraindications
Hypersensitivity w/ paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil). Patients w/ baseline neutrophils <1.5 x 109/L (<1 x 109/L for KS patients) or platelets <100 x 109/L (<75 x 109/L for KS patients). Concurrent, serious, uncontrolled infections in KS patients. Severe hepatic impairment. Lactation.
Special Precautions
Discontinue use if severe hypersensitivity reactions occur. Bone marrow suppression, severe cardiac conduction abnormalities, hypotension, HTN, bradycardia; peripheral neuropathy, severe neurotoxicity; alcoholism, epilepsy; pseudomembranous colitis; severe mucositis in KS patients. Ensure to premed w/ corticosteroids, antihistamines & H2-antagonists. Monitor blood counts frequently during therapy. Frequent vital signs monitoring during 1st hr of infusion. Perform baseline cardiac assessment including history, physical exam, ECG, echocardiogram &/or multigated acquisition scan. Monitor cardiac function every 3 mth during treatment. Avoid intra-arterial administration; extravasation. May promote development of interstitial pneumonitis w/ pulmonary RT. Hepatic disease; mild to moderate hepatic impairment. May affect male fertility. Male & female of childbearing potential should use effective contraception during & at least 6 mth after therapy. Not to be used during pregnancy. Not recommended in childn <18 yr.
Adverse Reactions
Infection; myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopenia, bleeding; minor hypersensitivity reactions; neurotoxicity; hypotension; nausea, vomiting, diarrhoea; alopecia; arthralgia, myalgia; mucosal inflammation. Bradycardia; transient & mild nail & skin changes; inj site reactions; severe AST/SGOT & alkaline phosphatase elevation.
Drug Interactions
Greater myelosuppression, 20% decreased clearance & increased risk of renal failure w/ cisplatin. Increased toxicity w/ CYP2C8 or CYP3A4 inhibitors (eg, ketoconazole & other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir) & inducers (eg, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine). Reduced elimination of doxorubicin & its active metabolites.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CD01 - paclitaxel ; Belongs to the class of taxanes from plant alkaloids and other natural products. Used in the treatment of cancer.
Presentation/Packing
Form
Paxol infusion conc 6 mg/mL
Packing/Price
1's
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