Ebetaxel (Paclitaxel Ebewe)

Ebetaxel (Paclitaxel Ebewe)

paclitaxel

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
Ovarian carcinoma: 1st-line chemotherapy in patients w/ advanced or w/ residual disease (>1 cm) after initial laparotomy in combination w/ cisplatin. 2nd-line chemotherapy in ovarian metastatic carcinoma after failure of standard, platinum-containing therapy. Breast carcinoma: Adjuvant in node-positive breast carcinoma following anthracycline & cyclophosphamide (AC) therapy. Initial treatment of locally advanced or metastatic breast cancer in combination w/ anthracycline or trastuzumab in patients who over-express HER2 at 3+ level. As single agent in metastatic breast carcinoma in patients who failed or are not candidates for standard, anthracycline-containing therapy. Advanced non-small cell lung carcinoma (NSCLC) in patients not candidates for potentially curative surgery &/or radiation therapy in combination w/ cisplatin. Advanced AIDS-related Kaposi's sarcoma (KS) in patients who have failed prior liposomal anthracycline therapy.
Dosage/Direction for Use
Premedication prior to paclitaxel administration: Dexamethasone 20 mg orally (8-20 mg for KS patient) approx 12 & 6 hr or IV for 30-60 min. Diphenhydramine or an equiv antihistamine (eg, chlorpheniramine) 50 mg IV for 30-60 min. Cimetidine 300 mg or ranitidine 50 mg IV for 30-60 min. Ovarian carcinoma: 1st-line chemotherapy 175 mg/m2 IV over 3 hr followed by cisplatin 75 mg/m2 every 3 wk. Alternatively, 135 mg/m2 in 24-hr infusion followed by cisplatin 75 mg/m2 w/ 3 wk interval between courses. 2nd-line chemotherapy 175 mg/m2 administered over 3 hr w/ 3 wk interval between courses. Breast carcinoma: Adjuvant chemotherapy 175 mg/m2 administered over 3 hr every 3 wk for 4 courses following AC therapy. 1st-line chemotherapy In combination w/ doxorubicin: 220 mg/m2 IV over 3 hr w/ 3-wk interval between courses administered 24 hr after doxorubicin 50 mg/m2. In combination w/ trastuzumab: 175 mg/m2 IV over 3 hr w/ 3-wk interval between courses administered the day following 1st dose or immediately after subsequent doses of trastuzumab, 2nd-line chemotherapy 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 as 3-hr IV infusion every 2 wk.
Contraindications
Hypersensitivity to paclitaxel or polyoxyethylated castor oil. Not to be used in patients w/ baseline neutrophils <1,500/mm3 (<1,000/mm3 for KS patients). KS patients suffering from concurrent, serious, uncontrolled infections. Lactation.
Special Precautions
Discontinue in case of severe hypersensitivity reactions. Avoid intra-arterial application. Pretreat patients w/ corticosteroids, antihistamines & H2-antagonists prior to treatment. Extravasation. Interstitial pneumonitis may develop in combination w/ radiation of lung. Frequently monitor blood counts, cardiac function (in severe conduction abnormalities), vital signs (particularly during 1st hr of infusion) & for development of profound myelosuppression. Reduce dose by 20% (25% in KS patients) if severe neutropenia or peripheral neuropathy occurs. Contains alcohol. Not to be used in severe hepatic impairment. Avoid pregnancy. Women & men should use contraception for at least 6 mth after treatment. Not recommended in childn <18 yr.
Adverse Reactions
Infection (urinary & upper resp tract infections); myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopenia, bleeding; hypersensitivity reactions (flushing & rash); neurotoxicity (peripheral neuropathy); hypotension; diarrhoea, vomiting, nausea, mucosal inflammation; alopecia; arthralgia, myalgia. Bradycardia; transient & mild nail & skin changes; inj site reactions (including localised oedema, pain, erythema, induration, cellulitis, skin fibrosis & necrosis); severe elevation in AST (SGOT) & alkaline phosphatase.
Drug Interactions
More profound myelosuppression & decreased clearance when given after cisplatin. Decreased elimination of doxorubicin. Toxicity may be increased w/ inhibitors of CYP2C8 or CYP3A4 eg, ketoconazole & other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir & nelfinavir. Efficacy may be compromised w/ inducers of CYP2C8 or CYP3A4 eg, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine. Systemic clearance may be lowered w/ nelfinavir & ritonavir.
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
Ebetaxel (Paclitaxel Ebewe) inj 100 mg/16.7 mL
Packing/Price
1's
Form
Ebetaxel (Paclitaxel Ebewe) inj 150 mg/25 mL
Packing/Price
1's
Form
Ebetaxel (Paclitaxel Ebewe) inj 30 mg/5 mL
Packing/Price
1's
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