Ebetaxel

Ebetaxel

paclitaxel

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
1st-line treatment of advanced ovarian cancer or residual tumours after preceding laparotomy, in combination w/ cisplatin. 2nd-line chemotherapy of metastatic ovarian cancer in patients who have failed conventional therapeutic treatment w/ platinum-containing agents. Initial treatment of advanced or metastatic breast cancer in combination w/ trastuzumab in patients overexpressing HER-2 at 3+ level for whom anthracycline therapy is not indicated. As single agent for the treatment of metastatic breast cancer in patients where standardised anthracycline therapy has either failed or is not suitable. In combination w/ cisplatin for the treatment of non-small cell lung cancer (NSCLC) in patients for whom a potentially curative surgical treatment &/or radiation therapy is not suitable.
Dosage/Direction for Use
Pre-medication w/ dexamethasone 20 mg orally approx 12 & 6 hr before therapy & diphenhydramine 50 mg IV 30-60 min before therapy & cimetidine 300 mg IV or ranitidine 50 mg IV 30-60 min before therapy. 1st-line chemotherapy of ovarian cancer 175 mg/m2 IV over 3 hr followed by cisplatin 75 mg/m2 every 3 wk, or 135 mg/m2 as an infusion over 24 hr followed by cisplatin 75 mg/m2. A therapy-free interval of 3 wk is recommended between therapy courses. 2nd-line chemotherapy of ovarian cancer 175 mg/m2 administered as a 3-hr infusion w/ an interval of 3 wk between therapy courses. 1st-line chemotherapy of breast cancer In combination w/ doxorubicin: 220 mg/m2 IV over 3 hr, w/ 3-wk interval between courses. Administer 24 hr after doxorubicin. In combination w/ trastuzumab: 175 mg/m2 IV over 3 hr, w/ 3-wk interval between therapy courses. 2nd-line chemotherapy of breast cancer 175 mg/m2 BSA over 3 hr, w/ 3-wk interval between therapy courses. Treatment of advanced NSCLC 175 mg/m2 over 3 hr followed by cisplatin 80 mg/m2 w/ an interval of 3 wk between therapy courses.
Contraindications
Hypersensitivity. Initial neutrophil count <1,500 cells/mm3. Pregnancy & lactation.
Special Precautions
Discontinue in case of severe hypersensitivity reactions. Frequently monitor haematological parameters & vital parameters. Perform careful monitoring of cardiac function. Peripheral neuropathy; neurotoxicity. Hepatic impairment. Contains ethanol. Avoid intraarterial application. May contribute to the development of interstitial pneumonitis if used w/ radiation therapy on the lungs. Childn <18 yr.
Adverse Reactions
Infection (mainly UTI & upper resp tract infections), w/ reported cases of fatal outcome; myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopenia, bleeding; minor hypersensitivity reactions (mainly flushing & rash); neurotoxicity (mainly: peripheral neuropathy); hypotension; diarrhoea, vomiting, nausea, mucosal inflammation; alopecia; arthralgia, myalgia. Bradycardia; transient & mild nail & skin changes; inj site reactions; severe elevation in AST (SGOT), severe elevation in alkaline phosphatase.
Drug Interactions
Increase in myelotoxicity, 20% decrease in clearance & increase in risk of renal failure w/ cisplatin. Reduced elimination of doxorubicin & its active metabolites.
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 inj 100 mg/16.6 mL
Packing/Price
1's
Form
Ebetaxel inj 30 mg/5 mL
Packing/Price
1's
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