Claxel

Claxel

paclitaxel

Manufacturer:

Sichuan Huiyu

Distributor:

Oncolife Corp

Marketer:

Phil Pharmawealth
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
First-line chemotherapy of ovarian cancer in treatment w/ advanced carcinoma of ovary or w/ residual disease (>1 cm) after initial laparotomy in combination w/ cisplatin. Second-line chemotherapy of ovarian cancer in treatment of metastatic carcinoma of the ovary after failure of standard platinum containing therapy. Node +ve breast carcinoma following anthracycline & cyclophosphamide therapy. Initial treatment of locally advanced or metastatic breast cancer either in combination w/ anthracycline or trastuzumab in patients w/ over-express HER-2. Metastatic carcinoma of the breast who have failed or not candidate of anthracycline therapy. In combination of cisplatin in non-small cell lung carcinoma (NSCLC) who are not candidate for potential curative surgery &/or radiation therapy. Advanced AIDS-related Kaposi's sarcoma (KS) who have failed prior liposomal anthracycline therapy.
Dosage/Direction for Use
Premed w/ oral dexamethasone 20 mg approx 12 & 6 hr or IV 30-60 min; diphenhydramine 50 mg for 30-60 min; IV cimetidine 300 mg or IV ranitidine 50 mg for 30-60 min. IV First-line chemotherapy of ovarian carcinoma Paclitaxel 175 mg/m2 over 3 hr, followed by cisplatin at 75 mg/m2 every 3 wk or 135 mg/m2 in a 24-hr infusion followed by cisplatin 75 mg/m2 w/ 3 wk interval. Second-line chemotherapy of ovarian carcinoma 175 mg/m2 over 3 hr, w/ 3 wk interval. Adjuvant chemotherapy in breast carcinoma 175 mg/m2 over 3 hr every 3 wk for 4 courses, following anthracycline therapy. First-line chemotherapy of breast carcinoma Recommended dose: 220 mg/m2 over 3 hr w/ 3 wk interval. Administered 24 hr after 50 mg/m2 in combination w/ doxorubicin. 175 mg/m2 over 3 hr w/ 3 wk interval in combination w/ trastuzumab. Paclitaxel infusion may be started the day following the 1st dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab is tolerated. Second-line chemotherapy of breast carcinoma 175 mg/m2 over 3 hr, every 3 wk. Treatment of advanced NSCLC 175 mg/m2 over 3 hr, followed by cisplatin 80 mg/m2, w/ every 3 wk interval. Treatment of AIDS-related KS 100 mg/m2 over 3 hr infusion every 2 wk. Subsequent doses of paclitaxel should be administered according to individual patient tolerance. Patients w/ severe neutropenia (<500/mm3 for ≥7 days) or severe peripheral neuropathy: Reduce dose of 20% for subsequent courses (25% for KS patients & w/ metastatic disease). Patients w/ mucositis (grade 2 or worse) during paclitaxel therapy: Reduced dose by 25% for subsequent courses of paclitaxel.
Contraindications
Hypersensitivity. Patients w/ baseline neutrophils <1,500/mm3 (<1,000/mm3 for KS patients). In KS: Patients w/ concurrent, serious, uncontrolled infections. Pregnancy & lactation.
Special Precautions
Closely monitor infusion site for possible infiltration & extravasation. Should be given before cisplatin when used in combination.
Adverse Reactions
Infection (mainly urinary tract & upper resp tract infections), flu syndrome, septic shock, pneumonia peritonitis, sepsis; myelosuppression, neutropenia, anemia, thrombocytopenia, leucopenia, bleeding, neutropenic fever, severe anemia, febrile neutropenia, acute myeloid leukemia, myelodysplastic syndrome; minor hypersensitivity reactions, significant hypersensitivity reactions requiring therapy, anaphylactic reactions/shock; wt gain/loss, anorexia, tumor lysis syndrome; confusional stage; neurotoxicity, paresthesia, somnolence, depression, severe neuropathy, nervousness, insomnia, hypokinesia, abnormal gait/thinking, hypoesthesia, taste change, motor neuropathy (w/ resultant minor distal weakness), autonomic neuropathy, grand mal seizures, convulsions, encephalopathy, dizziness, headache, ataxia; dry eyes, amblyopia, visual field defect, optic nerve &/or visual disturbances (scintillating scotoma), macular oedema, photopsia, vitreous floaters; ototoxicity, hearing loss, tinnitus, vertigo; bradycardia, tachycardia, palpitation, syncope, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia w/ bigeminy, AV block & syncope, MI, CHF, cardiac failure, atrial fibrillation, supraventricular tachycardia; hypotension, vasodilation, HTN, thrombosis, thrombophlebitis, shock, phlebitis; epistaxis, dyspnea, pleural effusion, interstitial pneumonia, lung fibrosis, pulmonary embolism, resp failure, cough, pulmonary HTN; nausea, vomiting, diarrhea, mucosal inflammation, stomatitis, abdominal pain, dry mouth, mouth ulceration, melena, dyspepsia, bowel obstruction/perforation, ischemic colitis, pancreatitis, mesenteric thrombosis, pseudomembranous colitis, esophagitis, constipation, ascites, neutropenic colitis; hepatic necrosis/encephalopathy; alopecia, transient & mild nail & skin changes, changes in nail pigmentation or discoloration of nail bed, pruritus, rash, erythema, Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, urticaria, onycholysis, folliculitis, scleroderma; arthralgia, myalgia, bone pain, leg cramps, myasthenia, back pain, SLE; dysuria; asthenia, pain, oedema including peripheral & face, inj site reactions, chest pain, chills, asthenia, pyrexia, dehydration, oedema, malaise.
Drug Interactions
20% decrease clearance & more profound myelosuppression after w/ cisplatin. Increased risk of renal failure w/ cisplatin. Reduced elimination & active metabolites w/ doxorubicin. Inhibition w/ erythromycin, fluoxetine, gemfibrozil or induce w/ rifampicin, carbamazepine, phenytoin, phenobarb, efavirenz, nevirapine either CYP2C8 or CYP3A4. Decrease in systemic clearance w/ nelfinavir & ritonavir. Concomitant use w/ PIs.
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
Soln for IV infusion 6 mg/mL
Packing/Price
16.7 mL x 1's;5 mL x 1's;50 mL x 1's
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