Paxus PM

Paxus PM

paclitaxel

Manufacturer:

Samyang Holdings Corporation

Distributor:

Pacific Healthcare
Concise Prescribing Info
Contents
Paclitaxel
Indications/Uses
1st-line treatment of metastatic or recurrent breast cancer, & locally advanced or metastatic NSCLC.
Dosage/Direction for Use
Breast cancer Recommended dose: 300 mg/m2 via IV infusion over 3 hr every 3 wk. Premed: Administer approx 30 min prior to Paxus PM. Hydrocortisone 100 mg IV, pheniramine maleate 45.5 mg IV & cimetidine or ranitidine 300 mg or ranitidine 50 mg IV. Patient w/ febrile & severe neutropenia (<500 cells/mm3), thrombocytopenia (<50,000 cells/mm3) or grade 3 neurological toxicities Dose reduction to 240 mg/m2, may be further reduced to 190 mg/m2. NSCLC Initially 230 mg/m2 via IV infusion over 3 hr, followed by cisplatin 60 mg/m2 every 3 wk. Premed: Administer approx 30 min prior to Paxus PM. Hydrocortisone 100 mg IV, pheniramine maleate 45.5 mg IV, cimetidine 300 mg or ranitidine 50 mg IV. Ondansetron 8 mg IV may be administered as prophylactic anti-emetic prior to cisplatin administration. Patient w/ febrile & severe neutropenia (<500 cells/mm3), thrombocytopenia (<50,000 cells/mm3) for >1 wk or grade 2 neurological, hepatic, other non-hematological toxicities Reduce dose to 185 mg/m2, may be further reduced to 145 mg/m2.
Contraindications
Hypersensitivity. Severe myelosuppression (baseline neutrophil counts <1,500 cells/mm3). Patients who accompany infection. Pregnancy.
Special Precautions
Hypersensitivity. Immediately discontinue in severe hypersensitivity reactions. Do not administer to patients w/ baseline neutrophil counts <1,500 cells/mm3. Frequently check peripheral blood cell counts in order to monitor occurrence of myelotoxicity. Do not rechallenge therapy until recovery of neutrophils to 1,500 cells/mm3 & platelet level of 100,000 cells/mm3. Reduce dose by 20% when severe neutropenia (<500 cells/mm3) occurs; in moderate or severe peripheral neuropathy. Myelosuppression, interstitial pneumonia or pulmonary fibrosis. Closely monitor infusion site for possible infiltration during administration. Renal & moderate or severe hepatic impairment. Women of childbearing potential should avoid becoming pregnant. Discontinue lactation during therapy. Premature infant, newborn infant, infant, toddler or ped patients. Elderly.
Adverse Reactions
Neutropenia, leukopenia, thrombocytopenia, anemia; hypersensitivity reaction; peripheral neuropathy; myalgia, arthralgia; nausea, vomiting, diarrhea, constipation; alopecia; elevated bilirubin, alkaline phosphatase & AST (SGOT); edema, tenderness, skin reaction.
Drug Interactions
Decreased clearance & increased peripheral neuropathy w/ cisplatin. CYP2C8 & CYP3A4 substrates or inhibitors eg, ritonavir, saquinavir, indinavir & nelfinavir. Suppressed metabolism w/ vit A, azole antifungal agents (eg, ketoconazole, miconazole), macrolide hormones (eg, ethinyl estradiol), dihydropyridine Ca channel inhibitor (eg, nifedipine), terfenadine, cyclosporine, verapamil, quinidine, midazolam, phenacetin, ritonavir, saquinavir, indinavir & nelfinavir. Increased myelosuppression w/ RT & other antitumor drugs.
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
Paxus PM inj 100 mg/16.7 mL
Packing/Price
1's
Form
Paxus PM inj 30 mg/5 mL
Packing/Price
1's
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