Ildong Pharm


International Apex
Concise Prescribing Info
1st-line & subsequent therapy for the treatment of advanced carcinoma of the ovary in combination w/ cisplatin. Adjuvant treatment of node +ve administered sequentially to standard doxorubicin-containing combination chemotherapy.
Dosage/Direction for Use
Primary treatment of ovarian cancer 135 mg/m2 infused over 24 hr, followed by cisplatin & repeated at 3-wk intervals. Alternatively 175 mg/m2 may be infused over 3 hr followed by cisplatin every 3 wk. Secondary treatment of ovarian cancer 135 or 175 mg/m2 infused over 3 hr once every 3 wk. Breast cancer 175 mg/m2 infused over 3 hr once every 3 wk is recommended for adjuvant treatment (for 4 courses), for 2nd-line monotherapy & for 1st-line treatment w/ trastuzumab; paclitaxel is given the day after the 1st dose of trastuzumab or immediately after subsequent doses if well-tolerated. When used 1st-line w/ doxorubicin, paclitaxel 220 mg/m2 infused over 3 hr once every 3 wk; the dose is given 24 hr after doxorubicin. Non-small cell lung cancer 135 mg/m2 over 24 hr or 175 mg/m2 over 3 hr, followed by cisplatin & repeated at 3-wk intervals. AIDS related Kaposi's sarcoma (KS) 135 mg/m2 over 3 hr once every 3 wk. Alternatively, 100 mg/m2 over 3 hr every 2 wk may be given especially in patient w/ poor performance status.
Special Precautions
Severe hypersensitivity, anaphylaxis. Patients should be pretreated w/ corticosteroids, diphenhydramine & H2 antagonists to avoid fatal reactions. Neutropenia. Do not administer in patients w/ baseline neutrophil counts <1,500 cells/mm3 (<1,000 cells/mm3 for patients w/ KS). Frequent monitoring of blood counts should be instituted during treatment. Pregnancy & lactation.
Adverse Reactions
Bone marrow depression; peripheral neuropathy; hypersensitivity reactions w/ flushing, rash, dyspnoea, hypotension, chest pain & angioedema; alopecia, arthralgia & myalgia, GI disturbances, mucositis, bradycardia & ECG changes, nail dystrophies & elevation of liver enzyme values; infections.
Drug Interactions
Caution when in concomitant w/ CYP2C8 substrates (eg, repaglinide & rosiglitazone), inhibitors (eg, gemfibrozil) & inducers (eg, rifampin). Potential interactions w/ PIs (ritonavir, saquinavir, indinavir & nelfinavir).
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.
Apexel conc soln for IV infusion 6 mg/mL
100 mL x 1's;30 mL x 1's
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