Indications & Uses
Xelpac 260 is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
All patients should be premedicated prior to Paclitaxel administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before Paclitaxel, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to Paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before Paclitaxel.First-line treatment of ovarian cancer: Although alternative medication regimens for paclitaxel are under investigation at present, a combination therapy of paclitaxel and cisplatin is recommended. Depending on the duration of infusion, two different dosages are recommended for paclitaxel treatment: 175 mg/m2 of paclitaxel is administered as an intravenous infusion over a period of three hours followed thereafter by 75 mg/m2 of cisplatin and the therapy is repeated at 3-week intervals, or 135 mg/m2 of paclitaxel is administered as an intravenous infusion over a period of 24 hours followed thereafter by 75 mg/m2 of cisplatin and the therapy is repeated at 3-week intervals.Second-line treatment of ovarian cancer: The recommended dose of paclitaxel is 175 mg/m2 administered over 3 hours, with a 3-week interval between courses.Adjuvant chemotherapy in breast carcinoma: The recommended dose of paclitaxel is 175 mg/m2 administered over a period of 3 hours every 3 weeks for four courses, following AC therapy.First-line chemotherapy of breast carcinoma: When used in combination with doxorubicin (50 mg/m2), paclitaxel should be administered 24 hours after doxorubicin. The recommended dose of paclitaxel is 220 mg/m2 administered intravenously over a period of 3 hours, with a 3-week interval between courses. When used in combination with trastuzumab, the recommended dose of paclitaxel is 175 mg/m2 administered intravenously over a period of 3 hours, with a 3-week interval between courses. Paclitaxel infusion may be started the day following the first dose of trastuzumab or immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.Second-line chemotherapy of breast carcinoma: The recommended dose of paclitaxel is 175 mg/m2 administered over a period of 3 hours, with a 3-week interval between courses.Advanced non-small-cell lung cancer: The recommended dose of paclitaxel is 175 mg/m2 administered over 3 hours followed by 80 mg/m2 of cisplatin, with a 3-week interval between courses.Treatment of AIDS-related KS: The recommended dose of paclitaxel is 100 mg/m2 administered as a 3-hour intravenous infusion every two weeks.Dose adjustment: Subsequent doses of paclitaxel should be administered according to individual patient tolerance. Paclitaxel should not be re-administered until the neutrophil count is >1.5 x 109/1 (>1 x 109/1 for KS patients) and the platelet count is >100 x 109/1 (>75 x 109/1 for KS patients).
Side Effects
Common: Low blood counts leading to increased risk for infection, anemia and/or bleeding, hair loss, arthralgias and myalgias, pain in the joints and muscles, peripheral neuropathy, nausea, vomiting (usually mild), diarrhea, Mouth sores, hypersensitivity reaction, fever, facial flushing, chills, shortness of breath, or hives after Paxel is given.Rare: swelling of the feet or ankles (edema), liver problems, low blood pressure, darkening of the skin where previous radiation treatment has been given.
Cautions & Contraindications
Warnings & Precautions
Paxel should only be given under the supervision of a physician experienced in using cancer chemotherapy medicines. Because serious hypersensitivity reactions can occur, suitable supportive equipment must be on hand. As extravasation is possible, the infusion site should be watched closely for any sign of infiltration while the drug is being given. When Paxel is combined with cisplatin, Paxel should be given first. Serious hypersensitivity reactions, marked by breathing difficulty and low blood pressure needing treatment, angioedema, and widespread urticaria, have occurred in fewer than 1% of patients who received Paxel after adequate premedication. Fatal hypersensitivity reactions have occurred in some patients even with premedication. These reactions are probably histamine-mediated. If a severe hypersensitivity reaction occurs, the Paxel infusion must be stopped at once. Bone marrow suppression, mainly neutropenia, is the dose-limiting toxicity. The lowest neutrophil counts occurred at a median of 11 days. Blood counts should be checked frequently. Patients should not be treated again until the neutrophil count is at or above 1.5 x 109/l (at or above 1 x 109/l for KS patients) and the platelet count has recovered to at or above 100 x 109/l (at or above 75 x 109/l for KS patients). Severe abnormalities of cardiac conduction have rarely been reported with Paxel used alone. If a patient develops significant conduction abnormalities while receiving Paxel, appropriate treatment should be given, and continuous cardiac monitoring should be carried out during any later therapy with Paxel.
Contraindications
Paclitaxel must not be given to patients who have had severe hypersensitivity reactions to paclitaxel or to macrogolglycerol ricinoleate (polyoxyl castor oil). It is also contraindicated during lactation. Paclitaxel should not be used in patients whose baseline neutrophil count is below 1.5x109/l (below 1x109/l for KS patients) or whose platelet count is below 100x109/l (below 75x109/l for KS patients). In KS, paclitaxel is further contraindicated in patients with concurrent, serious, uncontrolled infections. Patients with severe hepatic impairment must not be treated with paclitaxel.