1
INDICATIONS AND USAGE
Docetaxel is a microtubule inhibitor indicated for:
1.1. Ovarian cancer:
Paclitaxel Injection is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection is indicated in combination with cisplatin.
1.2. Breast cancer:
Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
1.3. Non-small cell lung cancer:
Paclitaxel Injection in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
1.4. AIDS-related Kaposi’s sarcoma:
Paclitaxel Injection is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.
1.5. Un-labeled uses:
Treatment of bladder, cervical, small cell lung, and head and neck cancers; treatment of (unknown primary) adenocarcinoma.
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DOSAGE AND ADMINISTRATION
For patients with carcinoma of the ovary, the following regimens are recommended:
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For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered.
1 Paclitaxel administered intravenously over 3 hours at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg /m2; or
2 Paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2.
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In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is paclitaxel 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.
For patients with carcinoma of the breast, the following regimens are recommended:
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For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel, at a dose of 175 mg/m2 intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide.
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After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel at a dose of 175 mg/m2 administered intravenously over 3 hours every 3 weeks has been shown to be effective.
For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin, 75 mg/m2.
For patients with AIDS-related Kaposi’s sarcoma, paclitaxel administered at a dose of 135 mg/m2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45 to 50 mg/m2/week). In the 2 clinical trials evaluating these schedules, the former schedule (135 mg/m2 every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m2 every 2 weeks). Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
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Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);
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Initiate or repeat treatment with Paclitaxel Injection only if the neutrophil count is at least 1000 cells/mm3;
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Reduce the dose of subsequent courses of Paclitaxel Injection by %20 for patients who experience severe neutropenia (neutrophil <500 cells/ mm3 for a week or longer); and
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Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.
For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel injection should not be repeated until the neutrophil count is at least 1500 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
Paclitaxel Injection should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/ mm3. Patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer) or severe peripheral neuropathy during paclitaxel injection therapy should have dosage reduced by %20 for subsequent courses of paclitaxel injection. The incidence of neurotoxicity and the severity of neutropenia increase with dose.
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PREPARATION AND ADMINISTRATION PRECAUTIONS:
Procedures for proper handling and disposal of anticancer drugs should be considered. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Paclitaxel Injection. If Paclitaxel Injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If Paclitaxel Injection contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.
5
COMPATIBILITY
5.1. Stability:
Paclitaxel Injection is stable in D5W, NS, D5S.
5.2. Y-site administration:
Compatible: Acyclovir, amikacin, aminophylline, ampicillin/sulbactam, anidulafungin, bleomycin, butorphanol, calcium chloride, carboplatin, cefepime, cefotetan, ceftazidime, cimetidine, cisplatin, cladribine, cyclophosphamide, cytarabine, dacarbazine, dexamethasone sodium phosphate, diphenhydramine, doripenem, doxorubicin, droperidol, etoposide, etoposide phosphate, famotidine, floxuridine, fluconazole, zhaloperidol, heparin, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydromorphone, ifosfamide, linezolid, lorazepam, magnesium sulfate, mannitol, meperidine, mesna, methotrexate, metoclopramide, morphine, nalbuphine, ondansetron, ondansetron with ranitidine, oxaliplatin, palonosetron, pemetrexed, pentostatin, potassium chloride, prochlorperazine edisylate, propofol, ranitidine, sodium bicarbonate, thiotepa, topotecan, vancomycin, vinblastine, vincristine, zidovudine.
Incompatible: AmphotericinB, amphotericin B cholesteryl sulfate complex, chlorpromazine,
doxorubicin liposome, hydroxyzine, methylprednisolone sodium succinate, mitoxantrone.
Variable (consult detailed reference):
Ceftriaxone.
5.3. Compatibility in syringe:
Incompatible: Ceftriaxone.