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PACLITAXEL

Package(a):
VIALS (solution for injection): 10 x 5 ml.
Dosage(a):
All patients should be premedicated prior to administration in order to prevent hypersensitivity reactions. Premedication may consist of dexamethasone 20 mg orally (or its equivalent) approximately 6-12 hours before administration, diphenhydramine 50 mg I.V. (or its equivalent) 30-60 minutes before administration, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30-60 minutes before administration. 
Must be diluted prior to infusion. 
Advanced carcinoma of the ovary: Previously untreated patients: I.V. administration at 21 day intervals by a continuous infusion over 24 hours at a dose of 135 mg/m²followed by a dose of 75 mg/m². In patients previously treated using chemotherapy: Administration at 21 day intervals over 3 hours at a dose of 135 mg/m² or 175 mg/m².
Adjuvant treatment of node-positive breast cancer: I.V. administration at 21 day intervals, by continuous infusion over 3 hours at a dose of 175 mg/m², for four courses administered sequentially to doxorubicin-containing combination therapy.
Breast carcinoma: I.V. by continuous infusion over 3 hours at a dose of 175 mg/m² at 21 day intervals. 
Non-small cell lung carcinoma: I.V. by continuous infusion over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75 mg/m² at 21 day intervals. 
AIDS related Kaposi’s sarcoma: I.V. at either 21 day intervals over 3 hours at a dose of 135 mg/m² or at 14 day intervals over 3 hours at a dose of 100 mg/m² (dose intensity 45-50 mg/m²/week). Patient showing signs of immunosuppression: See prescribing information for full details. 
Gastric carcinoma: 210 mg/m² administered I.V. over 3 hours every 3 weeks. Decrease according to patient’s age and performance status. 
Single courses should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³. See prescribing information for full details.
Prescribing Restrictions:  None

Package(b):
VIALS (solution for injection): 5 x 16.7 ml.
Dosage(b):
All patients should be premedicated prior to administration in order to prevent hypersensitivity reactions. Premedication may consist of dexamethasone 20 mg orally (or its equivalent) approximately 6-12 hours before administration, diphenhydramine 50 mg I.V. (or its equivalent) 30-60 minutes before administration, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30-60 minutes before administration. 
Must be diluted prior to infusion. 
Advanced carcinoma of the ovary: Previously untreated patients: I.V. administration at 21 day intervals by a continuous infusion over 24 hours at a dose of 135 mg/m²followed by a dose of 75 mg/m². In patients previously treated using chemotherapy: Administration at 21 day intervals over 3 hours at a dose of 135 mg/m² or 175 mg/m².
Adjuvant treatment of node-positive breast cancer: I.V. administration at 21 day intervals, by continuous infusion over 3 hours at a dose of 175 mg/m², for four courses administered sequentially to doxorubicin-containing combination therapy.
Breast carcinoma: I.V. by continuous infusion over 3 hours at a dose of 175 mg/m² at 21 day intervals. 
Non-small cell lung carcinoma: I.V. by continuous infusion over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75 mg/m² at 21 day intervals. 
AIDS related Kaposi’s sarcoma: I.V. at either 21 day intervals over 3 hours at a dose of 135 mg/m² or at 14 day intervals over 3 hours at a dose of 100 mg/m² (dose intensity 45-50 mg/m²/week). Patient showing signs of immunosuppression: See prescribing information for full details. 
Gastric carcinoma: 210 mg/m² administered I.V. over 3 hours every 3 weeks. Decrease according to patient’s age and performance status. 
Single courses should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³. See prescribing information for full details.
Prescribing Restrictions:    

Package(c):
VIALS (solution for injection): 4 x 50 ml.
Dosage(c):
All patients should be premedicated prior to administration in order to prevent hypersensitivity reactions. Premedication may consist of dexamethasone 20 mg orally (or its equivalent) approximately 6-12 hours before administration, diphenhydramine 50 mg I.V. (or its equivalent) 30-60 minutes before administration, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30-60 minutes before administration. 
Must be diluted prior to infusion. 
Advanced carcinoma of the ovary: Previously untreated patients: I.V. administration at 21 day intervals by a continuous infusion over 24 hours at a dose of 135 mg/m²followed by a dose of 75 mg/m². In patients previously treated using chemotherapy: Administration at 21 day intervals over 3 hours at a dose of 135 mg/m² or 175 mg/m².
Adjuvant treatment of node-positive breast cancer: I.V. administration at 21 day intervals, by continuous infusion over 3 hours at a dose of 175 mg/m², for four courses administered sequentially to doxorubicin-containing combination therapy.
Breast carcinoma: I.V. by continuous infusion over 3 hours at a dose of 175 mg/m² at 21 day intervals. 
Non-small cell lung carcinoma: I.V. by continuous infusion over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75 mg/m² at 21 day intervals. 
AIDS related Kaposi’s sarcoma: I.V. at either 21 day intervals over 3 hours at a dose of 135 mg/m² or at 14 day intervals over 3 hours at a dose of 100 mg/m² (dose intensity 45-50 mg/m²/week). Patient showing signs of immunosuppression: See prescribing information for full details. 
Gastric carcinoma: 210 mg/m² administered I.V. over 3 hours every 3 weeks. Decrease according to patient’s age and performance status. 
Single courses should not be repeated until the neutrophil count is at least 1,500 cells/mm³ and the platelet count is at least 100,000 cells/mm³. See prescribing information for full details.
Prescribing Restrictions:   


Indications:
Alone or in combination, for the treatment of advanced carcinoma of the ovary. 
For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 
For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. 
Associated with cisplatin for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. 
In the second-line treatment of AIDS related Kaposi's sarcoma. 
For the treatment of advanced gastric carcinoma.
Contra-Indications:
History of severe hypersensitivity reactions to paclitaxel or other drugs formulated in polyethoxylated castor oil. Severe baseline neutropenia (<1,500 cells/mm³.)
Special Precautions:
Should be administered under the supervision of a physician experienced in the use of cancer chemotherapy agents. See prescribing information for full details. Should be given before a platinum compound when it is given in combination with a platinum compound. Frequent monitoring of vital signs is recommended, particularly during the first hour of infusion. Possibility of CNS and other effects. 
Pregnancy and lactation: Women of childbearing potential should be advised to avoid becoming pregnant during therapy. Breastfeeding should be discontinued for the duration of therapy. 
Pediatric use: The safety and effectiveness have not been established.
Side Effects:
See prescribing information for full details.
Drug Interactions:
Doxorubicin, cisplatin.