Each ml contains Paclitaxel 6 mg, Dehydrated Alcohol IP 49.7% v/v, Polyoxyl 35 Castor Oil USNF q.s.
Without a Prescription
Paclitaxel is prescribed for:
Paclitaxel is indicated, after failure of first-line or subsequent chemotherapy for the treatment of metastatic carcinoma of the ovary.
Paclitaxel is prescribed for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Prior therapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel is prescribed for the second-line treatment of AIDS-related Kaposiís sarcoma.
All patients should be premedicated prior to Paclitaxel administration in order to prevent severe hypersensitivity reactions.
Such premedication may consist of dexamethasone 20 PO administered approximately 12 and 6 hours before Paclitaxel, diphenhydramine (or its equivalent) 50 mg I.V. 30 to 60 minutes prior to Paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before Paclitaxel.
In patients previously treated with chemotherapy for ovarian cancer, the recommended regimen is Paclitaxel 135 /m 2 or 175 mg/m 2 administered intravenously over 3 hours every 3 weeks.
For patients with carcinoma of the breast, Paclitaxel at a dose of 175 /m 2 administered intravenously over 3 hours every 3 weeks has been shown to be effective after failure of chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
For patients with AIDS-related Kaposiís sarcoma, Paclitaxel administered at a dose of 135 /m 2 given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m 2 given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45-50 mg/m 2 /week).
Based upon the immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
1. Reduce the dose of dexamethasone as one of the three premedication drugs to 10 PO (instead of 20 mg PO)
2. Initiate or repeat treatment with Paclitaxel only if the neutrophil count is at least 1000 cells/mm 3
3. Reduce the dose of subsequent courses of Paclitaxel by 20% for patients who experience severe neutropenia (neutrophil < 500 cells/mm 3 for a week or longer)
4. Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.
For the therapy of patients with solid tumors (ovary and breast), courses of Paclitaxel should not be repeated until the neutrophil count is at least 1,500 cells/mm 3 and the platelet count is at least 100,000 cells/mm 3 and Paclitaxel should not be given to patients with AIDS-related Kaposiís sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm 3.
Patients who experience severe neutropenia (neutrophil < 500 cells/mm 3 for a week or longer) or severe peripheral neuropathy during Paclitaxel therapy should have dosage reduced by 20% for subsequent courses of Paclitaxel. The incidence of neurotoxicity and the severity of neutropenia increase with dose.
Preparation and Administration Precautions
Paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling Paclitaxel.
The use of gloves is recommended.
If Paclitaxel solution contacts the skin, wash the skin immediately and thoroughly with soap and water, following topical exposure events have included tingling, burning and redness.
Preparation for Intravenous Administration
Paclitaxel must be diluted prior to infusion. Paclitaxel should be diluted in 0.9% Sodium Chloride Injection, USP 5% Dextrose Injection, USP or 5% Dextrose in Ringerís Injection to a final concentration of 0.3 to 1.2 /mL.
The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25 o C) and room lighting conditions.
No significant losses in potency have been noted following simulated delivery of the solution through I.V. tubing containing an in-line (0.22 micron) filter.
Paclitaxel is contraindicated if you have any of the following conditions:
Paclitaxel is contraindicated in patients who have a history of hypersensitivity reactions to Paclitaxel or other drugs formulated in Cremophorģ EL (polyoxyethylated castor oil).
Paclitaxel should not be used in patients with solid tumors who have baseline neutrophil counts of < 1500 cells/mm 3 or in patients with AIDS-related Kaposiís sarcoma (KS) with base-line neutrophil counts of < 1000 cells/mm 3 .
- Single dose vials of 5 ml,16.7 ml and 43.4 ml;