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Brand Name, Dosage Format and Strength
Biomedis Paclitaxel 100 mg/16.7 mL vial Solution for Intravenous Infusion
Therapeutic Category
Oncology
Class
Antineoplastic Adjunct, Platinum Alkaloids, Alkylating Agent, Taxanes, Topoisomerase II Inhibitor, Antimetabolite, Platinum Alkaloids, Taxanes , Nonsteroidal Antiandrogen
DOSAGE AND ADMINISTRATION
Premedication Regimen
Premedicate all patients with oral dexamethasone (20 mg) approximately 12 and 6 hrs before paclitaxel administration, IV diphenhydramine or its equivalent (50 mg) 30 to 60 mins before paclitaxel, and either IV cimetidine (300 mg) or IV ranitidine (50 mg) 30 to 60 mins before paclitaxel in order to reduce the incidence of hypersensitivity reactions.
Patients with HIV infection may follow the same premedication regimen with the exception of a reduced dose of oral dexamethasone (10 mg).
Paclitaxel Injection must be diluted prior to IV infusion.
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Indications |
Recommended Paclitaxel IV Infusion Regimen |
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Ovarian Cancer |
Previously untreated patients with ovarian cancer: Paclitaxel 175 mg/m2 administered IV over 3 hrs followed by cisplatin 75 mg/m2 ; may be given every 3 wks, OR Paclitaxel 135 mg/m2 administered IV over 24 hrs followed by cisplatin 75 mg/m2 ; may be given every 3 wks. |
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Previously chemotherapy-treated ovarian cancer patients: Paclitaxel 135 or 175 mg/m2 administered IV over 3 hrs; given every 3 wks. |
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Breast Cancer |
Adjuvant treatment of node positive breast cancer: Paclitaxel 175 mg/m2 administered IV over 3 hrs given every 3 wks for 4 courses administered sequentially to doxorubicin-containing combination therapy. |
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After failure of initial chemotherapy for metastatic disease or relapse within 6 mos of adjuvant chemotherapy: Paclitaxel 175 mg/m2 administered IV over 3 hrs given every 3 wks. |
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For overexpression of HER-2 breast cancer: Paclitaxel 175 mg/m2 administered IV over 3 hrs; given every 3 wks for 6 cycles. Administer trastuzumab 2 mg/kg IV once a wk until progression of disease after an initial loading dose of 4 mg/kg body weight. |
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NSCLC |
Paclitaxel 135 mg/m2 administered IV over 24 hrs followed by cisplatin 75 mg/m2 ; given every 3 wks. |
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AIDS-related Kaposi’s Sarcoma |
Paclitaxel 135 mg/m2 administered IV over 3 hrs given every 3 wks, OR Paclitaxel 100 mg/m2 administered IV over 3 hrs given every 2 wks (dose intensity 45-50 mg/m2 per wk)
3 wks was shown to be more toxic.
< 500 cells/mm3 for a wk or longer)
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Or, as prescribed by a physician |
Preparation for IV Infusion
Administer through an in-line filter with a microporous membrane not greater than 0.22 micron.
Paclitaxel for injection must be diluted prior to use for IV infusion to produce a solution containing 0.3 to 1.2 mg of paclitaxel per mL. Compatible solutions are as follows: 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, and 5% dextrose in Ringer’s injection.
Paclitaxel solution, when diluted as recommended, is stable for 27 hrs at 25°C under ambient lighting conditions in glass or polypropylene bottles or in plastic (polypropylene or polyolefin) bags.
Visually inspect paclitaxel solution for particulate matter or discoloration prior to use. The resulting solution may not be clear due to the product’s vehicle. However, no clinically important loss in potency has been noted after delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.
Several factors such as concentration of the drug, specific diluent used, resulting pH and temperature, affect the physical and/or chemical compatibility of paclitaxel.
Incompatibilities
Undiluted paclitaxel should not come in contact with plasticized polyvinyl chloride (PVC) equipment or devices. Paclitaxel should preferably be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-covered administration sets to avoid leaching from PVC infusion bags or sets.
Paclitaxel solutions are reported to be physically incompatible with the following drugs: amphotericin B, chlorpromazine HCl, hydroxyzine HCl, methylprednisolone, sodium succinate, and mitoxantrone HCl.
Paclitaxel is compatible with doxorubicin for at least 24 hrs but microcrystalline precipitation occurred after 3 to 5 days.
General Dosing Information
- For patients with solid tumors (ovary, breast, NSCLC), paclitaxel courses should not be repeated until the patient’s neutrophil count is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3.
- Reduce dose by 20% for subsequent courses of paclitaxel in patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a wk or longer) or severe peripheral neuropathy during paclitaxel therapy.
- Patients who experience minor symptoms such as flushing, skin reactions, dyspnea, hypotension, or tachycardia do not require interruption of therapy. However, patients should immediately discontinue therapy if severe reactions occur such as hypotension requiring treatment, dyspnea requiring bronchodilators, angioedema or generalized urticaria. Patients should be treated with epinephrine, IV fluids, and additional doses of antihistamine (e.g., diphenhydramine) and corticosteroid.
- Monitor vital signs regularly, particularly during the first hr of administration. Cardiac monitoring is not required except in patients with preexisting cardiac abnormalities.
- Closely monitor the infusion site for possible infiltration during drug administration particularly during longer periods of infusion (e.g., 24 hrs). Local reactions may appear 7 to 10 days after completion of paclitaxel infusion.
Handling and Disposal Precautions
- Use protective gloves when handling paclitaxel solution for injection since skin reactions (e.g., tingling, burning, erythema) may occur with accidental exposure to the drug.
- Wash the affected area immediately and thoroughly with soap and water if paclitaxel comes in contact with skin / mucous membrane.
- Avoid inhalation during preparation and administration of paclitaxel solutions. Inhalation may cause dyspnea, chest pain, burning eyes, sore throat, and nausea.