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Taxol Indications, Dosage, Storage, Stability - Paclitaxel

Taxol Indications, Dosage, Storage, Stability - Paclitaxel

INDICATIONS

TAXOL is indicated, after failure of first-line or subsequent chemotherapy for the treatment of metastatic carcinoma of the ovary.

TAXOL is indicated 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.

TAXOL is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.

DOSAGE AND ADMINISTRATION

Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted TAXOL solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylenelined administration sets.

All patients should be premedicated prior to TAXOL administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before TAXOL, diphenhydramine (or its equivalent) 50 mg I.V. 30 to 60 minutes prior to TAXOL, and cimetidine (300 mg) or ranitidine (50 mg) I.V. 30 to 60 minutes before TAXOL.

In patients with carcinoma of the ovary, TAXOL has been used at several doses and schedules; however, the optimal regimen is not yet clear. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES: Ovarian Carcinoma section.) In patients previously treated with chemotherapy for ovarian cancer, the recommended regimen is TAXOL 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.

For patients with carcinoma of the breast, TAXOL at a dose of 175 mg/m2 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 Kaposi’s sarcoma, TAXOL 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 45-50 mg/m2 /week). In the two clinical trials evaluating these schedules (see CLINICAL PHARMACOLOGY, CLINICAL STUDIES: AIDS-Related Kaposi’s Sarcoma section), 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:

  1. Reduce the dose of dexamethasone as one of the three premedication drugs to 10 mg PO (instead of 20 mg PO);
  2. Initiate or repeat treatment with TAXOL only if the neutrophil count is at least 1000 cells/ mm3;
  3. Reduce the dose of subsequent courses of TAXOL by 20% for patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer); and
  4. Initiate concomitant hematopoietic growth factor (G- CSF) as clinically indicated.

For the therapy of patients with solid tumors (ovary and breast), courses of TAXOL 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 and TAXOL 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 TAXOL therapy should have dosage reduced by 20% for subsequent courses of TAXOL. The incidence of neurotoxicity and the severity of neutropenia increase with dose.

Preparation and Administration Precautions: TAXOL is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised in handling TAXOL. The use of gloves is recommended. If TAXOL 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 TAXOL 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. (See PRECAUTIONS: Injection Site Reaction section.)

Preparation for Intravenous Administration: TAXOL must be diluted prior to infusion. TAXOL should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25°C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. 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.

Data collected for the presence of the extractable plasticizer DEHP [di-(2-ethylhexyl)phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended. TAXOL solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.

TAXOL should be administered through an in-line filter with a microporous membrane not greater than 0.22 microns. Use of filter devices such as IVEX2® filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DEHP.

The Chemo Dispensing PinÔ device or similar devices with spikes should not be used with vials of TAXOL since they can cause the stopper to collapse resulting in the loss of sterile integrity of the TAXOL solution.

Stability: Unopened vials of TAXOL Injection are stable until the date indicated on the package when stored between 20°- 25° C (68°-77° F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration components in the TAXOL vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25° C) and lighting conditions for up to 27 hours.

HOW SUPPLIED

NDC 0015-3475-30 30 mg/5 mL multidose vial individually packaged in a carton.
NDC 0015-3476-30 100 mg/16.7 mL multidose vial individually packaged in a carton.
NDC 0015-3479-11 300 mg/50 mL multidose vial individually packaged in a carton.


U.S. Patent Nos.: 5,496,804 and 5,641,803.

Storage: Store the vials in original cartons between 20° -25° C (68° -77° F). Retain in the original package to protect from light.

Handling and Disposal: Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1- 7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

REFERENCES

  1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.
  2. AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253 (11):1590-1592.
  3. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, SIDE Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts, 02115.
  4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426-428.
  5. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians 1983; (Sept/Oct) 258-263.
  6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm 1990; 47:1033-1049.
  7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm 1986; 43:1193-1204.

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