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VINCASAR PFS (vincristine sulfate injection) Injection is indicated in acute leukemia.
VINCASAR PFS (vincristine sulfate injection) Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin†s disease,3 non-Hodgkin†s malignant lymphomas 4-6 (lym-phocytic, mixed-cell, histiocytic, undifferentiated, nodular, and diffuse types), rhab-domyosarcoma,7 neuroblastoma,8 and Wilms† tumor.9
DOSAGE AND ADMINISTRATION
Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administering the dose of VINCASAR PFS (vincristine sulfate injection) Injection since overdosage may have a very serious or fatal outcome.
Special Dispensing Information: WHEN DISPENSING VINCRISTINE IN OTHER THAN THE ORIGINAL CONTAINER, IT IS IMPERATIVE THAT IT BE PACKAGED IN THE PROVIDED OVERWRAP WHICH BEARS THE FOLLOWING STATEMENT: "DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY." (see WARNINGS). A syringe containing a specific dose must be labeled, using the auxiliary sticker provided, to state: "FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY." The concentration of vincristine sulfate contained in all vials is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of VINCASAR PFS (vincristine sulfate injection) into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely.
Caution: It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of VINCASAR PFS (vincristine sulfate injection) may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage will help disperse the drug and may minimize discomfort and the possibility of cellulitis.
VINCASAR PFS (vincristine sulfate injection) must be administered via an intact, free-flowing intravenous needle or catheter. Care should be taken that there is no leakage or swelling occurring during administration (see boxed WARNINGS).
The solution may be injected either directly into a vein or into the tubing of a running intravenous infusion (see Drug Interactions below). Injection of VINCASAR PFS (vincristine sulfate injection) should be accomplished within 1 minute.
The drug is administered intravenously at weekly intervals.
The usual dose of VINCASAR PFS (vincristine sulfate injection) for children is 2 mg/m2. For children weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of VINCASAR PFS (vincristine sulfate injection) for adults is 1.4 mg/m2. A 50% reduction in the dose of VINCASAR PFS (vincristine sulfate injection) is recommended for patients having a direct serum bilirubin value above 3mg/dL.19
VINCASAR PFS (vincristine sulfate injection) should not be given to patients while they are receiving radiation therapy through ports that include the liver. When VINCASAR PFS (vincristine sulfate injection) is used in combination with L-asparaginase, VINCASAR PFS (vincristine sulfate injection) should be given 12 to 24 hours before administration of the enzyme in order to minimize toxicity; administering L-asparaginase before VINCASAR PFS (vincristine sulfate injection) may reduce hepatic clearance of VINCASAR PFS (vincristine sulfate injection) .
Drug Interactions VINCASAR PFS (vincristine sulfate injection) should not be diluted in solutions that raise or lower the pH outside the range of 3.5 to 5.5. It should not be mixed with anything other than 0.9% Sodium Chloride Injection or Dextrose Injection.
Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Handling and Disposal Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.20-26 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
VINCASAR PFS® Injection (vincristine sulfate injection, USP)
NDC 0013-7456-86 1 mg, 1 mg/1 mL (single dose), flip-top vial (mist gray cap) NDC 0013-7466-86 2 mg, 2 mg/2 mL (single dose), flip-top vial (blue cap)
This product should be refrigerated between 2° to 8°C (36° to 46°F). Discard unused solution.
2. Nelson RL: The comparative clinical pharmacology and pharmacokinetics of vinde-sine, vincristine, and vinblastine in human patients with cancer. Med Pediatr Oncol 1982; 10:115.
4. Bagley CM Jr, DeVita VT Jr, Berard CW, et al: Advanced lymphosarcoma: Intensive cyclical chemotherapy with cyclophosphamide, vincristine, and prednisone. Ann Intern Med 1972;76:227.
8. Sullivan MP, Nora AH, Kulapongs P, et al: Evaluation of vincristine sulfate and cyclo-phosphamide chemotherapy for metastatic neuroblastoma. Pediatrics 1969;44:685.
9. Vietti TJ, Sullivan MP, Haggard ME, et al; Vincristine sulfate and radiation therapy in metastatic Wilms† tumor. Cancer 1970;25:12.
10. International Agency for Research on Cancer. Monograph on the evaluation of the carcinogenic risk of chemicals to humans, suppl 4, October 1982.
11. Grossman SA, Sheidler VR, Gilbert MR: Decreased phenytoin levels in patients receiving chemotherapy. Am J Med 1989;87:505.
12. Roeser HP, Stocks AE, Smith AJ: Testicular damage due to cytotoxic drugs and recovery after cessation of therapy. Aust NZ J Med 1978;8:250.
13. Chapman R, Sutcliffe SB, Malpas JS: Male gonadal dysfunction in Hodgkin†s disease.
14. Sherins RJ, DeVita VT: Effect of drug treatment for lymphoma on male reproductive capacity. Ann Intern Med 1981;79:216.
15. DeVita VT: The consequences of the chemotherapy of Hodgkin†s disease. Cancer 1981;47:1.
16. Horning SJ, Hoppe RT, Kaplan HS, et al: Female reproductive potential after treatment for Hodgkin†s disease. N Engl J Med 1981;304:1377.
17. Blatt J, Poplack DG, Sherins RJ: Testicular function in boys after chemotherapy for acute lymphoblastic leukemia. N Engl J Med 1981;304:1121.
19. DeVita VT Jr, Hellman S, Rosenberg SA (eds): Cancer, Principles and Practice of Oncology, ed 2. Philadelphia. J.B. Lippincott Co., 1985.
20. 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.
21. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA. 1985; 253 (11): 1590-1592.
22. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D.,Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
23. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.
24. 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.
25. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033-1049.
26. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm. 1986; 43:1193-1204.
Manufactured for: Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA, Manufactured by: SP Pharmaceuticals, Albuquerque, NM 87109, USA, Revised August 2001. A-817 742 101This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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