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Vincristine Sulfate Injection

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Vincristine Sulfate Injection

Indications
Dosage
How Supplied

INDICATIONS

Vincristine sulfate injection (vincristine sulfate) is indicated in acute leukemia.

Vincristine sulfate injection (vincristine sulfate) has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non-Hodgkin's malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.

DOSAGE AND ADMINISTRATION

This preparation is for intravenous use only (see WARNINGS).

Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administering the dose of Vincristine Sulfate Injection, USP (vincristine sulfate) since overdosage may have a very serious or fatal outcome.

Special Dispensing Information: WHEN DISPENSING VINCRISTINE SULFATE INJECTION (vincristine sulfate) , USP 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 Injection, USP (vincristine sulfate) is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of Vincristine Sulfate Injection, USP (vincristine sulfate) 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 Vincristine Sulfate Injection, USP (vincristine sulfate) 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.

Vincristine Sulfate Injection, USP (vincristine sulfate) 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 Vincristine Sulfate Injection, USP (vincristine sulfate) should be accomplished within 1 minute.

The drug is administered intravenously at weekly intervals.

The usual dose of Vincristine Sulfate Injection, USP (vincristine sulfate) for pediatric patients is 1.5-2 mg/m². For pediatric patients weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of Vincristine Sulfate Injection, USP for adults is 1.4 mg/m². A 50% reduction in the dose of Vincristine Sulfate Injection, USP (vincristine sulfate) is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL.

Vincristine Sulfate Injection, USP (vincristine sulfate) should not be given to patients while they are receiving radiation therapy through ports that include the liver. When Vincristine Sulfate Injection (vincristine sulfate) , USP is used in combination with L-asparaginase, Vincristine Sulfate Injection, USP (vincristine sulfate) should be given 12 to 24 hours before administration of the enzyme in order to minimize toxicity; administering L-asparaginase before Vincristine Sulfate Injection, USP (vincristine sulfate) may reduce hepatic clearance of vincristine.

Drug Interactions - Vincristine Sulfate Injection, USP (vincristine sulfate) 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 normal saline or glucose in water.

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. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

Vincristine Sulfate Injection, USP (vincristine sulfate) , preservative free solution.

NDC 61703-309-06 1 mg, 1 mg/1 mL (single use), flip-top vial (blue cap)
NDC 61703-309-16 2 mg, 2 mg/2 mL (single use), flip-top vial (blue cap)

This product should be refrigerated between 2°-8°C (36°-46°F). Discard unused solution. Protect from light.

Store Upright.

REFERENCES

1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 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, ScD., 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: Report from the Mount Sinai Medical Center. CA - A Cancer Journal of 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.

Hospira, Inc., Lake Forest, IL 60045. Product of Australia. Revision December 2007. FDA rev date: 10/28/2003

Last reviewed on RxList: 9/16/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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