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Vincristine (Vincristine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Vincristine sulfate injection is indicated in acute leukemia.

Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non–Hodgkin’s malignant lymphomas, 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 since overdosage may have a very serious or fatal outcome.

The usual dose of Vincristine Sulfate Injection, USP 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 is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL.

The drug is administered intravenously at weekly intervals.

TO REDUCE THE POTENTIAL FOR FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION, VINCRISTINE SULFATE INJECTION SHOULD BE DILUTED IN A FLEXIBLE PLASTIC CONTAINER AND PROMINENTLY LABELED FOR INTRAVENOUS USE ONLY (See WARNINGS).

The concentration of Vincristine Sulfate Injection, USP 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 into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely.

Preparation for flexible plastic container

Vincristine Sulfate Injection, USP when diluted with 0.9% Sodium Chloride Injection in concentrations from 0.0015 mg/mL to 0.08 mg/mL is stable for up to 24 hours when protected from light or 8 hours under normal light at 25°C.

Preparation for syringe

Special Dispensing Information: when dispensing Vincristine Sulfate Injection, USP in a syringe, it is imperative that it be packaged in the provided overwrap which bears the following statement: “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES” (see WARNINGS ). A syringe containing a specific dose must be labeled, using the auxiliary sticker provided, to state: “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN  BY OTHER ROUTES.”

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 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 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 should be accomplished within 1 minute.

Patients Receiving Radiation Therapy - Vincristine Sulfate Injection, USP should not be given to patients while they are receiving radiation therapy through ports that include the liver. When Vincristine Sulfate Injection, USP is used in combination with L–asparaginase, Vincristine Sulfate Injection, USP 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 may reduce hepatic clearance of vincristine.

Drug Interactions – Vincristine Sulfate Injection, USP 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  There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

Vincristine Sulfate Injection, USP, 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.

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