Vincristine Sulfate Recall
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FDA Safety Alerts
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FDA Labeling Changes
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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.
There is currently no drug history available for this drug.
Vincristine Sulfate Injection, USP is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn). Originally known as leurocristine, it has also been referred to as LCR and VCR.
The molecular formula for Vincristine Sulfate, USP is C46H56N4O10•H2SO4. It has a molecular weight of 923.04.
The structural formula is as follows:
Vincristine Sulfate, USP is a white to off–white powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, Vincristine Sulfate, USP has an ultraviolet spectrum with maxima at 221 nm (∈+47,100).
Vincristine Sulfate Injection, USP is a sterile, preservative–free, single use only solution available for intravenous use in 2 mL (1 mg and 2 mg) vials. Each mL contains 1 mg Vincristine Sulfate, USP, 100 mg mannitol and Water for Injection, USP. Q.S. Sulfuric acid or sodium hydroxide have been added for pH control. The pH of Vincristine Sulfate Injection, USP ranges from 4.0 to 5.0. At the time of manufacture, the air in the containers is replaced by nitrogen.