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Information

AHFS Class:

10:00 Antineoplastic Agents


Generic Name

Products

Vinorelbine tartrate is available as a preservative-free 10-mg/mL concentrate for injection in 1- and 5-mL single-dose vials containing 10 and 50 mg, respectively, of vinorelbine.1183 Each mL of solution contains vinorelbine tartrate equivalent to vinorelbine 10 mg in water for injection.1183 The concentrate for injection must be diluted in a compatible infusion solution to a concentration between 0.5 to 2 mg/mL prior to administration.1183

Equivalency

Vinorelbine tartrate 13.85 mg is equivalent to 10 mg of vinorelbine.1183

pH

The injection concentrate has a pH of approximately 3.5.1183

Administration

Vinorelbine tartrate is administered intravenously following dilution in a compatible infusion solution in an infusion bag.1183 The diluted solution is recommended to be administered over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of a compatible infusion solution.1183 Extravasation should be avoided due to tissue injury, necrosis, and thrombophlebitis.1183 A literature review for the period 1966 through 2004 did not find a statistically significant difference in the rate of venous irritation from 1- to 2-minute intravenous pushes and 6- to 10-minute intravenous infusions.2637

Intrathecal injection of vinca alkaloids has resulted in death.3728 Preparation of vinca alkaloids, including vinorelbine tartrate, in a syringe for administration is not recommended because of the potential for inadvertent intrathecal administration of the drug.3728

Stability

Vinorelbine tartrate injection concentrate is a clear, colorless to pale yellow solution.1183 Intact vials should be refrigerated at 2 to 8°C and protected from light (by storage in the carton) and freezing.1183 Intact vials are stable at 25°C for up to 72 hours.1183

Diluted solutions for infusion prepared in PVC bags and stored at 5 to 30°C under normal room light may be used for up to 24 hours.1183

Vinorelbine tartrate 0.1 mg/mL diluted in sodium chloride 0.9% and stored at 22°C did not exhibit an antimicrobial effect on the growth of 4 organisms (Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) inoculated into the solution. The author recommended that diluted solutions of vinorelbine tartrate be stored under refrigeration whenever possible and that the potential for microbiological growth be considered when assigning expiration periods.2160

Sorption

Vinorelbine tartrate was shown not to exhibit sorption to PVC bags and tubing as well as polyethylene and glass containers.1631; 2420; 2430

Compatibility

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Other Info

References

For a list of references cited in the text of this monograph, search the monograph titled References.

Copyrights

ASHP® Injectable Drug InformationTM. Selected Revisions December 5, 2024. © Copyright, 2024. American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.