f 0.1 mg/mL, 0.2 mg/mL, or 0.4 mg/mL arestable at room temperature for up to 24 hours after preparation. VUMON solutionsprepared at a final teniposide concentration of 1.0 mg/mL should be administeredwithin 4 hours of preparation to reduce the potential for precipitation. Refrigerationof VUMON solutions is not recommended. Stability and use times areidentical in glass and plastic parenteral solution containers.
Althoughsolutions are chemically stable under the conditions indicated, precipitationof teniposide may occur at the recommended concentrations, especially if thediluted solution is subjected to more agitation than is recommended to preparethe drug solution for parenteral administration. In addition, storage timeprior to administration should be minimized and care should be taken to avoidcontact of the diluted solution with other drugs or fluids. Parenteral drugproducts should be inspected visually for particulate matter and discolorationprior to administration whenever solution and container permit. Precipitationhas been reported during 24-hour infusions of VUMON diluted to teniposideconcentrations of 0.1 to 0.2 mg/mL, resulting in occlusionof central venous access catheters in several patients. Heparin solution cancause precipitation of teniposide, therefore, the administration apparatusshould be flushed thoroughly with 5% Dextrose Injection, USP or 0.9% SodiumChloride Injection, USP before and after administration of VUMON.
Hypotensionhas been reported following rapid intravenous administration; it is recommendedthat the VUMON solution be administered over at least a 30- to 60-minute period. VUMONshould not be given by rapid intravenous injection.
Ina 24-hour study under simulated conditions of actual use of the product relativeto dilution strength, diluent and administration rates, dilutions at 0.1 to1.0 mg/mL were chemically stable for at least 24 hours. Data collected forthe presence of the extractable DEHP [di(2-ethylhexyl) phthalate] from PVCcontainers show that levels increased with time and concentration of the solutions.The data appeared similar for 0.9% Sodium Chloride Injection, USP, and 5%Dextrose Injection, USP. Consequently, the use of PVC containers is not recommended.
Similarly,the use of non-DEHP intravenous administration sets is recommended. Lipidadministration sets or low DEHP-containing nitroglycerin sets will keep patient’sexposure to DEHP at low levels and are suitable for use. The diluted solutionsare chemically and physically compatible with the recommended intravenousadministration sets and LVP containers for up to 24 hours at ambient roomtemperature and lighting conditions. Because of the potential for precipitation,compatibility with other drugs, infusion materials, or intravenous pumps cannotbe assured.
Unopenedampules of VUMON are stable until the date indicated on the package when storedunder refrigeration (2°-8°C) in the original package. Freezing does not adverselyaffect the product.
VUMON (teniposideinjection)
NDC 0015-3075-19 50 mg/5 mL sterile, clear, colorless glass ampules individuallypackaged in a carton.
Storethe unopened ampules under refrigeration (2°-8°C). Retain in original packageto protect from light.
VePesid is the registered trademark of Bristol-Myers Squibb Company.
Manufactured for:Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USAMade in Italy
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