Vinblastine sulfate is available as a 1-mg/mL solution with benzyl alcohol 0.9% in 10-mL vials.2946 Each mL also contains sodium chloride 9 mg and water for injection.2946
pH
The pH of the vinblastine sulfate injection is 3.5 to 5.2946
Vinblastine sulfate is administered intravenously only.2946 It should not be given by any other route.2946 If the drug is prepared in a syringe, a sticker, which is provided in the vinblastine sulfate package, must be affixed directly to the syringe containing the individual dose stating:
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES.2946
In addition, the syringe containing the prepared dose must be enclosed in an overwrap, which is labeled:
DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION.
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES.2946
Vinblastine sulfate may be administered over about 1 minute either directly into a vein or into the tubing of a running infusion solution.2946 The dose of vinblastine sulfate should not be diluted in larger amounts of intravenous fluid (e.g., 100 to 250 mL) or administered over longer time periods (e.g., 30 to 60 minutes) since this frequently increases vein irritation and the chances of extravasation.2946 Extravasation should be avoided.2946
In the event of spills or leaks, sodium hypochlorite 5% (household bleach) has been used to inactivate vinblastine sulfate.1200
The vials should be refrigerated to ensure extended stability.2946 Room temperature stability of intact vials of a Lilly product was variously reported to be at least 1 month853 and only 14 days,1433 while a Lyphomed product was reported to be stable for up to 3 months1181 and for less than 2 months.1433
Vinblastine sulfate 0.015 and 0.5 mg/mL in sodium chloride 0.9% did not inhibit the growth of deliberately inoculated Staphylococcus epidermidis (106 to 107 CFU/mL) during 21 days at 35°C (representing near body temperature).1659
Immersion of a needle with an aluminum component in vinblastine sulfate 1 mg/mL resulted in no visually apparent reaction after 7 days at 24°C.988
pH Effects
Maximum stability for vinblastine sulfate in aqueous solutions was determined to be from pH 2 to 4. Vinblastine sulfate in solution at pH 3 retained 90% after 39 days at 20°C.1307
Vinblastine sulfate in solutions having a pH above 6 may form a precipitate of vinblastine base.1369
Freezing Solutions
Vinblastine sulfate (Lilly) 20 mcg/mL in dextrose 5%, Ringer’s injection, lactated, and sodium chloride 0.9% underwent no degradation after 4 weeks when frozen at -20°C.1195
Light Effects
It is recommended that vials be protected from light and stored in the outer carton until the time of use.2946
The effects of light exposure on a 1.197-mg/mL vinblastine sulfate solution in sterile water for injection were studied. Samples at 25°C were exposed to indirect incandescent (not fluorescent) light intermittently for 12 hours each day; another group was exposed to direct incandescent light intermittently for 12 hours daily with at least 2 additional hours of exposure to sunlight. A third group of samples at 30°C was exposed to continuous direct incandescent light. Both groups of samples exposed directly to light showed substantial losses of vinblastine sulfate. Samples exposed to continuous direct light sustained a 10% loss in about 1 day and a 71% loss in 14 days. Samples intermittently exposed to direct light and sunlight sustained a 10% loss in 8 days and a 23% loss in 15 days. However, samples exposed to intermittent indirect light showed no drug loss in 70 days.1306
Under 6% vinblastine loss occurred in 48 hours from a 3-mcg/mL solution in sodium chloride 0.9% contained as a static solution in polybutadiene tubing when exposed to normal mixed daylight and fluorescent light. It was concluded that photodegradation is not a problem with vinblastine sulfate under these conditions.1378
Syringes
Vinblastine sulfate (David Bull Laboratories) 1 mg/mL in polypropylene syringes was stable for 31 days at 8°C and for at least 23 days at 21°C in the dark; little or no loss occurred.1566
Vinblastine sulfate (Lilly) 1 mg/mL in sodium chloride 0.9% was packaged in polypropylene syringes (Plastipak, Becton Dickinson) and stored at 25°C protected from light. No vinblastine sulfate loss was found after storage for 30 days.2155
Elastomeric Reservoir Pumps
Vinblastine sulfate 0.2 mg/mL in both dextrose 5% and sodium chloride 0.9% was evaluated for binding potential to natural rubber elastomeric reservoirs (Baxter). Less than 1% binding was found after storage for 2 weeks at 35°C with gentle agitation.2014
Implantable Pumps
Vinblastine sulfate (Lilly) 1 mg/mL in bacteriostatic sodium chloride 0.9% was evaluated for stability in an implantable pump (Infusaid model 400). In this in vitro assessment, a 24% vinblastine loss occurred in 24 hours at 37°C with mild agitation. In 12 days, the loss totaled 48%. In comparison, control solutions in glass vials had no drug loss in 24 hours and a 20% loss in 12 days at 37°C. The authors believed that this indicated an interaction of vinblastine with some component of the Infusaid model 400, rendering it unsuitable for administration with this infusion device.767
Sorption
The stability of vinblastine sulfate (Lilly) 3 mcg/mL in methacrylate butadiene styrene (Avon A2001 Sureset) and cellulose propionate (Avon A200 standard and A2000 Amberset) when exposed to normal mixed daylight and fluorescent light for up to 48 hours was evaluated. A maximum vinblastine loss of about 5% resulted in the Sureset, with as little as a 2.25% loss occurring with foil wrapping. However, significant losses occurred in both cellulose propionate burettes in 24 hours, and losses of 15 to 20% occurred in 48 hours. The vinblastine sulfate solution in the polybutadiene tubing of the Sureset showed no more than a 6% drug loss with or without light protection. However, in the polyvinyl chloride (PVC) tubing of the standard or Amberset, losses were significant within 4 hours; at 48 hours, losses were 42 to 44%.1378
Vinblastine sulfate (Lilly) 10 mg/250 mL in dextrose 5% or sodium chloride 0.9%, in PVC bags at 22°C with protection from light, was infused over 2 hours at 2.08 mL/min through PVC sets. No loss due to sorption was found.1631
Vinblastine sulfate (Lederle) 250 mcg/mL in sodium chloride 0.9% exhibited no loss due to sorption to PVC and polyethylene administration lines during simulated infusions at 0.875 mL/hr for 2.5 hours via a syringe pump.1795
Filtration
Vinblastine sulfate (Lilly) 10 mg/50 mL in dextrose 5% and sodium chloride 0.9%, filtered at a rate of about 3 mL/min through a 0.22-µm cellulose ester membrane filter (Ivex-2), showed no significant reduction due to binding to the filter.533
Vinblastine sulfate 10 to 300 mcg/mL exhibited no loss due to sorption to either cellulose nitrate/cellulose acetate ester (Millex OR) or Teflon (Millex FG) filters.1415; 1416
Vinblastine sulfate (Lederle) 250 mcg/mL in sodium chloride 0.9% exhibited no loss due to sorption to cellulose acetate (Minisart 45, Sartorius) and polysulfone (Acrodisc 45, Gelman) filters. However, a 10 to 20% loss due to sorption occurred during the first 30 to 60 minutes of infusion through nylon filters (Nylaflo, Gelman, and Utipore, Pall). About a 30% loss was found during the first hour using a positively-charged nylon filter (Posidyne ELD96, Pall). The delivered concentrations gradually returned to the full concentrations within 2 to 2.5 hours.1795
Central Venous Catheter
Vinblastine sulfate (Lilly) 0.12 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
For a list of references cited in the text of this monograph, search the monograph titled References.