Vincristine sulfate is available as a 1-mg/mL preservative-free solution in single-use 1- and 2-mL vials.2947; 3727 Each mL of solution contains 1 mg of vincristine sulfate and mannitol 100 mg in water for injection.2947; 3727 Acetic acid and sodium acetate (Vincasar PFS, Teva) or sulfuric acid or sodium hydroxide (Hospira) may have been added to adjust pH during manufacturing.2947; 3727
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
pH
Vincristine sulfate has a pH ranging from 3.5 to 5.5 (Vincasar PFS, Teva)3727 or from 4 to 5 (Hospira).2947
Trade Name(s)
Vincasar PFS
CAUTION: Care should be taken to ensure that the correct drug product, dose, and administration procedures are used and that no confusion with other products occurs.
Vincristine sulfate is administered intravenously only.2947; 3727 It should not be given by any other route.2947; 3727 To reduce the risk of fatal medication errors due to the incorrect route of administration, vincristine sulfate should be diluted with a suitable infusion solution in a flexible plastic container and prominently labeled:
FOR INTRAVENOUS USE ONLY - FATAL IF GIVEN BY OTHER ROUTES.2947; 3727
Preparation of vincristine sulfate in a syringe for administration is not recommended because of the potential for inadvertent intrathecal administration of the drug.3728; 3729
The diluted vincristine sulfate injection may be infused directly into a free-flowing intravenous needle or catheter or into a running intravenous infusion.2947; 3727 It also has been diluted and administered as an intermittent or continuous intravenous infusion.4 Extravasation can result in considerable irritation and should be avoided.2947; 3727
In the event of spills or leaks, sodium hypochlorite 5% (household bleach) has been used to inactivate vincristine sulfate.1200
Intact vials of vincristine sulfate should be stored under refrigeration, kept upright, and protected from light.2947; 3727 Unused drug solution should be discarded.2947; 3727 The pH range of maximum stability is 4 to 6.1195 Precipitation may occur at alkaline pH values.1369 Vincristine sulfate should not be added to solutions that would raise or lower the pH outside the 3.5 to 5.5 range.2947 Only dextrose or sodium chloride 0.9% are recommended.2947
Admixtures containing doxorubicin hydrochloride, etoposide phosphate, and vincristine sulfate in a variety of concentration combinations in sodium chloride 0.9% were unable to pass the USP test for antimicrobial growth effectiveness. Mixtures of these drugs are not “self-preserving” and will permit microbial growth.2343
Immersion of a needle with an aluminum component in vincristine sulfate 1 mg/mL resulted in no visually apparent reaction after 7 days at 24°C.988
Freezing Solutions
Vincristine 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
Syringes
Vincristine sulfate (Lilly) 0.5, 1, 2, and 3 mg diluted to 20 mL with sodium chloride 0.9% and packaged in 30-mL polypropylene syringes (Becton Dickinson) was stored for 7 days at 4°C followed by 2 days at 23°C. All samples remained physically compatible with no increase in measured turbidity or particle content. No loss occurred after 7 days at 4°C and not more than 5% loss after 2 additional days at room temperature.2350
Sorption
Vincristine sulfate 2 mg/250 mL in dextrose 5% or sodium chloride 0.9% in polyvinyl chloride (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
Vincristine sulfate 25 mcg/mL in sodium chloride 0.9% exhibited no loss due to sorption to a polyethylene administration line (Vygon) during simulated infusions at 0.875 mL/hr for 2.5 hours via a syringe pump. However, about a 9% loss of delivered concentration due to sorption occurred during the first hour using a PVC administration line (Baxter). The delivered concentration returned to the full concentration within 1.5 hours.1795
Filtration
Vincristine sulfate (Lilly) 1 mg/50 mL in dextrose 5% and sodium chloride 0.9% was filtered at about 3 mL/min through a 0.22-µm cellulose ester membrane filter (Ivex-2). Losses of vincristine sulfate due to binding to the filters were noted in both solutions. In dextrose 5%, about 6.5% of the vincristine sulfate was bound; about 12% of the drug was lost from the sodium chloride 0.9% solution.533
In static equilibrium experiments, 100 mg of 0.22-µm cellulose ester membrane filter (Ivex-2) was soaked in 25 mL of vincristine sulfate (Lilly) 10 and 20 mcg/mL in both dextrose 5% and sodium chloride 0.9%. The higher concentration exhibited about 20 to 30% binding to the filter in 24 to 48 hours. The lower concentration had about 30 to 45% binding in the same period.533
A filter material specially treated with a proprietary agent was evaluated for a reduction in vincristine sulfate binding. Vincristine sulfate (Lilly) 1 mg/50 mL in dextrose 5% and sodium chloride 0.9% was run through an administration set with a treated 0.22-µm cellulose ester inline filter at a rate of 3 mL/min. Cumulative vincristine sulfate losses of about 1% occurred from both solutions compared to the much higher losses previously reported for untreated cellulose ester filter material. Furthermore, equilibrium binding studies showed 5- and 7-fold reductions in binding from dextrose 5% and sodium chloride 0.9%, respectively.904 All Abbott Ivex integral filter and extension sets use this treated filter material.1074
Vincristine sulfate 1.5 mg/3 mL was injected through a 0.2-µm nylon, air-eliminating, filter (Ultipor, Pall) to evaluate the effect of filtration on simulated intravenous push delivery. About 90% of the drug was delivered through the filter after flushing with 10 mL of sodium chloride 0.9%.809
Vincristine sulfate 10 to 200 mcg/mL exhibited a 10 to 15% loss due to sorption to both cellulose nitrate/cellulose acetate ester (Millex OR) and Teflon (Millex FG) filters.1415; 1416
Vincristine sulfate (David Bull Laboratories) 250 mcg/mL in sodium chloride 0.9% exhibited little loss due to sorption to cellulose acetate (Minisart 45, Sartorius) and polysulfone (Acrodisc 45, Gelman) filters. However, a 5 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 20 to 25% loss was found during the first hour using a nylon filter (Posidyne ELD96, Pall). The delivered concentrations gradually returned to the full concentrations within 2 to 2.5 hours.1795
Central Venous Catheter
Vincristine sulfate (Lilly) 0.05 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.