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This study was designed to simulate concurrent infusion of separate solutions of IR and LV using a Y-site connection and to evaluate the stability of these compounds under such conditions. Six treatment scenarios were designed, including those most frequently used in practice, as well as those representing potential extremes of practice (Table 1). In each scenario, IR at a concentration of 0.61 mg/mL was mixed with LV at concentrations of 1.36 mg/mL, 2.72 mg/mL, or 7.20 mg/mL. A concentration between 0.61 and 0. 65 mg/mL of IR would be used for an average person (1.7 m2 to 1.8 m2 body surface area) receiving a dose of IR of 180 mg/m2 diluted in D5W (concentrations of 300 to 324 mg/500 mL). Similarly, the concentrations of LV (1.36, 2.72, and 7.20 mg/mL) would be used for an average person (1.7 m2 to 1.8 m2) receiving a dose of LV of either 200 or 400 mg/m2 diluted in 100-mL or 250-mL bags of D5W.

The final concentration of both drugs in a Y-site line after mixing depends not only on the concentration of the drugs in solution but also the flow rates of each solution. A more complete disclosure of volumes and rates used in the estimates of the final concentrations can be found in Table 1. These concentrations do not consider bag-overfill volumes or the volume of the drug solution added to the bag and so are slightly higher than might actually be encountered in practice under similar scenarios.
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Table 1. Irinotecan-Leucovorin Treatment Scenarios and Calculation of Final Concentrations


Key Scenario Characteristic


Scenario


Drug


Dose


Average


Diluent


Concentration*


Infusion


Projected


Designation


(mg/m2)


Body


Volume


(mg/mL)


Duration


Mixed Final


Size (m2)


(mL)


(min)


Concentrationt


(mg/mL)


Standard infusion times


1a


IR


180


1.8


500


0.65


90


0.56


for
both irinotecan


(90


min)


LV


400


1.8


100


7.20


120


0.94


and
leucovorin


(120


min)


1b


IR


180


1.7


500


0.61


90


0.53


LV


400


1.7


250


2.72


120


0.74


Leucovorin infusion twice


2a


IR


180


1.8


500


0.65


60


0.59


as long as irinotecan infusion


LV


400


1.8


100


7.20


120


0.66


2b


IR


180


1.7


500


0.61


60


0.56


LV


200


1.7


250


1.36


120


0.27


Equal flow rates


3a


IR


180


1.8


500


0.65


300


0.32


LV


400


1.8


100


7.20


60


3.60


3b


IR


180


1.7


500


0.61


120


0.30


LV


200


1.7


250


1.36


60


0.68

Each treatment scenario was implemented by combining IR hydrochloride trihydrate (Camptosar, 20 mg/mL, Pharmacia & UpJohn, Mississauga, Ontario; lot 18JAK, expiry June 2005) and LV calcium for injection USP (10 mg/mL, Novopharm, Toronto, Ontario; lot 027120201, expiry December 2004), each diluted in D5W. Each of the 6 treatment scenarios was evaluated in each of 3 different container types, to simulate different types of infusion tubing: glass test tubes (containing D5W from a PVC bag, Baxter Corporation, lot W2L12A1, expiry June 2004), which served as control; PVC bags (Baxter Corporation, lot W2L12A1, expiry June 2004); and polypropylene-polyethylene copolymer bags (partial additive bags [PAB®]; B. Braun Medical Inc, Irvine, California, lot J2D954, expiry July 2003). Thus, 18 separate experiments were designed, and each experiment was conducted in triplicate (n = 54 experimental solutions). All experiments were conducted at room temperature (23°C) under ambient fluorescent room lighting without protection from light.
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The concentration of IR and LV in each solution was determined by HPLC at time 0 (immediately after mixing) and at 0.5 h, 1 h, and 24 h.