Levoleucovorin calcium is available as a lyophilized powder in preservative-free single-dose vials containing the equivalent of 50 mg of levoleucovorin.3196 Each vial also contains mannitol 50 mg and sodium hydroxide and/or hydrochloric acid for pH adjustment.3196 The drug should be reconstituted with 5.3 mL of sodium chloride 0.9% to yield a levoleucovorin concentration of 10 mg/mL.3196 The manufacturer states that reconstitution with sodium chloride solutions containing a preservative (e.g., benzyl alcohol) has not been studied.3196 The reconstituted solution may be immediately diluted in sodium chloride 0.9% or dextrose 5% to a final levoleucovorin concentration of 0.5 to 5 mg/mL.3196
Levoleucovorin calcium also is available as a 10-mg/mL injection solution in 17.5- or 25-mL preservative-free single-dose vials containing 175 or 250 mg, respectively, of levoleucovorin as the calcium salt in sodium chloride 0.83%..3197 Each vial also contains sodium hydroxide for pH adjustment.3197 Levoleucovorin calcium injection solution may be further diluted with sodium chloride 0.9% or dextrose 5% to a final levoleucovorin concentration of 0.5 mg/mL.3197
Equivalency
Levoleucovorin calcium pentahydrate 64 mg is equivalent to levoleucovorin 50 mg.3196
pH
Levoleucovorin calcium injection solution has a pH ranging from 6.5 to 8.5.3197
Trade Name(s)
Fusilev
Levoleucovorin calcium is administered intravenously by infusion or injection.3196; 3197 For certain indications, the manufacturer states that the drug should be administered by slow intravenous injection over at least 3 minutes.3196; 3197 Levoleucovorin calcium should not be administered at a rate faster than 160 mg/min due to the calcium content.3196; 3197
Levoleucovorin calcium should not be administered intrathecally.3196; 3197
Fluorouracil and levoleucovorin calcium should be administered separately to avoid formation of a precipitate.3196; 3197
Intact vials of levoleucovorin calcium lyophilized powder should be stored at controlled room temperature, protected from light, in the original carton until time of use.3196 Intact vials of levoleucovorin calcium injection solution should be stored at 2 to 8°C, protected from light, in the original carton until time of use.3197
Reconstituted solutions and reconstituted solutions diluted in sodium chloride 0.9% may be stored for no more than 12 hours at room temperature.3196 Reconstituted solutions diluted in dextrose 5% may be stored for no more than 4 hours at room temperature.3196
Diluted solutions prepared from levoleucovorin calcium injection solution in sodium chloride 0.9% or dextrose 5% may be stored at room temperature for no more than 4 hours.3197
Reconstituted and/or diluted solutions of levoleucovorin calcium should be visually inspected for particulate matter and discoloration prior to administration; if cloudiness or precipitate is observed, solutions should not be used.3196; 3197
Levoleucovorin calcium should not be mixed with other drugs in the same container because of the risk of precipitation.3196; 3197
Freezing Solutions
Levoleucovorin calcium injection solution (Wyeth) diluted to a levoleucovorin concentration of 1.6 mg/mL in dextrose 5% in polyolefin bags (Baxter) was stored frozen at -20°C for 95 days.3227 The solution was then microwave thawed and stored refrigerated at 2 to 8°C for 30 days.3227 The solution was physically stable and no loss of drug occurred during the study.3227
Syringes
Levoleucovorin lyophilized powder (Teva) reconstituted with water for injection to a levoleucovorin concentration of 10 mg/mL and stored in polypropylene syringes was physically and chemically stable with no loss in 14 days when stored at 2 to 8°C protected from light.3228
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Fluorouracil
Manufacturers state fluorouracil and levoleucovorin calcium should be administered separately to avoid formation of a precipitate.3196; 3197
For a list of references cited in the text of this monograph, search the monograph titled References.