Ben Venue Laboratories, Inc.                                                                      Bedford Laboratories™

Bedford, OH 44146                                                                                     Bedford, OH 44146

April 2005                                                                                                    MTX-LYO-P00
LEUCOVORIN RESCUE SCHEDULES FOLLOWING TREATMENT WITH HIGHER DOSES OF METHOTREXATE Clinical Situation Laboratory Findings Leucovorin Dosage and Duration
Normal Methotrexate Elimination Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours.
 15 mg PO, IM or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion).
Delayed Late Methotrexate Elimination Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration.
 Continue 15 mg PO, IM or IV q 6 hours, until methotrexate level is less than 0.05 micromolar.
Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration (e.g., an increase from 0.5 mg/dL
 150 mg IV q 3 hours, untilmethotrexate level is lessthan 1 micromolar; then15 mg IV q 3 hours, untilmethotrexate level is less than 0.05 micromolar.
VIAL LABELS
Vial Label 1 gram
Vial Label 50 mg in 2 mL
Vial Label 100 mg in 4 mL
Vial Label 200 mg in 8 mL
Vial Label 250 mg in 10 mL
CARTONS
Unit Carton 1 gram