Generic Name and Formulations:
Levoleucovorin (as calcium pentahydrate) 50mg/vial; pwd for IV inj after reconstitution; contains mannitol 50mg/vial; 175mg/17.5mL; soln for IV inj; preservative-free.

Company:
Spectrum Pharmaceuticals, Inc.

Indications for FUSILEV:
Palliative treatment of advanced metastatic colorectal cancer in combination with 5-fluorouracil (5-FU).

Adult Dose for FUSILEV:
Administer levoleucovorin and 5-FU separately to avoid precipitate formation. Regimen 1: give levoleucovorin at 100mg/m2 by slow IV inj over a minimum of 3 minutes, followed by 5-FU at 370mg/m2 by IV inj. Regimen 2: give levoleucovorin at 10mg/m2 by IV inj, followed by 5-FU at 425mg/m2 by IV inj. Both: Treat daily for 5 days. Five-day treatment course may be repeated at 4 week (28 days) intervals for 2 courses, and then repeated at 4–5 week (28–35 days) intervals provided that patient recovered completely from toxic effects from prior treatment course. Dose adjustments for subsequent treatment course: see literature.

Children's Dose for FUSILEV:
Not recommended.

Pharmacological Class:
Folate analogue.

Warnings/Precautions:
Not for treating pernicious anemia and megaloblastic anemia. Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers.

Interactions:
Potentiates 5-fluorouracil toxicity. Antagonizes TMP/SMZ. Antagonizes anticonvulsants (eg, phenobarbital, primidone, phenytoin). May be affected by drugs that affect MTX elimination.

Adverse Reactions:
Stomatitis, nausea, diarrhea.

Generic Availability:
NO

How Supplied:
Single-use vial (pwd, soln)—1