FUSILEV Rx

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FUSILEV

Colorectal and other GI cancers
Cytoprotective and supportive care agents
Only 4 drugs may be compared at once

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.

Select therapeutic use:

Indications for FUSILEV:

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

Adult:

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:

Not recommended.

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.

Pharmacological Class:

Folate analogue.

Adverse Reactions:

Stomatitis, nausea, diarrhea.

Generic Availability:

NO

How Supplied:

Single-use vial (pwd, soln)—1

FUSILEV 5ml of 50mg vials (Qty:1)

appx. price $1249.00

Indications for FUSILEV:

In osteosarcoma, to reduce toxicity of high-dose methotrexate (MTX) therapy. To reduce toxicity and counteract effects of impaired MTX elimination and of inadvertent overdose of folic acid antagonists.

Adults and Children:

<6yrs: see literature. ≥6yrs: Give by IV inj; max rate 160mg/min. High-dose MTX rescue: Start 24hrs after the beginning of MTX infusion (based on MTX dose of 12g/m2 over 4hrs). Normal MTX elimination: give levoleucovorin 7.5mg (approximately 5mg/m2) every 6hrs for 10 doses. Delayed late MTX elimination: continue levoleucovorin 7.5mg every 6hrs until MTX <0.05micromolar; delayed early MTX elimination and/or evidence of acute renal injury: levoleucovorin 75mg every 3hrs until MTX <1micromolar, then 7.5mg every 3hrs until MTX <0.05micromolar. May continue another 24hrs for subsequent courses in cases of significant clinical toxicity. Inadvertent MTX overdose: Start as soon as possible or within 24hrs if delayed MTX excretion. Levoleucovorin 7.5mg every 6hrs until MTX <0.05micromolar. See literature.

Warnings/Precautions:

Not for treating pernicious anemia and megaloblastic anemia. Monitor serum creatinine and MTX levels every 24hrs. Delayed early MTX elimination may cause reversible renal failure; provide hydration, alkalinize urine with sodium bicarbonate, closely monitor fluid and electrolytes until serum MTX <0.05 micromolar and renal failure resolves. 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.

Pharmacological Class:

Folate analogue.

Adverse Reactions:

Stomatitis, vomiting, nausea.

Generic Availability:

NO

How Supplied:

Single-use vial (pwd, soln)—1

FUSILEV 5ml of 50mg vials (Qty:1)

appx. price $1249.00