Monograph Details
|
|
Neoplasms
> Cytoprotective agents
|
|
FUSILEV |
| Manufacturer |
|
Spectrum Pharmaceuticals, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Folate analogue. |
| Generic Name |
|
Levoleucovorin (as calcium pentahydrate) 50mg/vial; pwd for IV inj after reconstitution; contains mannitol 50mg/vial. |
| Indications |
|
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 |
|
<6years: see literature. ≥6years: 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. |
| 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. |
| Adverse Reactions |
|
Stomatitis, vomiting, nausea. |
| How Supplied |
|
Single-use vial—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
