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Fusilev Generic Name & Formulations
Legal Class
Rx
General Description
Levoleucovorin (as calcium pentahydrate) 50mg/vial; pwd for IV inj after reconstitution; contains mannitol 50mg/vial; preservative-free.
Pharmacological Class
Folate analogue.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Fusilev Indications
Indications
Treatment of metastatic colorectal cancer in combination with 5-fluorouracil (5-FU).
Limitations of Use
Not for treating pernicious anemia and megaloblastic anemia secondary to the lack of Vit. B12; risk of neurologic manifestations despite hematologic remission.
Fusilev Dosage and Administration
Adult
Regimen 1: give levoleucovorin at 100mg/m2 by 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. The five-day treatment course may be repeated every 4 weeks for 2 courses, and then every 4–5 weeks provided that patient recovered from the toxicity from prior treatment course. Do not adjust levoleucovorin dosage for toxicity. Refer to 5-FU full labeling for dose modifications.
Children
Not established.
Fusilev Contraindications
Not Applicable
Fusilev Boxed Warnings
Not Applicable
Fusilev Warnings/Precautions
Warnings/Precautions
Hypercalcemia. Monitor for GI toxicities. Do not initiate or continue therapy if GI toxicities (eg, stomatitis, diarrhea) occur until symptoms resolved. Pregnancy. Nursing mothers.
Fusilev Pharmacokinetics
See Literature
Fusilev Interactions
Interactions
Potentiates 5-FU toxicity. Antagonizes TMP/SMZ. May antagonize anticonvulsants (eg, phenobarbital, primidone, phenytoin); monitor. May be affected by drugs that affect MTX elimination.
Fusilev Adverse Reactions
Adverse Reactions
Stomatitis, nausea, diarrhea.
Fusilev Clinical Trials
See Literature
Fusilev Note
Not Applicable
Fusilev Patient Counseling
See Literature
Fusilev Generic Name & Formulations
Legal Class
Rx
General Description
Levoleucovorin (as calcium pentahydrate) 50mg/vial; pwd for IV inj after reconstitution; contains mannitol 50mg/vial; preservative-free.
Pharmacological Class
Folate analogue.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Fusilev Indications
Indications
In osteosarcoma, for rescue after high-dose methotrexate (MTX) therapy. To diminish the toxicity associated with overdosage of folic acid antagonists or impaired MTX elimination.
Limitations of Use
Not for treating pernicious anemia and megaloblastic anemia secondary to the lack of Vit. B12; risk of neurologic manifestations despite hematologic remission.
Fusilev Dosage and Administration
Adults and Children
<6yrs: see full labeling. ≥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. MTX overdose or impaired elimination: Start as soon as possible or within 24hrs if impaired MTX excretion; give levoleucovorin 7.5mg every 6hrs until MTX <0.05micromolar. See full labeling.
Fusilev Contraindications
Not Applicable
Fusilev Boxed Warnings
Not Applicable
Fusilev Warnings/Precautions
Warnings/Precautions
Hypercalcemia. Monitor for GI toxicities. Do not initiate or continue therapy if GI toxicities (eg, stomatitis, diarrhea) occur until symptoms resolved. 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. Nursing mothers.
Fusilev Pharmacokinetics
See Literature
Fusilev Interactions
Interactions
Potentiates 5-FU toxicity. Antagonizes TMP/SMZ. May antagonize anticonvulsants (eg, phenobarbital, primidone, phenytoin); monitor. May be affected by drugs that affect MTX elimination.
Fusilev Adverse Reactions
Adverse Reactions
Stomatitis, vomiting, nausea.
Fusilev Clinical Trials
See Literature
Fusilev Note
Not Applicable
Fusilev Patient Counseling
See Literature
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