RX ITEM-Levoleucovorin 1 By Ics Spectrum Pharma Direct Ds

LEVOLEUCOVORIN CALCIUM- levoleucovorin calcium injection, solution
Mylan Institutional LLC

1 INDICATIONS AND USAGE

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Levoleucovorin injection is a folate analog.
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Levoleucovorin injection rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
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Levoleucovorin injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
1.1 Limitations of Use


Levoleucovorin injection is not approved for pernicious anemia and megaloblastic anemias secondary to the lack of vitamin B12 . Improper use may cause a hematologic remission while neurologic manifestations continue to progress.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Guidelines
Levoleucovorin injection is dosed at one-half the usual dose of racemic d,l -leucovorin.
Levoleucovorin Injection Rescue After High-Dose Methotrexate Therapy
The recommendations for levoleucovorin injection rescue are based on a methotrexate dose of 12 grams/m2 administered by intravenous infusion over 4 hours (see methotrexate package insert for full prescribing information). Levoleucovorin injection rescue at a dose of 7.5 mg (approximately 5 mg/m2) every 6 hours for 10 doses starts 24 hours after the beginning of the methotrexate infusion.

Serum creatinine and methotrexate levels should be determined at least once daily. Levoleucovorin injection administration, hydration, and urinary alkalinization (pH of 7.0 or greater) should be continued until the methotrexate level is below 5 x 10-8 M (0.05 micromolar).
Levoleucovorin injection is indicated for intravenous administration only. Do not administer intrathecally. DOSAGE FORMS AND STRENGTHS

Levoleucovorin Injection, 175 mg is supplied in a single-use vial containing 17.5 mL sterile solution. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride.

Levoleucovorin Injection, 250 mg is supplied in a single-use vial containing 25 mL sterile solution. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride.

RX ITEM-Levoleucovorin 1 By Ics Spectrum
NDC 01106-0188-00 UPC/GTIN No.3-11060-18800-4 Mfg.Part No.18700

Levoleucovorin 1 By Ics Spectrum Pharma
BRAND: LEVOLEUCOVORIN NDC: 01106-0188-00,1106018800 UPC: 3-11060-18800-4,311060188004 Ics/Spectrum Pharma Direct Ds

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