Rx Item-Khapzory 175mg Levoleucovorin 1 By Ics Spectrum Pharma

for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Khapzory (levoleucovorin) is a folate analog indicated for:

rescue after high-dose methotrexate therapy in patients with osteosarcoma
diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
treatment of patients with metastatic colorectal cancer in combination with fluorouracil.


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.

Khapzory 175mg Levoleucovorin
Khapzory 175mg Levoleucovorin 1 By Ics Spectrum Pharma NDC 68152-0112-01 68152-112-01 B6815211201 68152011201 UPC 1-06815-211201-8 106815-2112018 1068152112018 MPN 11201

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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