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🏅 FDA Orphan Designation

Fusilev

levoleucovorin

Manufacturer: Acrotech Biopharma LLC

Indicated for:
OsteosarcomaMethotrexate toxicityHereditary nonpolyposis colon cancer

FDA-Approved Indications (3)

rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma

Population: adult and pediatric patients

diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients

Population: adult and pediatric patients

treatment of adults with metastatic colorectal cancer in combination with fluorouracil

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE Levoleucovorin Injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin Injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin Injection is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. ( 1 ) Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ( 1 ) Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. ( 1 ) Limitations of Use Levoleucovorin Injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. ( 1 )

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.