levoleucovorin calcium

FDA Drug Profile — Levoleucovorin

Drug Details

Generic Name
levoleucovorin calcium
Brand Names
Levoleucovorin
Application Number
ANDA211003
Sponsor
Meitheal Pharmaceuticals Inc
NDC Codes
2
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
LEVOLEUCOVORIN CALCIUM

Indications and Usage

1 INDICATIONS AND USAGE Levoleucovorin for 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. Levoleucovorin for 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 for 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 ) Limitations of Use Levoleucovorin for 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.