levoleucovorin

FDA Drug Profile — KHAPZORY

Drug Details

Generic Name
levoleucovorin
Brand Names
KHAPZORY
Application Number
NDA211226
Sponsor
Acrotech Biopharma Inc
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
LEVOLEUCOVORIN DISODIUM

Indications and 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 )