Leucovorin Calcium — 5MG, Tablet, bottle of 30 tablets

Leucovorin Calcium — 5MG, Tablet, bottle of 30 tablets

Leucovorin Calcium is a tablet for oral use. Leucovorin is a folate analog indicated: • To reduce the toxicity of: o Methotrexate in adult patients with impaired methotrexate elimination, and o Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. ( 1.1 ) • For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). ( 1.2 ) Limitations of Use Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. ( 1.2 ) Limitations of Use Leucovorin is not indicated for the treatment of pernicious anemia or other megaloblastic anemias, due to the lack of vitamin B12, because of the risk of progression of neurologic manifestations despite

• Active ingredient or product type: LEUCOVORIN CALCIUM
• Strength/concentration: 5MG
• Dosage form and route: Tablet, Oral
• Exact package presentation: bottle of 30 tablets
• NDC/item number: 0054-4496-13
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.
• Status: Rx only

Important safety information: Hypersensitivity Reactions : Withhold or permanently discontinue leucovorin based on severity and indication. ( 4 , 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylactic reactions and urticaria, have been reported following the administration of leucovorin.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.