VYKOURA

Leucovorin pharmacokinetics were observed after a single intramuscular dose of 10 mg/m 2 in healthy subjects and are presented as mean (CV%) unless otherwise specified. Leucovorin baseline-corrected maximum plasma concentration (Cmax) is 1,832 ng/mL (14%) and the total systemic exposure (AUC) is 23,043 ng*hr/mL (15%).

AbsorptionLeucovorin median (min, max) time to maximum plasma concentration (Tmax) is 1.7 hours (0.7, 4.5).

EliminationLeucovorin estimated terminal half-life is approximately 9....

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hypercalcemia [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with leucovorin rescue are stomatitis and vomiting. ( 6.1 ) The most common adverse reactions (>50%) in patients receiving leucovorin in combination with fluorouracil for metastatic colorectal cancer are...

VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid [see Warnings and Precautions (5.1) ]. Reactions have included anaphylactic reactions. VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid. ( 4 )

Hypersensitivity : Hypersensitivity reactions, including anaphylactic reactions and urticaria can occur. Withhold or permanently discontinue VYKOURA based on the severity of hypersensitivity. ( 5.1 ) Hypercalcemia : Due to calcium content, inject no more than 16 mL (160 mg) of VYKOURA intravenously per minute. ( 5.2 ) Risk of Administration Errors : Do not administer VYKOURA intrathecally. ( 5.3 ) 5.1 Hypersensitivity Hypersensitivity reactions, including anaphylactic reactions and urticaria, ha...

7 DRUG INTERACTIONS 7.1 Effects of Other Drugs on VYKOURA Glucarpidase Administer VYKOURA at least 2 hours before or 2 hours after the glucarpidase dose when administering concomitantly. Glucarpidase can decrease leucovorin concentrations, which may decrease the effect of leucovorin rescue. 7.2 Effects of VYKOURA on Other Drugs Certain Antiepileptic Drugs Increase monitoring for seizure activity i...