GLUCARPIDASE Drug Interactions: What You Need to Know

INTERACTIONS

7.1 Effects of VORAXAZE on Leucovorin VORAXAZE can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended <span class="opacity-50 text-xs">[see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )]</span> . VORAXAZE may also reduce the concentrations other folate analogs or folate analog metabolic inhibitors.

7.2 Effect of VORAXAZE on Measurement of Methotrexate Concentration DAMPA (4-deoxy-4-amino-N10- methylpteroic acid), an inactive metabolite of methotrexate formed following VORAXAZE administration, interferes with the measurement of methotrexate concentration using immunoassays. This interference results in an overestimation of the methotrexate concentration. Based on the half-life of DAMPA, VORAXAZE may interfere with the measurement of methotrexate concentrations for approximately 48 hours following a VORAXAZE dose <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.2 )]</span> . When measuring methotrexate concentration following a VORAXAZE dose, a chromatographic method is preferred over an immunoassay.

None. None.

AND PRECAUTIONS Serious Hypersensitivity Reactions: Serious hypersensitivity reactions occurred. ( 5.1 )

Monitoring Methotrexate

Concentration: Measure methotrexate concentrations within 48 hours following VORAXAZE administration using a chromatographic method; immunoassays are unreliable for samples collected within 48 hours following VORAXAZE administration. ( 5.2 )

5.1 Serious Hypersensitivity Reactions Serious hypersensitivity reactions occurred in less than 1% of patients [ see Adverse Reactions ( 6.1 ) ].

5.2 Interference with Immunoassay Measurements of Methotrexate DAMPA (4-deoxy-4-amino-N 10 - methylpteroic acid), an inactive metabolite of methotrexate formed following VORAXAZE administration, interferes with the measurement of methotrexate concentration using immunoassays. This interference results in an overestimation of the methotrexate concentration. Based on the half-life of DAMPA (about 9 hours), VORAXAZE may interfere with the measurement of methotrexate concentration for up to 48 hours following a VORAXAZE dose <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.1 ) ]</span>. When measuring methotrexate concentration following a VORAXAZE dose, a chromatographic method is preferred over an immunoassay.