Glucarpidase
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From MedlinePlus, U.S. National Library of Medicine
Carboxypeptidase
Dosing in kidney impairment
Renal Impairment A study of the pharmacokinetics of glucarpidase in the absence of methotrexate in 4 subjects with severe renal impairment (CLcr <30 mL/min) showed that the mean pharmacokinetic parameters were similar to those observed in healthy subjects. On this basis, no dose adjustment of VORAXAZE is recommended for patients with renal impairment [see Clinical Pharmacology].
Preparation and administration
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Preparation Reconstitute the contents of the vial with 1 mL of 0.9% Sodium Chloride Injection, USP. Roll and tilt the vial gently to mix. Do not shake. Inspect the vial and discard VORAXAZE if the solution is not clear, colorless, and free of particulate matter. Use reconstituted VORAXAZE immediately or store under refrigeration at 36° to 46°F (2° to 8°C) for up to 4 hours if not used immediately.
VORAXAZE contains no preservative and is supplied as a single-dose vial. Discard any unused product.
Drug interactions
Check glucarpidase against a medication listLabel text (3 paragraphs)
7 DRUG 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 [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] . 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 [see Warnings and Precautions ( 5.2 )] . When measuring methotrexate concentration following a VORAXAZE dose, a chromatographic method is preferred over an immunoassay.
Contraindications
None. None.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on VORAXAZE use in pregnant women or animal reproduction studies to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. VORAXAZE is administered in combination with methotrexate, which can cause embryo-fetal harm. Refer to methotrexate prescribing information for additional information. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation
8.2 Lactation Risk Summary There are no data on the presence of glucarpidase in human milk or its effects on the breastfed infant or on milk production. VORAXAZE is administered in combination with methotrexate. Refer to methotrexate prescribing information for additional information.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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