SAFETY

Most Common Adverse Reactions With Voraxaze (glucarpidase) Treatment¹

Adverse reactions ≥1% possibly, probably, or definitely related to VORAXAZE¹

Adverse reaction	N=290, n (%)
Paresthesia	7 (2%)
Flushing*	5 (2%)
Nausea/vomiting	5 (2%)
Headache	2 (1%)
Hypotension	2 (1%)

Adverse reaction severity was rated as Grade 1 or Grade 2 for all events, except for 1 patient who reported Grade 3 flushing¹
Adverse reactions related to toxic MTX levels due to prolonged MTX clearance included myelosuppression, mucositis, acute hepatitis, and renal dysfunction and failure¹

^*
This adverse reaction includes the following terms: flushing, feeling hot, burning sensation.

MTX, methotrexate.

CHOOSE VORAXAZE FOR RAPID, NONRENAL ELIMINATION OF TOXIC MTX¹

Administration of VORAXAZE, when indicated, should optimally occur within 48-60 hours from the start of the HDMTX infusion because life-threatening toxicities may not be preventable beyond this time point.²

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Important Safety Information

Warnings and Precautions

Serious Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic reactions, may occur. Serious hypersensitivity reactions occurred in less than 1% of patients

Monitoring Methotrexate Concentration/Interference With Assay

Methotrexate concentrations within 48 hours following Voraxaze^® administration can only be reliably measured by a chromatographic method due to interference from metabolites. Measurement of methotrexate concentrations within 48 hours of Voraxaze^® administration using immunoassays results in an overestimation of the methotrexate concentration

Adverse Reactions

In clinical trials, the most common related adverse events (occurring in >1% of patients) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache

Drug Interactions

Voraxaze^® can decrease leucovorin concentration, which may decrease the effect of leucovorin rescue unless leucovorin is dosed as recommended, and may also reduce the concentrations of other folate analogs or folate analog metabolic inhibitors

Indication and limitations of use

Voraxaze^® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) due to impaired renal function
Limitations of Use: Voraxaze^® is not recommended for use in patients who exhibit the expected clearance and expected plasma methotrexate concentration. Reducing plasma methotrexate concentration in these patients may result in subtherapeutic exposure to methotrexate