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Efficacy

Within 15 Minutes, Patients Experienced Rapid Reductions in Plasma MTX Concentrations1

At each post-Voraxaze® assessment time point, the median MTX concentration was <0.54 μmol/L, corresponding to a median reduction of ≥97% from pre-Voraxaze® measurements.2

Voraxaze® reduced plasma MTX concentrations by ≥97% within 15 minutes in all 22 treatment-evaluable patients.1

Patients Sustained Reductions in Plasma MTX Concentrations for Up to 8 Days1

0

of patients taking Voraxaze® (20 of 22) achieved sustained reductions for up to 8 days1

0

of patients (10 of 22) achieved rapid and sustained clinically important reduction (RSCIR)1

  • These results are from a single-arm, open-label study in 22 treatment-evaluable patients with markedly delayed MTX clearance secondary to AKI1
  • The primary endpoint of the study was the proportion of patients achieving RSCIR in plasma MTX concentrations (<1 μmol/L) following initial injection1
  • Of the 12 patients who failed to achieve RSCIR, 5 patients (23%) attained a transient plasma methotrexate concentration of <1 μmol/L1

Early Administration of Voraxaze® May Diminish the Risk for Serious Life-Threatening Toxicity and Even Death2,3

Incidence of Grade 4 toxicity was significantly lower with early administration of Voraxaze®2

Graph showing data for early vs late administration of Voraxaze®
  • Administration of Voraxaze® ≤96 hours after HDMTX exposure appeared to protect from the development of toxicity2
  • Grade 4 toxicity developed in only 9/64 (14%) compared to 6/11 (55%) who received Voraxaze® more than 96 hours after starting HDMTX2

Incidence of mortality was significantly lower with early administration of Voraxaze®3

Graph showing data for early vs late administration of Voraxaze®
  • Of 476 patients receiving Voraxaze®, death occurred in 22% of patients treated after >4 days of HDMTX compared to 10.9% treated within 2 days of HDMTX3
  • There are no controlled trials comparing Voraxaze® plus supportive care to supportive care measures alone in patients with toxic plasma MTX concentrations due to impaired renal function; therefore, there are no data regarding the effect of Voraxaze® on survival or toxic death due to MTX. Voraxaze® did not prevent fatal MTX toxicity in 3% of patients in the safety population3

Voraxaze® Delivered Clinically Important MTX Reductions in Markedly Less Time1,4-6

Patients can achieve clinically important reductions in plasma MTX concentrations within 15 minutes vs 5 to 11 days

Graph showing clinically important reductions in MTX concentrations

Trust Voraxaze® for Rapid and Sustained Reductions in MTX

Not every patient requires Voraxaze®, but experts have assembled recommendations to help guide treatment.

Explore the guidelines for the use and stocking of Voraxaze® so that you’re prepared in an emergency.

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References

  1. Voraxaze® [prescribing information]. BTG International Inc; 2013.
  2. Howard SC, et al. Preventing and managing toxicities of high-dose methotrexate. The Oncologist 2016; 21:1-12.
  3. Widemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. J Clin Oncol. 2010; 28:3979-3986.
  4. 2013 Annual Meeting of the North American Congress of Clinical Toxicology (NACCT), Clinical Toxicology 2013; 51(7):575-724. doi:10.3109/15563650.2013.817658.
  5. Ramsey L, Balis FM, O’Brien MM, et al. Consensus guidelines for use of glucarpidase in patients with high-dose methotrexate induced acute kidney injury and delayed methotrexate clearance. Durham, NC. The Oncologist. 2017 Oct 27. doi: 10.1634/theoncologist.2017-0243
  6. Widemann BC, Adamson PC. Understanding and managing methotrexate nephrotoxicity. Oncologist. 2006;11:694-703
  7. Schwartz S, Borner K,Müller K, et al. Glucarpidase (carboxypeptidase G2) intervention in adult and elderly cancer patients with renal dysfunction and delayed methotrexate elimination after high-dose methotrexate therapy. Oncologist. 2007;12:1299-1308.
  8. Widemann BC, Balis FM, Kempf-Bielack B, et al. High-dose methotrexate-induced nephrotoxicity in patients with osteosarcoma. Cancer. 2004;100:2222-2232
  9. Data on file. BTG International Inc. 2012.
  10. de Miguel D, García-Suárez J Martín Y, Gil-Fernández JJ, Burgaleta C. Severe acute renal failure following high-dose methotrexate therapy in adults with haematological malignancies: a significant number result from unrecognized co-administration of several drugs. Nephrol Dial Transplant. 2008;23:3762-3766.
  11. Jahnke K, Korfel A, Martus P, et al; on behalf of the German Primary Central Nervous System Lymphoma Study Group (G-PCNSL-SG). High-dose methotrexate toxicity in elderly patients with primary central nervous system lymphoma. Ann Oncol. 2005;16:445-449
  12. Flombaum C, Meyers P. High-dose leucovorin as sole therapy for methotrexate toxicity. Journal of Clinical Oncology 1999; 17(5): 1589-1594.
  13. Murashima M, et al. Methotrexate clearance by high-flux hemodialysis and peritoneal dialysis: a case report. Am J Kidney Dis 2009; 53:781-874.
  14. Wall S, Johansen M, et al. Effective clearance of methotrexate using high-flux hemodialysis membranes. Am J Kidney Dis 1996; 28(6):846-854.
  15. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.
  16. Green JM. Glucarpidase to combat toxic levels of methotrexate in patients. Ther Clin Risk Manag. 2012;8:403-4
  17. Glucarpidase (Voraxaze®) National Drug Monograph and Considerations for Use. U.S. Department of Veterans Affairs website. 2014. http://www.pbm.va.gov/clinicalguidance/drugmonographs/Glucarpidase_ Drug_Monograph_and_Considerations_for_Use.doc. Published June 2014. Accessed November 04, 2016.
  18. Leucovorin [prescribing information]. Bedford Laboratories; 2011.