LONDON, November 16, 2017 /PRNewswire/ --
BTG plc (LSE: BTG), the global specialist healthcare company,
announces the publication of new consensus guidelines for use of
Voraxaze® (glucarpidase) in patients with high-dose
methotrexate-induced acute kidney injury and delayed methotrexate
clearance in The Oncologist.[1]
(Logo:
http://photos.prnewswire.com/prnh/20150805/255981LOGO )
High-dose methotrexate, defined as a dose higher than 500
mg/m2, is used to treat a range of adult and childhood
cancers, including, osteosarcoma, acute lymphoblastic leukemia, and
primary central nervous system lymphoma. Acute kidney injury due to
high-dose methotrexate is a serious, life-threatening toxicity that
can occur in pediatric and adult patients. Voraxaze®
(glucarpidase) is indicated for the treatment of toxic plasma
methotrexate concentrations (>1 μmol/L) in patients with delayed
methotrexate clearance due to impaired renal function.
Until now, there have been no available consensus guidelines on
the use of Voraxaze®. An international group of
experts was convened to develop a consensus guideline that was
specific and evidence-based to identify the population of patients
who would benefit from Voraxaze®. These new guidelines
recommend that "administration of Voraxaze® 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".
Dr. Peter C. Adamson of the
Children's Hospital of Philadelphia, who is Chair of the Children's
Oncology Group and Professor of Pediatrics, Perelman School of
Medicine at the University of
Pennsylvania, commented, "These guidelines provide a
much-needed framework for how to treat patients with acute kidney
injury secondary to high dose MTX. The publication will provide
clinicians both practical and specific guidance on when and how to
treat patients with glucarpidase to optimize the potential for
benefit."
Suzanne Ward, PharmD, MBA, Senior
Director of Medical Strategy for Specialty Pharmaceuticals at BTG
states: "The medical community has long awaited definitive
expert-consensus on how to manage delayed methotrexate elimination
due to acute kidney injury, including the appropriate timeframe to
intervene with glucarpidase. These guidelines provide very specific
plasma methotrexate concentration thresholds as early as 24 hours
following the start of methotrexate infusion, allowing clinicians
to promptly identify patients at risk so that treatment occurs
without delay, minimizing unnecessary over-exposure to methotrexate
and toxicity progression."
The guideline provides recommendations to identify the
population of patients who would benefit from glucarpidase rescue
by more precisely defining the absolute methotrexate concentrations
associated with risk for severe or life-threatening toxicity at
several time points after the start of a high-dose methotrexate
infusion. Early administration of Voraxaze may diminish the risk
for serious life threatening toxicity and even death.
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have a portfolio of Interventional
Medicine products to advance the treatment of cancer, severe
emphysema, severe blood clots and varicose veins, and Specialty
Pharmaceuticals that help patients overexposed to certain
medications or toxins. Inspired by patient and physician needs, BTG
is investing to expand its portfolio to address some of today's
most complex healthcare challenges. To learn more about BTG, please
visit: btgplc.com .
For further information contact:
BTG
Andy Burrows, VP Corporate &
Investor Relations
+44-(0)-20-7575-1741; Mobile: +44-(0)-7990-530-605
Stuart Hunt, Investor Relations
Manager
+44-(0)-20-7575-1582; Mobile: +44-(0)-7815-778-536
Chris Sampson, Corporate
Communications Director
+44-20-7575-1595; Mobile: +44-7773-251-178
FTI Consulting
Ben Atwell/Simon Conway
+44-(0)-20-3727-1000
[1] A full text version of the article can be
accessed at the following link:
http://theoncologist.alphamedpress.org/content/early/2017/10/27/theoncologist.2017-0243.long
SOURCE BTG plc