BTG Specialty Pharmaceuticals advances global regulatory program for glucarpidase, sold as Voraxaze in the US - Seite 2

Voraxaze is also being independently studied in Europe and the US to explore whether routinely giving Voraxaze in combination with high-dose methotrexate might alleviate toxicity, manage the risk to patients and help them to complete therapy. Enrollment in these studies is ongoing. For more information about these studies, or to contact an investigator about participation, please visit ClinicalTrials.gov. 

About Ohara Pharmaceutical Co., Ltd.
Ohara Pharmaceutical Co., Ltd. is a pharmaceutical company that discovers and develops orphan drugs and generic drugs as its mainstay business. The company particularly focuses on the development, manufacturing and marketing of orphan drugs for pediatric cancer and other areas, and on the development, manufacturing and marketing of generic drugs that feature in the prevention of medical accidents. Ohara Pharmaceutical aims to become a company that provides a total healthcare solution by promoting innovations not only in treatment, but also for the prevention, diagnosis and aftercare that affect the quality of healthcare in the substantially changing healthcare environment and improving the treatment outcome.

About BTG Specialty Pharmaceuticals.
BTG Specialty Pharmaceuticals provides antidotes that counteract the potentially life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom there are limited or no existing treatment options. We are dedicated to delivering quality medicines that make a real difference to patients through the development, manufacture, and commercialisation of pharmaceutical products. To learn more about BTG Pharmaceuticals, please visit: btgsp.com.

VORAXAZE 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

IMPORTANT SAFETY INFORMATION