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These recommendations are not consistent with the FDA indication. Always refer to the PEDMARK Prescribing Information and Instructions for Use.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Adolescent and Young Adult (AYA) Oncology recommends sodium thiosulfate (PEDMARK) as a preventative treatment option to reduce hearing loss associated with platinum-based chemotherapy in patients with localized, nonmetastatic solid tumors.4
*NCCN Guidelines® define an adolescent or young adult (AYA) oncology patient as an individual between 15 and 39 years.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
NCCN=National Comprehensive Cancer Network.
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Patients aged 1 month to 18 years receiving cisplatin chemotherapy for the treatment of histologically confirmed, newly diagnosed standard risk hepatoblastoma.1
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Patients aged 1 to 18 years receiving cisplatin chemotherapy for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or any other malignancy treated with cisplatin.1
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No generic approved product exists or can be directly compared; PEDMARK is not substitutable with any other sodium thiosulfate (STS) formulation.1
PEDMARK is the only unique sodium thiosulfate formulation that has been evaluated in randomized clinical trials for its safety and efficacy in patients 1 month and older1; the results are published in Lancet Oncology and The New England Journal of Medicine.5,6
No other STS formulation has been tested for interaction with bioactive, unbound platinum, a critical factor for tumor protection.7,8
The approved PEDMARK formulation has undergone more than 10 years of study.5,6,9
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PEDMARK must be infused as directed to minimize potential interference with the antitumor activity of cisplatin.1
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Please see full Prescribing Information for PEDMARK.
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non‑metastatic solid tumors.
Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.