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PEDMARK: the first and only
FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity1‑3
Not actual patient.
Not actual patient.
PEDMARK: the first and only
FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity1‑3
Not actual patient.
Recommended for the Adolescent and Young Adult population* by the National Comprehensive Cancer Network® (NCCN®)
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 CIO in pediatric/AYA 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.
CIO=cisplatin-induced ototoxicity; NCCN=National Comprehensive Cancer Network.
PEDMARK is not substitutable with other sodium thiosulfate products.
- Ready to administer–no mixing required
For use in patients 1 month of age and older with localized, non‑metastatic, solid tumors1
- 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
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International Childhood Liver Tumor Strategy Group Study (SIOPEL 6)1
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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Children’s Oncology Group Study (COG ACCL0431)
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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PEDMARK is the first and only FDA-approved STS formulation for cisplatin-induced ototoxicity
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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Plan for PEDMARK
PEDMARK must be infused as directed to minimize potential interference with the antitumor activity of cisplatin.1
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IMPORTANT SAFETY INFORMATION
- PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.
- Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
- PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
- Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.
- Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73 m2.
- Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.
- The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK.
INDICATIONS AND USAGE
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.