FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin
PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
- PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
- The FDA reminded health care providers that as stated in PEDMARK’s prescribing information , PEDMARK is not substitutable with other sodium thiosulfate products.
- Sodium nitrite is co-packaged with sodium thiosulfate as a separate vial in some products; it is not present in PEDMARK.
- The FDA encourages those with any questions to contact [email protected].