Pedmark FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2022.
FDA Approved: Yes (First approved September 20, 2022)
Brand name: Pedmark
Generic name: sodium thiosulfate
Dosage form: Injection
Company: Fennec Pharmaceuticals Inc.
Treatment for: Prevention of Cisplatin-Induced Ototoxicity
Pedmark (sodium thiosulfate) is a cisplatin neutralizing agent used to reduce the risk of ototoxicity associated with cisplatin chemotherapy.
- Pedmark 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.
- Cisplatin-induced ototoxicity is caused by irreversible damage to hair cells in the cochlea. Pedmark is thought to reduce the risk of ototoxicity by interacting directly with cisplatin to produce an inactive platinum species, and acting intracellularly to increase glutathione levels and inhibiting intracellular oxidative stress.
- Pedmark is administered as an intravenous infusion over 15 minutes starting 6 hours after completion of the cisplatin infusion.
- Warnings and precautions associated with Pedmark include hypersensitivity reactions; hypernatremia and hypokalemia; and nausea and vomiting.
- Common adverse reactions include nausea, vomiting, decreased hemoglobin, hypernatremia, and hypokalemia.
Development timeline for Pedmark
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
