PEDMARK 12.5 g/100mL
SODIUM THIOSULFATE · INJECTION, SOLUTION · Fennec Pharmaceuticals Inc.
PEDMARK is a injection, solution containing sodium thiosulfate at 12.5 g/100mL, taken intravenous. Manufactured by Fennec Pharmaceuticals Inc..
Key Facts
- Brand Name
- PEDMARK
- Generic Name
- SODIUM THIOSULFATE
- NDC Code (Product)
73077-010- Manufacturer
- Fennec Pharmaceuticals Inc.
- Strength
- 12.5 g/100mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA212937
- Marketing Start
- 10/03/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. 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. 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. ( 1 ) 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION PEDMARK is not substitutable with other sodium thiosulfate products. ( 2 ) The recommended dose of PEDMARK is based on surface area according to actual body weight. Administer PEDMARK as an intravenous infusion over 15 minutes starting 6 hours after completion of cisplatin infusion. For multiday cisplatin regimens, administer PEDMARK 6 hours after each cisplatin infusion but at least 10 hours before the next cisplatin infusion. Do not start PEDMARK if less than 10 hours before starting the next cisplatin infusion ( 2 ) Actual Body Weight PEDMARK Dose Less than 5 kg 10 g/m 2 5 to 10 kg 15 g/m 2 Greater than 10 kg 20 g/m 2 2.1 Important Dosing Information PEDMARK is not substitutable with other sodium thiosulfate products. Ensure serum sodium level is within normal range prior to initiating PEDMARK [see Warnings and Precautions (5.2) ] . 2.2 Recommended Dosage and Administration The recommended dose of PEDMARK is based on surface area according to actual body weight as summarized in Table 1. Table 1. Recommended Dose for PEDMARK Actual Body Weight PEDMARK Dose Less than 5 kg 10 g/m 2 5 to 10 kg 15 g/m 2 Greater than 10 kg 20 g/m 2 Administer PEDMARK as an …
Contraindications
4 CONTRAINDICATIONS PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components [see Warnings and Precautions (5.1) ] . History of severe hypersensitivity to sodium thiosulfate or any components. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hypernatremia and Hypokalemia [see Warnings and Precautions (5.2) ] Nausea and Vomiting [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥ 25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 are vomiting, nausea, decreased hemoglobin, and hypernatremia. ( 6 ) Most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 is hypokalemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fennec Pharmaceuticals, Inc. at 1-833-336-6321, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. SIOPEL 6 The safety of PEDMARK was evaluated in SIOPEL 6 [see Clinical Studies (14) ]. Patients received cisplatin-based chemotherapy with or …
Frequently Asked Questions
What is PEDMARK used for?
PEDMARK contains SODIUM THIOSULFATE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is PEDMARK a controlled substance?
PEDMARK is not classified as a controlled substance by the DEA.
What is the generic name for PEDMARK?
The generic name for PEDMARK is SODIUM THIOSULFATE. There are 1 other brand versions of SODIUM THIOSULFATE.
What is the NDC code for PEDMARK 12.5 g/100mL?
The NDC (National Drug Code) for PEDMARK 12.5 g/100mL is 73077-010, listed by Fennec Pharmaceuticals Inc..