Pedmark (sodium thiosulfate)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of severe hypersensitivity to sodium thiosulfate or any components of the formulation.

There are no contraindication contraindications for this drug.

• Hypernatremia
• Hypokalemia

There are no moderate contraindications for this drug.

Most common adverse reactions (>=25% with difference between arms of >5% comparedto cisplatin alone) in the SIOPEL 6 trial include vomiting, nausea, decreased hemoglobin, andhypernatremia.

Most common adverse reaction (>=25% with difference between arms of >5% compared tocisplatin alone) in the COG ACCL0431 trial was hypokalemia.

More Frequent

• Anemia
• Hypernatremia
• Hypokalemia

Less Frequent

• Hypermagnesemia
• Hypophosphatemia

Rare or Very Rare

• Hypertension
• Hypocalcemia
• Hypotension
• Metabolic acidosis

More Frequent

• Headache disorder
• Nausea
• Vomiting

Less Frequent

• Fever
• Stomatitis

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The safety and effectiveness of sodium thiosulfate have been established to reduce the risk of ototoxicity associated with cisplatin in pediatric patients >=1 month of age with localized, non-metastatic solid tumors. The safety and effectiveness of sodium thiosulfate have not been established in pediatric patients <1 month of age or in pediatric patients with metastatic cancer. Sodium thiosulfate is not recommended in pediatric patients <1 month of age due to the increased risk of hypernatremia.

There are no available data on sodium thiosulfate use in pregnant women to evaluate for a drug-associated risk. Oral or IV administration of sodium thiosulfate during the period of organogenesis resulted in no signs of malformations or lethality, but at doses and exposures that were lower than those in humans.

Sodium thiosulfate (Pedmark(R)) is administered following cisplatin infusions, which can cause embryo-fetal harm. Refer to cisplatin prescribing information for additional information.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

In animal studies, sodium thiosulfate was not embryotoxic or teratogenic in pregnant mice, rats, hamsters, or rabbits at daily (5 to 13 daily doses during the period of organogenesis) oral maternal doses of up to 550, 400, 400, and 580 mg/kg/day (0.08 to 0.35 times the highest clinical dose of 20 g/m2 based on body surface area (BSA)), respectively, of sodium thiosulfate; exposure in these animals compared to humans may be much lower due to poor oral bioavailability. Sodium thiosulfate was not embryotoxic or teratogenic in hamsters following a total daily dose of 1500 mg/kg (0.38 times the highest clinical dose of 20 g/m2 based on BSA). Additionally, an IV pharmacokinetic study in gravid ewes indicated that sodium thiosulfate does not cross the placenta.

There are no data on the presence of sodium thiosulfate in human milk or its effects on the breastfed child or on milk production.

The manufacturer states that when sodium thiosulfate is administered in combination with cisplatin to reduce the risk of ototoxicity, refer to the cisplatin prescribing information for additional information.

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