Pedmark

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 intravenous infusion over 15 minutes, following cisplatin infusions that are 1 to 6 hours in duration [see Indications and Usage (1) ] .
• Infuse PEDMARK as described below to minimize the potential interference with the antitumor activity of cisplatin [see Clinical Pharmacology (12.1) , Clinical Studies (14) ].
• Administer PEDMARK 6 hours after completion of a cisplatin infusion.
• For multiday cisplatin regimens, administer PEDMARK 6 hours after completion of each cisplatin infusion and at least 10 hours before the next cisplatin infusion.
• Do not administer PEDMARK if the next cisplatin infusion is scheduled to begin in less than 10 hours [see Clinical Pharmacology (12.3) , Clinical Studies (14) ].
• 2.3 Recommended Premedications Administer antiemetics before each PEDMARK infusion [see Warnings and Precautions (5.3) ] .
• For patients who experience a hypersensitivity reaction, administer antihistamines and glucocorticoids (if appropriate) before each subsequent PEDMARK infusion [see Warnings and Precautions (5.1) ].
• 2.4 Dosage Modifications for Adverse Reactions The recommended dosage modifications for adverse reactions are provided in Table 2.
• Table 2.
• Recommended PEDMARK Dosage Modifications for Adverse Reactions Adverse Reaction Severity Dosage Modification Hypersensitivity [see Warnings and Precautions (5.1) ] Grade 3 or 4 Permanently discontinue PEDMARK.
• Hypernatremia [see Warnings and Precautions (5.2) ] >145 mmol/L Withhold PEDMARK until sodium is within normal limits.
• Resume at the same dose.
• Hypokalemia [see Warnings and Precautions (5.2) ] Grade 3 or 4 Withhold PEDMARK until potassium is within normal limits.
• Resume at the same dose.
• Other Adverse Reactions [see Adverse Reactions (6.1) ] Grade 3 Withhold until ≤ Grade 1.
• Resume at the same dose.
• Grade 4 Permanently discontinue PEDMARK.
• 2.5 Preparation Calculate the dose (grams) and determine the number of vial(s) needed.
• Visually inspect the contents of the vial for particulate matter and discoloration.
• Discard the vial(s) if discolored or contains visible particulates.
• Withdraw the calculated dose from the vial(s) into a syringe or transfer the calculated dose into an empty infusion bag.
• Use immediately after withdrawing into a syringe or transferring to an empty infusion bag.
• If not used immediately, PEDMARK can be stored in an infusion bag for no more than 18 hours at 20°C to 22°C (68°F to 72°F).
• Discard unused portion.
• No incompatibilities have been observed between PEDMARK with infusion bags made of polyvinyl chloride, ethylene vinyl acetate, or polyolephin.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

• The safety and effectiveness of PEDMARK have been established to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.
• The safety and effectiveness of PEDMARK have not been established in pediatric patients younger than 1 month old or in pediatric patients with metastatic cancer.
• PEDMARK is not recommended in pediatric patients younger than 1 month old due to the increased risk of hypernatremia [see Warnings and Precautions (5.2) ] .

Quoted from the official label, section “Pediatric Use”.

Side effects

• 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 without PEDMARK administered at a dose of 10 g/m 2 , 15 g/m 2 , or 20 g/m 2 (depending on body weight) as an intravenous infusion over 15 minutes starting 6 hours after completion of each cisplatin infusion.
• Patients received PEDMARK for a median of 6 cycles (range:
• 2 to 8 cycles) during a median of 94 days (range:
• 2.1 to 5.2 months) of cisplatin-based chemotherapy.
• Serious adverse reactions occurred in 40% of patients who received PEDMARK in combination with cisplatin-based chemotherapy.
• Serious adverse reactions in >5% of patients who received PEDMARK included infection, decreased neutrophil count, and pyrexia.
• PEDMARK was permanently discontinued due to an adverse reaction in 1 patient; this patient discontinued PEDMARK for Grade 2 hypersensitivity.
• The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) were vomiting, nausea, decreased hemoglobin, and hypernatremia.
• Table 3 summarizes the adverse reactions reported in SIOPEL 6.
• Table 3.
• Adverse Reactions (≥10%) in Patients Who Received PEDMARK and Cisplatin with a Difference Between Arms of >5% Compared to Cisplatin Alone in SIOPEL 6 Adverse Reaction PEDMARK + Cisplatin (N = 53) Cisplatin Alone (N = 56) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Gastrointestinal disorders Vomiting 85 8 54
• 3.6 Nausea 40 3.8 30 5 Investigations Decreased Hemoglobin 34 19 29 16 Metabolism and nutrition disorders Hypernatremia 26 1.9 3.6 0 Hypokalemia 15 9 1.8 0 Hypophosphatemia 15 9 1.8 0 Hypermagnesemia 11 9 5
• 3.6 General disorders Pyrexia 15 0 9 0 COG ACCL0431 The safety of PEDMARK was evaluated in COG ACCL0431 [see Clinical Studies (14) ].
• Patients received cisplatin-based chemotherapy with or without PEDMARK, administered at a dose that is bioequivalent to the recommended dose as an intravenous infusion over 15 minutes starting 6 hours after completion of each cisplatin infusion.
• Patients who received PEDMARK were treated for a median of 3 cycles (range:
• 1 to 6) during a median of 15 weeks of cisplatin-based chemotherapy.
• Serious adverse reactions occurred in 36% of patients who received PEDMARK in combination with cisplatin-based chemotherapy.
• Serious adverse reactions in >5% of patients who received PEDMARK included febrile neutropenia, decreased neutrophil count, decreased platelet count, decreased white blood cell count, anemia, stomatitis, infections, decreased lymphocyte count, and increased alanine aminotransferase (ALT).
• PEDMARK was permanently discontinued due to an adverse reaction in 1 patient; this patient discontinued PEDMARK for Grade 2 hypersensitivity.
• The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) was hypokalemia.
• Table 4 summarizes the adverse reactions reported in COG ACCL0431.
• Table 4.
• Adverse Reactions (≥10%) in Patients Who Received PEDMARK and Cisplatin with a Difference Between Arms of >5% Compared to Cisplatin Alone in COG ACCL0431 Adverse Reaction PEDMARK + Cisplatin (N = 59) Cisplatin Alone (N = 64) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Metabolism and nutrition disorders Hypokalemia 27 27 20 20 Hypophosphatemia 20 20 11 11 Hyponatremia 14 12 6 6 Hypernatremia 12 0 6 0 Gastrointestinal disorders Stomatitis 14 14 6 6
• 6.2 Postmarketing Experience/Spontaneous Reports The following adverse reactions have been identified from spontaneous reports based on medical literature.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Cardiovascular Disorders:
• hypertension, hypotension Metabolic and Nutritional Disorders:
• metabolic acidosis, hypocalcemia

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Hypersensitivity Inform patients and caregivers that PEDMARK can cause hypersensitivity reactions [see Warnings and Precautions (5.1) ].
• Hypernatremia and Hypokalemia Inform patients and caregivers that PEDMARK can cause hypernatremia and hypokalemia, and to promptly report signs and symptoms consistent with these electrolyte abnormalities [see Warnings and Precautions (5.2) ].
• Nausea and Vomiting Inform patients and caregivers that PEDMARK can cause nausea and vomiting [see Warnings and Precautions (5.3) ].

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 12.5 grams/100 mL (125 mg/mL) clear, colorless solution in a single-dose vial Injection:
• 12.5 grams/100 mL in a single-dose vial. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• PEDMARK (sodium thiosulfate injection) is a clear, colorless, sterile solution in a Type 1 Plus borosilicate glass single-dose vial with rubber stopper and capped with aluminum overseal, supplied as:
• 12.5 grams/100 mL (125 mg/mL) single-dose vial, NDC 73077-010-01
• Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F).

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F).

Quoted from the official label, section “Storage and Handling”.

What is in it

• Sodium thiosulfate anhydrous is an inorganic salt with a molecular formula of Na 2 S 2 O 3 and a molecular weight of 158.11 g/mol.
• The structural formula is:
• It is a white to off-white crystalline solid that is soluble in water, but insoluble in alcohol.
• The aqueous solution has a pH ranging from 6.5 to 8.0.
• PEDMARK (sodium thiosulfate injection) is a sterile, preservative-free, clear, colorless solution in a single-dose vial for intravenous use with a pH between 7 and 9.
• Each vial contains the equivalent of 12.5 grams of sodium thiosulfate pentahydrate (provided as sodium thiosulfate anhydrous 8 grams) in 100 mL solution (125 mg/mL).
• Each mL contains the equivalent of 125 mg of sodium thiosulfate pentahydrate (provided as sodium thiosulfate anhydrous 80 mg) and 0.25 mg boric acid.
• Sodium hydroxide and hydrochloric acid may have been used for pH adjustment.
• Chemical Structure

Quoted from the official label, section “Description”.

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Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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