Pedmark Dosage

Generic name: SODIUM THIOSULFATE 12.5g in 100mL
Dosage form: injection, solution
Drug class: Antineoplastic detoxifying agents

Medically reviewed by Drugs.com. Last updated on Sep 30, 2022.

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)].

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/m2
5 to 10 kg	15 g/m2
Greater than 10 kg	20 g/m2

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)].

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)].

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.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 4	Permanently discontinue PEDMARK.

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.