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Pedmark Generic Name & Formulations
Legal Class
General Description
How Supplied
Single-dose vial (100mL)—1
Manufacturer
Pedmark Indications
Indications
To reduce the risk of ototoxicity associated with cisplatin in patients ≥1 month of age with localized, non-metastatic solid tumors.
Limitations of Use
Safety and efficacy has not established when administered following cisplatin infusions longer than 6 hours. May not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Pedmark Dosage and Administration
Adults and Children
<1month: not established. Give by IV infusion over 15mins. Premedicate with antiemetics prior to each infusion. To minimize potential interference with antitumor activity of cisplatin: administer Pedmark 6hrs after completion of a cisplatin infusion; for multiday cisplatin regimens, give Pedmark 6hrs after completion of each cisplatin infusion and at least 10hrs before the next cisplatin infusion (do not give Pedmark if next cisplatin infusion is scheduled to begin in <10hrs). ≥1month (<5kg): 10g/m2; (5–10kg): 15g/m2; (≥10kg): 20g/m2. Dose modifications: see full labeling.
Pedmark Contraindications
Not Applicable
Pedmark Boxed Warnings
Not Applicable
Pedmark Warnings/Precautions
Warnings/Precautions
Not substitutable with other sodium thiosulfate products. Ensure serum sodium level is within normal range prior to initiation. Discontinue immediately if hypersensitivity reactions occur; treat appropriately. Sulfite sensitivity. Asthma. Monitor serum sodium and potassium levels at baseline, and as clinically indicated. Do not initiate if baseline serum sodium >145mmol/L. Monitor for signs/symptoms of hypernatremia or hypokalemia more closely if the GFR falls <60mL/min/1.73m2. Pregnancy. Nursing mothers.
Pedmark Pharmacokinetics
See Literature
Pedmark Interactions
Not Applicable
Pedmark Adverse Reactions
Adverse Reactions
Vomiting, nausea, decreased hemoglobin, hypernatremia, hypokalemia; hypersensitivity reactions.
Pedmark Clinical Trials
See Literature
Pedmark Note
Not Applicable
Pedmark Patient Counseling
See Literature
