INTERACTIONS Formal drug interaction studies have not been conducted with Sodium Thiosulfate Injection.
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 )
AND PRECAUTIONS Hypersensitivity : Immediately discontinue PEDMARK and institute appropriate care. Administer premedications before each subsequent dose. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions. ( 5.1 ) Hypernatremia and Hypokalemia : PEDMARK is not indicated for use in pediatric patients less than 1 month of age. Monitor serum sodium and potassium at baseline and as clinically indicated. Withhold PEDMARK in patients with serum sodium greater than 145 mmol/L ( 5.2 ) Nausea and Vomiting : Administer antiemetics prior to each PEDMARK administration. ( 5.3 )
5.1 Hypersensitivity Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span>. PEDMARK is contraindicated in patients with a history of severe hypersensitivity to sodium thiosulfate or its components <span class="opacity-50 text-xs">[see Contraindications (4) ]</span>. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs <span class="opacity-50 text-xs">[see Dosage and Administration (2.4) ]</span> . Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) ]</span> . PEDMARK may contain sodium sulfite. Sulfite exposure can cause hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes, in patients with sulfite sensitivity. The overall prevalence of sulfite sensitivity in the general population is unknown; sulfite sensitivity is seen more frequently in people with asthma compared to people without asthma.
5.2 Hypernatremia and Hypokalemia At the recommended dosage of PEDMARK, a 20 g/m 2 dose delivers a sodium load of 162 mmol/m 2 , a 15 g/m 2 dose delivers a sodium load of 121 mmol/m 2 and a 10 g/m 2 dose delivers a sodium load of 81 mmol/m 2 . Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span>. Pediatric patients younger than 1 month have less well-developed sodium homeostasis compared to other pediatric patients. PEDMARK is not indicated and not recommended for use in pediatric patients younger than 1 month of age. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Do not initiate PEDMARK infusions in patients with baseline serum sodium greater than 145 mmol/L <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.2) , Dosage and Administration (2.3) ]</span> . Withhold PEDMARK in patients with serum sodium greater than 145 mmol/L <span class="opacity-50 text-xs">[see Clinical Pharmacology (12.2) , Dosage and Administration (2.4) ]</span> . Monitor for signs and symptoms of hypernatremia and hypokalemia. Provide supportive care and supplementation as appropriate.
5.3 Nausea and Vomiting Nausea occurred in 8% to 40% of patients in clinical trials, with Grade 3 or 4 in 3.8 to 8%. Vomiting occurred in 7% to 85% of patients in clinical trials, with Grade 3 or 4 in 7% to 8% <span class="opacity-50 text-xs">[see Adverse Reactions (6.1) ]</span>. Administer antiemetics prior to each PEDMARK administration <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) ]</span> . Provide additional antiemetics and supportive care as appropriate.