Selenious Acid Drug Information

Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

• No selenium-related adverse reactions have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range. The following adverse reactions associated with use of other components of parenteral nutrition solutions were identified in clinical studies or postmarketing reports. Because some of these reactions were 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:
• Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )]
• Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )]
• Aluminum toxicity [see Warnings and Precautions ( 5.3 )] No selenium-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range. To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Pregnancy Risk Summary Administration of the recommended dose of Selenious Acid Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous selenious acid. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including selenium, is associated with adverse pregnancy and fetal outcomes.

Pregnant women have an increased metabolic demand for trace elements, including selenium. Parenteral nutrition with selenium should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

Pediatric Use Selenious Acid Injection is approved for use in the pediatric population, including neonates, as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on clinical experience. Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Selenious Acid Injection may be at higher risk of aluminum toxicity.

There are no known cases of overdosage with intravenous selenious acid in parenteral nutrition. Overdosage has been reported with oral selenium. Available selenium concentrations in these subjects have been reported using various assays and laboratory-based reference ranges over a period of time.

Interpret results in the context of current reported ranges. For oral selenium, the Tolerable Upper Limit (UL) is 400 mcg/day and the No Observed Adverse Effect Level (NOAEL) is 800 mcg/day. The estimated oral bioavailability of selenium is approximately 70%. Acute Oral Toxicity Effects Serious adverse events and deaths have been reported with acute oral toxicity, however, there is no clear correlation between the amount ingested, signs and symptoms of toxicity, or selenium blood concentrations.

With severe toxicity, the most common presenting symptoms within a few hours post-ingestion of oral doses greater than 1 gram/day of selenium are gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), altered mental status, and “garlic” breath odor. Death from circulatory collapse has been reported after oral ingestion of 5 to 10 grams of selenium. Selenium serum or blood concentrations in fatal cases have been reported in the range of 190 mcg/dL to 3,800 mcg/dL. Mild to moderate intoxication (myalgia, muscle spasms, and irritability) has been reported in patients with selenium serum or blood concentrations in the range of 41 to 750 mcg/dL. Chronic Selenosis Chronic daily exposure to selenium from dietary sources (0.003 to 0.007 grams/day) or oral supplements (0.0016 to 0.25 grams/day) may result in alopecia and nail brittleness.

Other signs include gastrointestinal disturbances, skin rash, garlic breath, fatigue, irritability, and nervous system abnormalities including paresthesia and ataxia. Selenium serum or blood concentrations in patients in China exposed through oral (non-dietary) supplementation were in the range of 32 to 150 mcg/dL. Management There is no known antidote for acute selenium toxicity. Management of selenium overdosage is supportive care based on presenting signs and symptoms.