American Regent has announced the launch and availability of its FDA-approved Selenious Acid Injection, USP. The product is indicated for adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Selenium, an antioxidant, plays a vital role in maintaining immune system health. It helps lower oxidative stress in the body, which reduces inflammation and enhances immunity. Higher levels of selenium may benefit patients with compromised immune systems, such as patients with HIV, influenza, tuberculosis, or hepatitis C.

The product, available for immediate shipment in 600 mcg/10 ml dosing, is supplied as a pharmacy bulk package for admixing use—not for direct intravenous infusion. It will permit delivery of the recommended dose of selenium in a smaller volume than the previously available marketed unapproved product.

While there are no contraindications for the product, warnings and precautions include watching for pulmonary embolism due to pulmonary vascular precipitates; vein damage and thrombosis; and aluminum toxicity, especially in preterm infants.

Monitoring and laboratory tests throughout treatment are recommended.

Administration of the recommended dose shows no adverse effects for pregnant patients.  Safety and dosing recommendations for pediatric patients are based on clinical experience, and dose selection for geriatric patients should be individualized based on the patient’s needs.


Reference

American Regent Announces the Launch and Availability of Selenious Acid Injection, USP [news release]. Shirley, NY; July 8, 2019: American Regent website. https://www.americanregent.com/media/2471/pp-sb-us-0003_seleniousacid_pressrelease_08jul2019.pdf. Accessed July 11, 2019.