American Regent, Inc. introduces FDA-approved Multrys™ (trace elements injection 4*, USP). Multrys™ is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
"We are pleased to offer another FDA-approved multiple trace elements injection specifically developed to more closely align with the American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for trace element supplementation than previously marketed products.
3 This new formulation, which is manufactured in America, has been designed to meet the special needs of the neonatal and pediatric patient population and is part of our overall initiative to retire our line of marketed unapproved trace element products," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. "The launch of Multrys™ demonstrates American Regent's continued commitment to addressing the needs of patients who require trace element supplementation."
Important Administration Information:
Multrys is supplied as a single-dose vial. Prior to administration, Multrys must be transferred to a separate parenteral nutrition container, diluted, and used as an admixture in parenteral nutrition solution.
Overview of Dosing
Prior to administration of parenteral nutrition solution containing Multrys, correct severe fluid, electrolyte and acid-base disorders. It is recommended only for patients who require supplementation with all four of the individual trace elements (zinc, copper, manganese and selenium). Multrys is not recommended for patients who may require a lower dosage of one or more of the individual trace elements. Avoid additional manganese supplementation with Multrys use.
Contraindicated in patients with hypersensitivity to zinc or copper.
Vein Damage and Thrombosis: Solution with an osmolarity of 900 mOsmol/L or greater must be infused through a central catheter.
Neurologic Toxicity with Manganese: Monitor for clinical signs and symptoms of neurotoxicity, whole blood manganese concentrations, and liver function tests. Discontinue Multrys and consider brain magnetic resonance imaging (MRI) if toxicity is suspected. Monitor patients for cholestasis or other biliary liver disease.
Hepatic Accumulation of Copper and Manganese: Assess for development of hepatic accumulation. Monitor concentrations of copper and manganese in patients with cholestasis or cirrhosis.
Aluminum Toxicity: Multrys contains aluminum that may be toxic. Patients with renal impairment and preterm infants, including preterm neonates, are particularly at risk.
Monitoring and Laboratory Tests: Monitor blood zinc, copper and selenium serum concentrations, whole blood manganese concentration, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count, and coagulation parameters.
Hypersensitivity Reactions with Zinc and Copper: If hypersensitivity reactions occur, discontinue and initiate appropriate medical treatment.
About American Regent:
American Regent, Inc., a Daiichi Sankyo Group company, is a leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, we have been a leader in IV iron therapy.
American Regent is committed to US based manufacturing. To that end, over the last several years, we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future.
Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.
For more information, please visit www.americanregent.com.