American Regent Introduces Tralement™ (trace elements injection 4*, USP)

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Sep 30, 2020, 14:00 ET

MELVILLE, N.Y., Sept. 30, 2020 /PRNewswire/ -- American Regent, Inc. announces the introduction of Tralement™ (trace elements injection 4*, USP), the first and only FDA-approved multi-trace element injection.¹ Tralement^TM is indicated in adult and pediatric patients weighing at least 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.²

Tralement is supplied in a glass 1 mL single dose vial. *Each mL provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg.

"We are pleased to offer the first FDA-approved multiple trace elements injection, which has been specifically developed to align with the American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for trace element supplementation.³ The concentration of each element in new Tralement^TM has been formulated to meet the needs of a broad range of patients," stated Joann Gioia, Associate Vice President, Commercial Operations and National Accounts at American Regent, Inc. "This launch demonstrates American Regent's commitment to meeting the high bar of a new drug approval, and also serves to address the FDA's safety initiative for unapproved products."⁴

Looking forward, American Regent has committed to addressing the needs of special patient populations through the expansion of the Tralement™ product line. In addition, American Regent has made significant investments in its manufacturing infrastructure to help ensure a continuous supply of Tralement^TM.

This product is available for immediate shipment. Customers can order Tralement^TM through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.

Tralement™ (trace elements injection 4*, USP) is supplied as follows:

Pack NDC#

Strength

Supplied As

Shelf Pack

0517-9305-25

*zinc 3 mg, copper 0.3 mg, manganese 55 mcg,
and selenium 60 mcg per 1 mL

1 mL

Single Dose Vial

Please note that American Regent will cease distribution of Multitrace^®-5 Concentrate (NDC# 0517-8201-25) upon distribution of Tralement™. Multitrace^®-4 Pediatric (NDC #0517-9203-25) and Multitrace^®-4 Neonatal (NDC# 0517-6202-25) will continue to be distributed in order to meet market demand.

See the following Important Safety Information, in addition to the product's Full Prescribing Information. For additional information, please visit https://www.americanregent.com.

References

Approved Drug Products with Therapeutic Equivalence Evaluations: https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=209376#121. Accessed August 4, 2020.
TRALEMENT^TM (trace elements injection 4*, USP) [package insert]. Shirley, NY: American Regent, Inc. 2020
American Society for Parenteral and Enteral Nutrition (ASPEN) website: http://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/PN%20Dosing%201-Sheet-FINAL.pdf. Accessed July 1, 2020.
FDA's Concerns about Unapproved Drugs: https://www.fda.gov/drugs/unapproved-drugs/fdas-concerns-about-unapproved-drugs#main-content. Accessed July 1, 2020.

Tralement™ is a trademark of American Regent, Inc.
Patents pending. PP-TR-US-0009 9/2020

Tralement™ (trace elements injection 4*, USP)

For intravenous use

INDICATIONS AND USAGE
Tralement™ is indicated in adult and pediatric patients weighing at least 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.

IMPORTANT SAFETY INFORMATION

Important Administration Information
Tralement is supplied as a single-dose vial for admixture use only. It is not for direct intravenous infusion. Prior to administration, Tralement 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 Tralement, correct severe fluid, electrolyte, and acid-base disorders.
The dosage of the final parenteral nutrition solution containing Tralement must be based on the concentrations of all components in the solution, the patient's clinical condition, nutritional requirements, and the contribution of oral or enteral intake.

Tralement is recommended only for patients who require supplementation with all four of the individual trace elements (i.e., zinc, copper, manganese and selenium).

See Full Prescribing Information on preparation, administration and dosing.

CONTRAINDICATIONS
Tralement is contraindicated in patients with hypersensitivity to zinc or copper.

WARNINGS AND PRECAUTIONS

Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. The primary complication of peripheral access is venous thrombophlebitis.
Neurologic Toxicity with Manganese: Monitor patients receiving long-term parenteral nutrition solutions containing Tralement for neurologic signs and symptoms and routinely monitor whole blood manganese concentrations and liver function tests. Discontinue Tralement and consider brain magnetic resonance imaging (MRI) if toxicity suspected.
Hepatic Accumulation of Copper and Manganese: Assess for development of hepatic or biliary dysfunction. Monitor concentrations of copper and manganese in patients with cholestasis, biliary dysfunction or cirrhosis receiving Tralement long-term.
Aluminum Toxicity: Tralement contains aluminum that may be toxic. Increased risk in patients with renal impairment, including preterm infants.
Monitoring and Laboratory Tests: Monitor blood zinc, copper, manganese, and selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters.
Hypersensitivity Reactions with Zinc and Copper: If reactions occur, discontinue Tralement and initiate appropriate medical treatment.

ADVERSE REACTIONS
The following adverse reactions were identified in clinical studies or post-marketing reports. Given that 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.

Adverse reactions with other components of parenteral nutrition solutions:

Pulmonary embolism due to pulmonary vascular precipitates
Vein damage and thrombosis
Aluminum toxicity

Adverse reactions with the use of trace elements administered parenterally or by other routes of administration:

Neurologic toxicity with manganese
Hepatic accumulation of copper and manganese
Hypersensitivity reactions with zinc and copper

USE IN SPECIFIC POPULATIONS
Pregnancy - Risk Summary - Deficiency of trace elements may result in adverse pregnancy and fetal outcomes.

Lactation - Risk Summary - Zinc, copper, manganese, and selenium are present in human milk. The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for Tralement and any potential adverse effects on the breastfed infant from Tralement or from the underlying maternal condition.

Pediatric Use - Refer to Full Prescribing Information for dosing. Do not supplement Tralement with additional manganese. Tralement is not approved for use in pediatric patients weighing less than 10 kg.

Hepatic Impairment - Hepatic accumulation of copper and manganese have been reported with long-term administration in parenteral nutrition. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of Tralement.

OVERDOSAGE - There are reports on overdosage in the literature for the individual trace elements. Management of overdosage is supportive care based on presenting signs and symptoms.

For additional safety information, please see Full Prescribing Information.

REF-1535 08/2020

You are encouraged to report Adverse Drug Events (ADEs) to American Regent:
Email: [email protected]; Fax: 1-610-650-0170;
Phone: 1-800-734-9236

ADEs may also be reported to the FDA:
1-800-FDA-1088 or to www.fda.gov/medwatch

Drug Information:
1-888-354-4855
(9:00 am – 5:00 pm Eastern Time, Monday – Friday)

For urgent drug information outside of normal business hours, assistance is available at:
1-877-845-6371

About American Regent
American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 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.

About Daiichi Sankyo Group
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group.
For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.

SOURCE American Regent, Inc.