American Regent Announces the
`Launch and Availability of Selenious
`Acid Injection, USP
`
`NEWS PROVIDED BY
`American Regent, Inc.
`Jul 10, 2019, 13:00 ET
`
`
`
`SHIRLEY, N.Y., July 10, 2019 /PRNewswire/ -- American Regent today announced
`the introduction of Selenious Acid Injection, USP.
`
`Selenious Acid Injection, USP is supplied as a 10 mL pharmacy bulk package vial in a
`strength of 600 mcg/10 mL.
`
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`
`Launch and Availability of Selenious
`Acid Injection, USP
`
`NEWS PROVIDED BY
`American Regent, Inc.
`Jul 10, 2019, 13:00 ET
`
`
`
`SHIRLEY, N.Y., July 10, 2019 /PRNewswire/ -- American Regent today announced
`the introduction of Selenious Acid Injection, USP.
`
`Selenious Acid Injection, USP is supplied as a 10 mL pharmacy bulk package vial in a
`strength of 600 mcg/10 mL.
`
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`"We are pleased to offer the first FDA approved Selenious Acid Injection -
`developed to reflect the American Society for Parenteral and Enteral Nutrition
`(ASPEN) recommendations for trace element supplementation. This approval
`1
`underscores our commitment to the parenteral nutrition market in the long term,"
`stated Harsher Singh, Chief Commercial and Strategic Officer at American
`Regent, Inc. In addition, the newly approved product will permit delivery of the
`recommended dose of Selenium in a smaller volume than the previously available
`marketed unapproved product.
`
`Product is available for immediate shipment. Customers can order Selenious
`Acid Injection, USP through their wholesaler/distributor or by contacting our
`Customer Support Group at 1-800-645-1706.
`
`Selenious Acid Injection, USP is supplied as follows:
`
`Pack NDC#
`
`0517-6560-25
`
`Strength
`600 mcg/10 mL (60 mcg/ mL)
`
`Supplied As
`
`Shelf Pack
`
`10 mL Pharmacy Bulk Package Vial
`
`25
`
`See the following Important Safety Information in addition to the Full Prescribing
`Information.
`
`For additional information, please visit americanregent.com.
`
`Reference: 1. Vanek et al. ASPEN position paper: recommendations for changes in
`commercially available parenteral multivitamin and multi-trace element products.
`Nutr Clin Pract. 2012 Aug; 27 (4):440-91.
`
`PP-SB-US-0003 7/2019
`
`SELENIOUS ACID INJECTION, USP
`For intravenous use
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`INDICATIONS AND USAGE
`Selenious Acid Injection is indicated in adult and pediatric patients as a source of
`selenium for parenteral nutrition (PN) when oral or enteral nutrition is not possible,
`insufficient, or contraindicated.
`
`Important Administration Information
`Selenious Acid Injection is supplied as a pharmacy bulk package for admixing use
`only. It is not for direct intravenous infusion.
`
`IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
`None
`
`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: Selenious Acid Injection has a low pH and must be
`prepared and used as an admixture in PN solutions. Solutions with osmolarity of
`900 mOsm/L or more must be infused through a central venous catheter.
`
`Aluminum Toxicity: Selenious Acid Injection contains aluminum that may be toxic.
`Aluminum may reach toxic levels with prolonged parenteral administration if
`kidney function is impaired. Preterm infants are particularly at risk for aluminum
`toxicity because their kidneys are immature, and they require large amounts of
`calcium and phosphate solutions, which also contain aluminum. \
`
`Monitoring and Laboratory Tests: Monitor selenium concentrations, fluid and
`electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood
`count and coagulation parameters throughout treatment.
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`ADVERSE REACTIONS
`No selenium-related adverse reactions have been reported in clinical studies or
`postmarketing reports in patients receiving intravenously administered PN
`solutions containing selenious acid within the recommended dosage range.
`
`USE IN SPECIFIC POPULATIONS
`Pregnancy: Risk Summary: Administration of the recommended dose of Selenious
`Acid Injection in PN is not expected to cause major birth defects, miscarriage, or
`adverse maternal or fetal outcomes.
`
`Lactation: Risk Summary: Selenium is present in human milk. There is no
`information on the effects of selenious acid on milk production. The
`developmental and health benefits of breastfeeding should be considered along
`with the mother's clinical need for Selenious Acid Injection and any potential
`adverse effects on the breastfed infant from Selenious Acid Injection or from the
`underlying maternal condition.
`
`Pediatric Use: Safety and dosing recommendations in pediatric patients are based
`on clinical experience.
`
`Geriatric Use: Dose selection should be individualized based on the patient's
`clinical condition, nutritional requirements, and additional nutritional intake
`provided orally or enterally to the patient.
`
`For additional safety information, please see Full Prescribing Information.
`
`You are encouraged to report Adverse Drug Events (ADEs) to American Regent:
`Email: pv@americanregent.com; Fax: 1-610-650-0170;
`Phone: 1-800-734-9236
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`ADEs may also be reported to the FDA at 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. is a Daiichi Sankyo Group company with over $1B in U.S.
`sales. American Regent develops, manufactures and supplies high-quality sterile
`injectables for healthcare providers and their patients.
`
`Supporting patient health is the guiding principle of American Regent and their
`promise is to provide the healthcare marketplace with a steady supply and broad
`portfolio of branded and generic specialty injectables. American Regent is a top-10
`injectable supplier in therapeutic areas including IV additives, anti-inflammatories,
`diuretics, cytotoxics and diagnostic dyes. Additionally, for nearly 20 years,
`American Regent has been a leader in IV iron therapy and supplies two of the top-
`selling brands in the U.S. today.
`
`For more information, please visit www.americanregent.com.
`
`About Daiichi Sankyo
`Daiichi Sankyo Group is dedicated to the creation and supply of innovative
`pharmaceutical products to address diversified, unmet medical needs of patients
`in both mature and emerging markets. With over 100 years of scientific expertise
`and a presence in more than 20 countries, Daiichi Sankyo and its 15,000
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`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 hypertension and thrombotic disorders, under the
`Group's 2025 Vision to become a "Global Pharma Innovator with Competitive
`Advantage in Oncology," Daiichi Sankyo research and development is primarily
`focused on bringing forth novel therapies in oncology, including immuno-
`oncology, with additional focus on new horizon areas, such as pain management,
`neurodegenerative diseases, heart and kidney diseases, and other rare diseases. 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.
`
`Related Links
`https://www.americanregent.com
`
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