American Regent Introduces Levocarnitine Injection, USP; FDA-Approved, "AP" Rated, and Therapeutically Equivalent to Carnitor®¹

2023-10-10

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SHIRLEY, N.Y., Oct. 10, 2023 /PRNewswire/ -- American Regent announces the release and availability of Levocarnitine Injection, USP, FDA-approved, "AP" rated, and therapeutically equivalent to Carnitor®. Levocarnitine is indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency, and for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease who are undergoing dialysis.

American Regent announces the release and availability of Levocarnitine Injection, USP.

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American Regent Introduces Levocarnitine Injection, USP; FDA-Approved, "AP" Rated, and Therapeutically Equivalent to Carnitor®¹

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来源: PRNewswire

Levocarnitine Injection is supplied as a 5 mL single-dose vial, with a strength of 1 gram/5 mL (200 mg/mL), and as a 20 mL single-dose vial, with a strength of 4 grams/20 mL (200 mg/mL)

"We are pleased to make this crucial medication available to patients who need it. We are equally pleased to add Levocarnitine Injection to our robust line of products, which are formulated, filled, and finished at our US-based manufacturing facilities," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc.

This product is available for immediate shipment. Customers can order

Levocarnitine Injection, USP,

through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.

See the following Important Safety Information, in addition to the product's Full Prescribing Information.

For additional information, please visit www.americanregent.com.

All trademarks are the property of their respective owners.

References:

1. Orange book: Approved drug products with therapeutic equivalence evaluations. U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=075861#25307.

Accessed April 27, 2023.

PP-LI-US-0006

Levocarnitine Injection, USP

For intravenous use only

INDICATIONS AND USAGE

For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.

For the prevention and treatment of carnitine deficiency in patients with end-stage renal disease who are undergoing dialysis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None known.

WARNINGS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine administration, mostly in patients with end-stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine.

If a severe hypersensitivity reaction occurs, discontinue levocarnitine treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering levocarnitine to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.

PRECAUTIONS

General

The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine and trimethylamine-N-oxide, since these metabolites are normally excreted in the urine.

Drug Interactions

Reports of INR increase with the use of warfarin have been observed. It is recommended that INR levels be monitored in patients on warfarin therapy after the initiation of treatment with levocarnitine or after dose adjustments.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Levocarnitine supplementation in nursing mothers has not been specifically studied.

Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.

ADVERSE REACTIONS

Clinical Trials Experience

Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis.

Postmarketing Experience

The following adverse reactions have been reported:

Neurologic Reactions: Seizures have been reported to occur in patients, with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.

Hypersensitivity reactions: Anaphylaxis, laryngeal edema, and bronchospasm.

For additional safety information, please see Full Prescribing Information.

You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch

or calling 1-800-FDA-1088.

REF 1593 11/2022

You are encouraged to report adverse drug events (ADEs) to American Regent:

T 1.800.734.9236;

E [email protected];

F 1.610.650.0170

ADEs may also be reported to the FDA:

1.800.FDA.1088

or www.fda.gov/medwatch

Medical Information:

T 1.888.354.4855

(9:00 am–5:00 pm Eastern Time, Monday–Friday)

www.americanregent.com/medical-affairs

For medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371

About American Regent

American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 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 is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose "to contribute to the enrichment of quality of life around the world." In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an "Innovative Global Healthcare Company Contributing to the Sustainable Development of Society."

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

All trademarks are the property of their respective owners.

Reference: 1. Orange book: Approved drug products with therapeutic equivalence evaluations. US Food & Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=075861#24057

Accessed April 27, 2023.

SOURCE American Regent Inc