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.
"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.
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.
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.
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.
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.
