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Carnitine deficiency is a potentially serious metabolic disorder

Carnitine deficiency may interfere with normal metabolism and can cause potentially serious health problems.1
LEARN MORE ABOUT CARNITINE DEFICIENCY

There are two major forms of carnitine deficiency, primary and secondary carnitine deficiency.

Primary carnitine deficiency in newborns is diagnosed in 1 in 142,000 births in the United States each year.4

Primary carnitine deficiency is a rare inherited autosomal recessive genetic condition caused by mutations in the SLC22A5 gene.2

Screening newborns for carnitine deficiency

can detect low levels before symptoms emerge.3

Secondary carnitine deficiency in patients undergoing hemodialysis has multiple causes.

Secondary carnitine deficiency occurs in all patients undergoing hemodialysis for end-stage renal disease (ESRD) and other forms of kidney failure for several reasons:6

Hemodialysis: From the very first session, hemodialysis removes carnitine from the blood.

Reduced Intake: Inadequate intake via diet can exacerbate the decrease in carnitine.

Reduced production: The human body synthesizes 25 percent of its carnitine requirement, endogenously in the kidneys and liver. Patients on hemodialysis may have reduced production.

Total carnitine levels have been reported to decrease as much as 70 percent with a single hemodialysis treatment.6

All patients undergoing chronic dialysis will develop carnitine deficiency.6

ESRD patients with low carnitine can be identified with a simple carnitine blood test.4

Other causes of secondary carnitine deficiency include:4,5

Mitochondrial disease, certain inborn errors of metabolism that result in accumulation of toxic organic acids.

Liver disease

Certain medications, including valproic acid, cyclosporine, pivampicillin, and some anti-cancer drugs (such as etoposide and vinblastine).

Severe malabsorptive states

Malnutrition

Recognize carnitine deficiency when you see it.

Knowing the signs and symptoms of carnitine deficiency is the first step to making a diagnosis. Carnitine deficiency may cause the following2,7:

  • encephalopathy
  • cardiomyopathy
  • hypoglycemia
  • myopathy
  • vomiting
  • erythropoietin-resistant anemia
  • intradialytic hypotension
Is your ESRD patient possibly experiencing carnitine deficiency associated with hemodialysis?
LEARN MORE

CARNITOR® will correct carnitine deficiency. If you suspect your patient is carnitine deficient, click on the link below to learn more about testing.

LEARN MORE
Sources
  1. Carnitine: Fact Sheet for Health Professionals. National Institutes of Health. Updated April 17, 2023. Accessed September 20, 2023. https://ods.od.nih.gov/factsheets/Carnitine-HealthProfessional/.
  2. Primary Carnitine Deficiency: MedlinePlus Genetics. MedlinePlus. November 27, 2023. Accessed September 20, 2023. https://medlineplus.gov/genetics/condition/primary-carnitine-deficiency/.
  3.  Primary Carnitine Deficiency. Health Resources & Services Administration. Updated December, 2023. Accessed September 20, 2023. https://newbornscreening.hrsa.gov/conditions/primary-carnitine-deficiency.
  4. Dahash BA. Carnitine Deficiency. StatPearls [Internet]. Updated August 7, 2023. Accessed March 20, 2023. https://www.ncbi.nlm.nih.gov/books/NBK559041/.
  5. CARNITOR® (levocarnitine) Injection [package insert]. Rockville, MD. Leadiant Biosciences, Inc. April, 2018.
  6. Evans AM, Faull RJ, Nation RL, et al. Impact of hemodialysis on endogenous plasma and muscle carnitine levels in patients with end-stage renal disease. Kidney International. 2004;66(4):1527-1534. doi:10.1111/j.1523-1755.2004.00916.x
  7.  Eknoyan G, Latos DL, Lindberg J. Practice Recommendations for the Use of L-Carnitine in Dialysis-Related Carnitine Disorder. National Kidney Foundation. Carnitine Consensus Conference. American Journal of Kidney Diseases. 2003;41(4):868-876. doi:10.1016/s0272-6386(03)00110-0

INDICATIONS AND IMPORTANT SAFETY INFORMATION 

Indications  
CARNITOR® (levocarnitine) Tablets, Oral Solution, and Sugar-Free Oral Solution are indicated for the treatment of primary systemic carnitine deficiency.
CARNITOR® (levocarnitine) Injection is indicated for the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
CARNITOR® (levocarnitine) Injection, Tablets, Oral Solution, and Sugar-Free Oral Solution are also indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.

IMPORTANT SAFETY INFORMATION 

Contraindications

None known.

Warnings

Carnitor®(levocarnitine) Tablets, Oral Solution, and Sugar-Free Oral Solution

Hypersensitivity Reactions

Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral CARNITOR®. Other serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following intravenous levocarnitine administration, mostly in patients with end stage renal disease undergoing dialysis.

Discontinue use of CARNITOR® and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

Carnitor® (levocarnitine) Injection

Hypersensitivity Reactions

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

If a severe hypersensitivity reaction occurs, discontinue CARNITOR® treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering CARNITOR® 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 (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine.

Carnitor® (levocarnitine) Tablets, Oral Solution, and Sugar-Free Oral Solution

CARNITOR® (levocarnitine) Oral Solution and CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only.  Not for parenteral use

Gastrointestinal reactions may result from a too rapid consumption of carnitine. CARNITOR® (levocarnitine) Oral Solution and CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution may be consumed alone, or dissolved in drinks or other liquid foods to reduce taste fatigue. They should be consumed slowly and doses should be spaced evenly throughout the day to maximize tolerance.

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.

Adverse Reactions

The following adverse reactions associated with the use of levocarnitine were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliability, or to establish a causal relationship to drug exposure.

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.

Carnitor® (levocarnitine) Tablets, Oral Solution, and Sugar-Free Oral Solution

Gastrointestinal Reactions: Various mild gastrointestinal complaints have been reported during the long-term administration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea. Gastrointestinal adverse reactions with CARNITOR® (levocarnitine) Oral Solution or CARNITOR® SF (levocarnitine) Sugar-Free Oral Solution dissolved in liquids might be avoided by a slow consumption of the solution or by a greater dilution. Decreasing the dosage often diminishes or eliminates drug-related patient body odor or gastrointestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration, and after any dosage increases.

Musculoskeletal Reactions: Mild myasthenia has been described only in uremic patients receiving D,L-carnitine.

Hypersensitivity Reactions: Rash, urticaria, and facial edema have been reported with oral CARNITOR® (see WARNINGS).

Carnitor® (levocarnitine) Injection

Gastrointestinal Reactions: Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology.

Hypersensitivity reactions: Anaphylaxis, laryngeal edema and bronchospasm (see WARNINGS).

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

The risk information provided here is not comprehensive. Refer to the full FDA-approved product labeling.

© 2024, Leadiant Biosciences, Inc.

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