Levocarnitine (injection)

Levocarnitine (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Dosage

Metabolic Disorders The recommended dose is 50 mg/kg given as a slow 2-3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours. It should be administered q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg.

It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 µmol/L) and overall clinical condition.

ESRD Patients on Hemodialysis The recommended starting dose is 10-20 mg/kg dry body weight as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40-50 µmol/L). Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levocarnitine (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levocarnitine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Levocarnitine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Levocarnitine (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Levocarnitine (injection) in pediatric patients.

Contraindications

None known.

Warnings

None.

Precautions

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.

Adverse Reactions

Clinical Trials Experience

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.

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.

The table below lists the adverse events that have been reported in two double-blind, placebo-controlled trials in patients on chronic hemodialysis. Events occurring at ≥5% are reported without regard to causality.

Adverse Events with a Frequency ≥5% Regardless of Causality by Body System

Postmarketing Experience

There is limited information regarding Levocarnitine (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Levocarnitine (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to CARNITOR®. There are, however, no adequate and well controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Levocarnitine (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Levocarnitine (injection) during labor and delivery.

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.

Pediatric Use

See Dosage and Administration.

Geriatic Use

There is no FDA guidance on the use of Levocarnitine (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Levocarnitine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Levocarnitine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Levocarnitine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Levocarnitine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Levocarnitine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Levocarnitine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Levocarnitine (injection) Administration in the drug label.

Monitoring

There is limited information regarding Levocarnitine (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Levocarnitine (injection) and IV administrations.

Overdosage

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD50 of levocarnitine in rats is 5.4 g/kg and the oral LD50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

Pharmacology

There is limited information regarding Levocarnitine (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Levocarnitine (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Levocarnitine (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Levocarnitine (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Levocarnitine (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic. No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine.

Clinical Studies

There is limited information regarding Levocarnitine (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Levocarnitine (injection) How Supplied in the drug label.

Storage

There is limited information regarding Levocarnitine (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Levocarnitine (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Levocarnitine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Levocarnitine (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Levocarnitine (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.