Test Catalog

Test Id : DULOX

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Duloxetine, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring duloxetine serum concentration during therapy

 

Evaluating potential duloxetine toxicity

 

Evaluating patient compliance

Method Name
A short description of the method used to perform the test

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Duloxetine, S

Aliases
Lists additional common names for a test, as an aid in searching

Ariclaim

Cymbalta (Duloxetine)

Duloxetine (Cymbalta)

Xeristar

Yentreve

Specimen Type
Describes the specimen type validated for testing

Serum Red

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood immediately before the next scheduled dose (trough).

2. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
 

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring duloxetine serum concentration during therapy

 

Evaluating potential duloxetine toxicity

 

Evaluating patient compliance

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Duloxetine is an antidepressant of the serotonin-norepinephrine reuptake inhibitor class. It is effective in treating symptoms of depression, including physical pain associated with depression; other uses include therapy of neuropathic pain, fibromyalgia, and urinary stress incontinence. Duloxetine also inhibits serotonin uptake in human platelets and may be associated with potentiation of bleeding.

 

Duloxetine undergoes extensive hepatic biotransformation to numerous inactive metabolites. The drug is metabolized by cytochrome P450 (CYP) 1A2 and CYP2D6, with moderate potential for drug interactions (duloxetine is both a substrate and a moderate inhibitor of CYP2D6). The mean elimination half-life is 12.5 hours with steady-state concentrations occurring in about 3 days. Specimens for therapeutic monitoring should be collected immediately before the next scheduled dose (ie, trough).

 

Duloxetine is not recommended for patients with hepatic impairment, substantial alcohol use, or chronic liver disease. Use in patients with kidney disease significantly increases exposure to duloxetine due to decreased elimination. Patients with mild-to-moderate kidney dysfunction should be monitored closely; use of duloxetine is not recommended for patients with kidney failure.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

30-120 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Therapeutic ranges are not well-established, but literature suggests that patients receiving duloxetine monotherapy for depression responded well when trough concentrations were 30 to 120 ng/mL. Higher levels may be tolerated by individual patients. The therapeutic relevance of this concentration range to other uses of duloxetine therapy is currently unknown.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Specimens obtained using gel tube or anticoagulant collections cause assay interference.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51(1-02):9-62

2. Westanmo AD, Gayken J, Haight R. Duloxetine: a balanced and selective norepinephrine- and serotonin-reuptake inhibitor. Am J Health-Syst Pharm. 2005;62(23):2481-2490

3. Waldschmitt C, Vogel F, Pfuhlmann B, Hiemke C. Duloxetine serum concentrations and clinical effects. Data from a therapeutic drug monitoring (TDM) survey. Pharmacopsychiatry. 2009;42(5):189-193

4. Feighner JP, Cohn JB. Double-blind comparative trials of fluoxetine and doxepin in geriatric patients with major depressive disorder. J Clin Psychiatry. 1985;46(3 Pt 2):20-25

5. Kelly MW, Perry PJ, Holstad SG, Garvey MJ. Serum fluoxetine and norfluoxetine concentrations and antidepressant response. Ther Drug Monit. 1989;11:165-170

6. Benfield P, Heel RC, Lewis SP. Fluoxetine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depressive illness. Drugs. 1986;32(6):481-508

7. Wille SM, Cooreman SG, Neels, et al. Relevant issues in the monitoring and toxicology of antidepressants. Crit Rev Clin Lab Sci. 2008;45(1):25-89

Method Description
Describes how the test is performed and provides a method-specific reference

Serum samples containing duloxetine are diluted in an aqueous solution containing deuterated internal standard and then injected onto a high-turbulence liquid chromatography system for online extraction. Detection is by tandem mass spectrometry.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Wednesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 8 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
DULOX Duloxetine, S 46227-5
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
89305 Duloxetine, S 46227-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports