STEPS

New Drug Reviews

Lofexidine (Lucemyra) for Treatment of Opioid Withdrawal Symptoms

 

Am Fam Physician. 2019 Mar 15;99(6):392-394.

Lofexidine (Lucemyra) is an alpha-adrenergic agonist and a structural analogue of clonidine. Lofexidine is labeled for use in the mitigation of withdrawal symptoms for up to 14 days during abrupt discontinuation of opioids in adults.1

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DrugDosageDose formCost*

Lofexidine (Lucemyra)

Three 0.18-mg tablets taken four times daily, followed by gradual tapering

0.18-mg oral tablet

$1,776 for 84 tablets (initial seven days)


*—Estimated retail price of initial seven days of treatment (before tapering) based on information obtained at https://www.goodrx.com (accessed January 22, 2019).

DrugDosageDose formCost*

Lofexidine (Lucemyra)

Three 0.18-mg tablets taken four times daily, followed by gradual tapering

0.18-mg oral tablet

$1,776 for 84 tablets (initial seven days)


*—Estimated retail price of initial seven days of treatment (before tapering) based on information obtained at https://www.goodrx.com (accessed January 22, 2019).

Safety

Serious adverse effects of lofexidine are relatively rare and have been shown to be dose related. No adverse effects were reported by a group of 229 patients treated with 2.4 mg of lofexidine per day.2 At the higher dosage of 3.2 mg per day, serious adverse effects included suicidal ideation (0.5%), bradycardia (0.8%), and hypotension or syncope (1.1%). Lofexidine should not be prescribed for children or adolescents, pregnant or nursing women, or for patients older than 65 because it has not been studied in these groups. It should not be used in patients with severe coronary insufficiency, recent myocardial infarction, stroke, renal failure, or significant bradycardia. Central nervous system depression is a serious risk, especially if lofexidine is taken in combination with benzodiazepines, alcohol, barbiturates, or other sedating drugs. Lofexidine should only be prescribed within a program of close medical supervision. Maximal doses of lofexidine may prolong the QT interval by an additional 10 milliseconds. This should be closely monitored in high-risk patients, such as those with a baseline QT interval greater than 450 milliseconds, or those with concomitant methadone use.1 Lofexidine is not an opioid and does not affect psychological cravings. Patients should transition to a long-term treatment plan for opioid use disorder.

Tolerability

Lofexidine is a centrally-acting sympatholytic and has been shown to cause dose-related hypotension averaging about 10 mm Hg, although this is typically not clinically significant. At a daily dosage of

Address correspondence to Carl Bryce, MD, at carl.bryce.mil@mail.mil. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.


The views expressed are those of the author and do not reflect the official policy or position of the U.S. Air Force, the Department of Defense, or the U.S. government.

References

show all references

1. DailyMed. Drug label information: LUCEMYRA—lofexidine hydrochloride tablet, film coated. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=bdcfe803-b556-47db-a54f-ae0f0e5be016&type=display. Accessed January 1, 2019....

2. Advisory Committee. Lofexidine Hydrochloride (Lucemyra) Briefing Document. NDA #209229. March 27, 2018. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM602419.pdf. Accessed January 16, 2019.

3. Gowing L, Farrell M, Ali R, White JM. Alpha2-adrenergic agonists for the management of opioid withdrawal. Cochrane Database Syst Rev. 2016;(5):CD002024.

4. Gowing L, Ali R, White JM, Mbewe D. Buprenorphine for managing opioid withdrawal. Cochrane Database Syst Rev. 2017;(2):CD002025.

5. Royall M, Garner KK, Hill SR, Barnes M. Alpha-adrenergic agonists for the management of opioid withdrawal. Am Fam Physician. 2017;95(1):Online.

6. Kowalczyk WJ, Phillips KA, Jobes ML, et al. Clonidine maintenance prolongs opioid abstinence and decouples stress from craving in daily life: a randomized controlled trial with ecological momentary assessment. Am J Psychiatry. 2015;172(8):760–767.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Assistant Medical Editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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