For: Opiate Withdrawal
Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal These highlights do not include all the information needed to use LUCEMYRA safely and effectively. See full prescribing information for LUCEMYRA.
LUCEMYRA� (lofexidine) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
LUCEMYRA is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. (1)
DOSAGE AND ADMINISTRATION
The usual LUCEMYRA dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals. LUCEMYRA treatment may be continued for up to 14 days with dosing guided by symptoms. (2.1)
Discontinue LUCEMYRA with a gradual dose reduction over 2 to 4 days. (2.1)
Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.18 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Risk of Hypotension, Bradycardia, and Syncope: May cause a decrease in blood pressure, a decrease in pulse, and syncope. Monitor vital signs before dosing and advise patients on how to minimize the risk of these cardiovascular effects and manage symptoms, should they occur. Monitor symptoms related to bradycardia and orthostasis. When using in outpatients, ensure that patients are capable of self-monitoring signs and symptoms. Avoid use in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal failure, as well as in patients with marked bradycardia. (5.1)
Risk of QT Prolongation: LUCEMYRA prolongs the QT interval. Avoid use in patients with congenital long QT syndrome. Monitor ECG in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias, hepatic or renal impairment, or in patients taking other medicinal products that lead to QT prolongation. (5.2)
Increased Risk of CNS Depression with Concomitant use of CNS Depressant Drugs: LUCEMYRA potentiates the CNS depressant effects of benzodiazepines and may potentiate the CNS depressant effects of alcohol, barbiturates, and other sedating drugs. (5.3)
Increased Risk of Opioid Overdose after Opioid Discontinuation: Patients who complete opioid discontinuation are at an increased risk of fatal overdose should they resume opioid use. Use in conjunction with a comprehensive management program for treatment of opioid use disorder and inform patients and caregivers of increased risk of overdose. (5.4)
Risk of Discontinuation Symptoms: Instruct patients not to discontinue therapy without consulting their healthcare provider. When discontinuing therapy, reduce dose gradually. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 10% and notably more frequent than placebo) are orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact US WorldMeds at 1-833-LUCEMYRA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Methadone: Methadone and LUCEMYRA both prolong the QT interval. ECG monitoring is recommended when used concomitantly. (7.1)
Oral Naltrexone: Concomitant use may reduce efficacy of oral naltrexone. (7.2)
CYP2D6 Inhibitors: Concomitant use of paroxetine resulted in increased plasma levels of LUCEMYRA. Monitor for symptoms of orthostasis and bradycardia with concomitant use of a CYP2D6 inhibitor. (7.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2018