What are the prescribing guidelines for Lucemyra (lofexidine) for opioid withdrawal?

Lucemyra (Lofexidine) Prescribing Guidelines for Opioid Withdrawal

Lucemyra (lofexidine) should be prescribed at a starting dose of three 0.18 mg tablets taken orally 4 times daily during peak withdrawal symptoms (typically first 5-7 days after last opioid use), with 5-6 hours between doses, and continued for up to 14 days based on symptom severity. 1

Dosing Protocol

• Standard dosing:

  • Initial dose: 0.54 mg (three 0.18 mg tablets) 4 times daily
  • Maximum daily dose: 2.88 mg (16 tablets total)
  • Maximum single dose: 0.72 mg (4 tablets)
  • Dosing interval: 5-6 hours between doses 1
  • Treatment duration: Up to 14 days, guided by withdrawal symptoms

• Dose adjustments:

  • Reduce dose for patients with greater sensitivity to side effects
  • Lower doses may be appropriate as withdrawal symptoms wane
  • Can be administered with or without food 1

Discontinuation Protocol

• Taper gradually over 2-4 days to prevent lofexidine withdrawal symptoms
• Recommended tapering: Reduce by 1 tablet per dose every 1-2 days 1
• Do not discontinue abruptly

Special Populations

Hepatic Impairment 1

• Mild impairment (Child-Pugh 5-6): 3 tablets 4 times daily (2.16 mg/day)
• Moderate impairment (Child-Pugh 7-9): 2 tablets 4 times daily (1.44 mg/day)
• Severe impairment (Child-Pugh >9): 1 tablet 4 times daily (0.72 mg/day)

Renal Impairment 1

• Moderate impairment (GFR 30-89.9 mL/min/1.73m²): 2 tablets 4 times daily (1.44 mg/day)
• Severe impairment/ESRD/dialysis (GFR <30): 1 tablet 4 times daily (0.72 mg/day)
• Can be administered without regard to dialysis timing

Monitoring Requirements

• Monitor vital signs before dosing
• Assess for symptoms related to bradycardia and orthostasis
• Patients in outpatient settings must be capable of self-monitoring for hypotension, orthostasis, bradycardia, and associated symptoms 1
• If clinically significant hypotension or bradycardia occurs, reduce, delay, or skip the next dose

Safety Considerations

Major Adverse Effects

• QT prolongation
• Hypotension
• Orthostasis
• Bradycardia 2

Patient Education

• Instruct patients to stay hydrated
• Teach patients to recognize symptoms of low blood pressure
• Inform patients about increased risk when moving from supine to upright position 1
• Explain that lofexidine does not treat the underlying opioid use disorder

Clinical Context

• Lofexidine is indicated specifically for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults 1
• It decreases sympathetic outflow that causes withdrawal symptoms by acting as an α2-adrenergic agonist 2
• Unlike methadone or buprenorphine, lofexidine does not reinforce opioid dependence 2
• Clinical trials have demonstrated lofexidine's efficacy in reducing withdrawal symptoms compared to placebo 3

Alternative Approaches

• For patients with opioid use disorder requiring longer-term treatment, consider medication-assisted treatment (MAT) with buprenorphine/naloxone or methadone 4
• For patients with severe withdrawal symptoms unresponsive to lofexidine, consider referral to specialized addiction treatment programs 4

Common Pitfalls to Avoid

1. Abrupt discontinuation: Always taper lofexidine to prevent withdrawal symptoms from the medication itself
2. Inadequate monitoring: Failure to monitor for cardiovascular side effects, especially in outpatient settings
3. Exceeding maximum dose: Never exceed 2.88 mg daily or 0.72 mg per single dose
4. Prolonged treatment: Lofexidine is only approved for up to 14 days of treatment
5. Ignoring contraindications: Use caution in patients on beta-blockers or ACE inhibitors 5

Remember that lofexidine treats withdrawal symptoms but is not a treatment for opioid use disorder itself. Appropriate referrals for comprehensive addiction treatment should be provided.