Lucemyra (Lofexidine) Dosing and Treatment Protocol for Opioid Withdrawal
Recommended Dosage Regimen
The standard starting dose of Lucemyra is three 0.18 mg tablets (0.54 mg total) taken orally four times daily, with 5-6 hours between doses, for a total daily dose of 2.16 mg during the peak withdrawal period (typically days 1-7 after last opioid use). 1
Standard Dosing Parameters
- Maximum daily dose: 2.88 mg (16 tablets total per day) 1
- Maximum single dose: 0.72 mg (4 tablets) 1
- Dosing frequency: Four times daily with 5-6 hour intervals 1
- Treatment duration: Up to 14 days maximum, with dosing guided by withdrawal symptoms 1, 2
Peak Treatment Timing
- Lofexidine should be initiated during the period of peak withdrawal symptoms, which generally occurs during the first 5-7 days following last opioid use 1, 2
- The maximum dose should coincide with the most severe withdrawal symptoms, typically 5-7 days after opioid discontinuation 2
Dose Adjustments for Special Populations
Hepatic Impairment 1
- Mild impairment (Child-Pugh 5-6): 3 tablets four times daily (2.16 mg/day)
- Moderate impairment (Child-Pugh 7-9): 2 tablets four times daily (1.44 mg/day)
- Severe impairment (Child-Pugh >9): 1 tablet four times daily (0.72 mg/day)
Renal Impairment 1
- Moderate impairment (eGFR 30-89.9 mL/min/1.73 m²): 2 tablets four times daily (1.44 mg/day)
- Severe impairment, ESRD, or dialysis (eGFR <30): 1 tablet four times daily (0.72 mg/day)
- May be administered without regard to timing of dialysis 1
Treatment Discontinuation Protocol
Lofexidine must be discontinued with a gradual dose reduction over 2-4 days to prevent withdrawal symptoms from the medication itself. 1
- Reduce by 1 tablet per dose every 1-2 days 1
- Abrupt discontinuation can precipitate lofexidine withdrawal symptoms 1
Dose Modifications During Treatment
The dose should be reduced, held, or discontinued if patients demonstrate greater sensitivity to side effects, particularly hypotension, bradycardia, or syncope 1. Lower doses may be appropriate as opioid withdrawal symptoms wane 1.
Critical Monitoring Requirements
Vital Sign Monitoring 1
- Monitor blood pressure and pulse before each dose
- Assess for symptoms of hypotension, orthostasis, and bradycardia
- If clinically significant or symptomatic hypotension/bradycardia occurs, the next dose should be reduced, delayed, or skipped 1
Patient Education for Outpatient Use 1
- Patients must be capable of self-monitoring for hypotension, orthostasis, bradycardia, and associated symptoms
- Instruct patients to stay hydrated and recognize symptoms of low blood pressure
- Warn patients about increased risk when moving from supine to upright position 1
Place in Therapy: Critical Context
Lofexidine is significantly less effective than buprenorphine for managing opioid withdrawal and should be considered a second-line option. 3, 4, 5
Comparative Efficacy
- Buprenorphine demonstrates superior efficacy with lower average withdrawal scores (mean difference -0.43,95% CI -0.58 to -0.28) and higher treatment completion rates (RR 1.6,95% CI 1.2 to 2.1) compared to lofexidine 3
- For every 4 patients treated with buprenorphine instead of lofexidine, 1 additional person will complete treatment (NNT=4) 3
- Both lofexidine and clonidine show lower treatment completion rates compared to buprenorphine 4, 6
When to Use Lofexidine
Lofexidine is appropriate when: 4, 5
- Buprenorphine is contraindicated or unavailable
- Patient refuses opioid agonist therapy
- Lofexidine is preferred over clonidine in outpatient settings due to FDA approval specifically for opioid withdrawal and fewer hypotensive effects 4, 5
Administration Considerations
- Can be administered with or without food 1
- FDA-approved specifically for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults 1
- Has higher affinity and specificity for α2a receptors compared to clonidine, with less hypotension 2
Key Adverse Effects to Monitor 1, 2
- QT prolongation
- Hypotension and orthostatic hypotension
- Bradycardia
- Syncope