LUCEMYRA (lofexidine)

LUCEMYRA (lofexidine) 

SELF ADMINISTRATION

Indications for Prior Authorization:

• Indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Patients must meet the following criteria for the indication above:

• Patient is 18 years of age and older, AND
• Diagnosis of opioid dependence or opioid use disorder, AND
• Prescribed by or in consultation with a specialist (e.g. pain management, addiction psychiatry, emergency medicine), AND
• Member is undergoing abrupt opioid discontinuation and chart notes document a medically appropriate reason why an opioid taper cannot be used, AND
• Patient has tried and failed Clonidine or experienced unacceptable toxicity and/or inadequate efficacy as confirmed by chart note documentation

Dosing:

• Starting dosage: 0.54mg (three 0.18mg tablets) four times daily during peak withdrawal symptoms (generally 5-7 days following last use of opioid)
• Max total daily dose: 2.88mg (16 tablets)
• Max 0.72mg (4 tablets) per dose
• Hepatic Impairment:
  • Mild Impairment: 3 tablets four times daily
  • Moderate Impairment: 2 tablets four times daily
  • Severe Impairment: 1 tablet four times daily
• Renal Impairment:
  • eGFR 30-89.9mL/min: 2 tablets four times daily
  • eGFR < 30mL/min: 1 tablet four times daily

Approval:

• Initial: 7 days
• Renewal: 7 days
• Total duration of therapy 14 days