LUCEMYRA® Safety Profile1

Adverse reactions reported by ≥10% of LUCEMYRA-treated patients and more frequently than placebo1

Adverse reactions reported by ≥10% of patients receiving LUCEMYRA 2.88 mg* (N=222) included insomnia (55%), orthostatic hypotension (42%), bradycardia (32%), hypotension (30%), dizziness (23%), somnolence (13%), sedation (12%), and dry mouth (11%)

*Assigned dose; mean average daily dose received was 79% of assigned dose due to dose-holds for out-of-range vital signs

LUCEMYRA may lead to hypotension, bradycardia, or syncope1

  • If clinically significant or symptomatic hypotension and/or bradycardia occur, the next dose of LUCEMYRA should be reduced in amount, delayed, or skipped
  • Syncope occurred in less than 3% of patients receiving LUCEMYRA compared to 0% of patients receiving placebo

Avoid using LUCEMYRA in certain patient populations, including1:

  • Patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or chronic renal failure, and in patients with marked bradycardia
  • Patients taking any medications that decrease pulse or blood pressure to avoid the risk of excessive bradycardia and hypotension

LUCEMYRA prolongs the QT interval in patients withdrawing from opioids1

  • Avoid using LUCEMYRA in patients with congenital long QT syndrome
  • Monitor ECG in patients with congestive heart failure, bradyarrhythmias, hepatic impairment, renal impairment, or patients taking other medicinal products that lead to QT prolongation

There are no contraindications associated with LUCEMYRA1

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Reference:

  1. LUCEMYRA® (lofexidine) [Prescribing Information]. USWM, LLC; 2020.