LUCEMYRA Safety Profile1

Adverse reactions reported by ≥10% of LUCEMYRA-treated patients and more frequently than placebo in the 7-day study

Adverse reaction data for LUCEMYRA
  • 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. Elevations in blood pressure above normal values (≥ 140 mmHg systolic) and above a subject’s pre-treatment baseline are associated with discontinuing LUCEMYRA, and peaked on the second day after discontinuation. Blood pressure values were evaluated for 3 days following the last dose of a 5-day course of LUCEMYRA 2.88 mg/day.

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

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

Reference:

  1. LUCEMYRA™ (lofexidine) [Prescribing Information]. Louisville, KY: US WorldMeds, LLC; 2018.