Lucemyra Side Effects Center

Last updated on RxList: 3/10/2022
Lucemyra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lucemyra?

Lucemyra (lofexidine) is a central alpha-2 adrenergic agonist indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

What Are Side Effects of Lucemyra?

Common side effects of Lucemyra include:

Dosage for Lucemyra/h4>

The usual Lucemyra dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals Lucemyra treatment may be continued for up to 14 days with dosing guided by symptoms.

What Drugs, Substances, or Supplements Interact with Lucemyra?

Lucemyra may interact with methadone, oral naltrexone, other drugs that can make you sleepy (benzodiazepines, alcohol, barbiturates, and other sedating drugs), and paroxetine. Tell your doctor all medications and supplements you use.

Lucemyra During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Lucemyra; it may harm a fetus. It is unknown if Lucemyra passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Lucemyra (lofexidine) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Lucemyra Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow heartbeats;
  • severe dizziness or drowsiness; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • low blood pressure;
  • dizziness (especially when standing up);
  • drowsiness; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lucemyra (Lofexidine Tablets, for Oral Use)

Lucemyra Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

  • Hypotension, Bradycardia, and Syncope [see WARNINGS AND PRECAUTIONS]
  • QT Prolongation [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System Depression [see WARNINGS AND PRECAUTIONS]
  • Opioid Overdose [see WARNINGS AND PRECAUTIONS]
  • Discontinuation Symptoms [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to adverse reaction rates observed for another drug and may not reflect the rates observed in practice.

The safety of LUCEMYRA was supported by three randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine, or naltrexone.

The three randomized, double-blind, placebo-controlled clinical trials enrolled 935 subjects dependent on short-acting opioids undergoing abrupt opioid withdrawal. Patients were monitored before each dose in an inpatient setting.

Table 3 presents the incidence, rounded to the nearest percent, of adverse events that occurred in at least 10% of subjects treated with LUCEMYRA and for which the incidence in patients treated with LUCEMYRA was greater than the incidence in subjects treated with placebo in a study that tested two doses of LUCEMYRA, 2.16 mg per day and 2.88 mg per day, and placebo. The overall safety profile in the combined dataset was similar.

Orthostatic hypotension, bradycardia, hypotension, dizziness, somnolence, sedation, and dry mouth were notably more common in subjects treated with LUCEMYRA than subjects treated with placebo.

Table 3: Adverse Reactions Reported by ≥10% of LUCEMYRA-Treated Patients and More Frequently than Placebo

Adverse Reaction LUCEMYRA 2.16 mg*
(%)
N=229
LUCEMYRA 2.88 mg*
(%)
N=222
Placebo (%)
N=151
Insomnia 51 55 48
Orthostatic Hypotension 29 42 5
Bradycardia 24 32 5
Hypotension 30 30 1
Dizziness 19 23 3
Somnolence 11 13 5
Sedation 13 12 5
Dry Mouth 10 11 0
* Assigned dose; mean average daily dose received was 79% of assigned dose due to dose-holds for out-of-range vital signs.

Other notable adverse reactions associated with the use of LUCEMYRA but reported in <10% of patients in the LUCEMYRA group included:

  • Syncope: 0.9%, 1.4% and 0% for LUCEMYRA 2.16 mg/day and 2.88 mg/day and placebo, respectively
  • Tinnitus: 0.9%, 3.2% and 0% for LUCEMYRA 2.16 mg/day and 2.88 mg/day and placebo, respectively
Blood Pressure Changes And Adverse Reactions After LUCEMYRA Cessation

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, as shown in Table 4. Blood pressure values were evaluated for 3 days following the last dose of a 5-day course of LUCEMYRA 2.88 mg/day.

Table 4: Blood Pressure Elevations after Stopping Treatment

  Abrupt LUCEMYRA
Discontinuation
2.88 mg
(N = 134)
Placebo
(N = 129)
N at risk n (%) N at risk n (%)
Systolic Blood Pressure on Day 2 after Discontinuation    
≥ 140 mmHg and ≥ 20 mmHg increase from baseline 58 23 (39.7) 37 6 (16.2)
≥ 170 mmHg and ≥ 20 mmHg increase from baseline 58 5 (8.6) 37 0

Blood pressure elevations of a similar magnitude and incidence were observed in a small number of patients (N=10) that had a one-day, 50% dose reduction prior to discontinuation.

After stopping treatment, subjects that were taking LUCEMYRA also had a higher incidence of diarrhea, insomnia, anxiety, chills, hyperhidrosis, and extremity pain compared to subjects who were taking placebo.

Sex-Specific Adverse Event Findings

Four out of 101 females (4%) had serious cardiovascular adverse events compared to 3 out of 289 (1%) of males assigned to receive LUCEMYRA 2.88 mg per day.

Discontinuations and dose holds due to bradycardia and orthostatic hypotension, which are the most common adverse reactions associated with LUCEMYRA, occurred with a greater incidence in females assigned to receive the highest studied dose of LUCEMYRA, 2.88 mg per day as shown in Table 5.

Table 5: Discontinuations and Dose Holds for Bradycardia and Orthostatic Hypotension by LUCEMYRA Dose and Sex

  LUCEMYRA 2.16 mg LUCEMYRA 2.88 mg
Male 22/162 (14%) 29/158 (18%)
Female 9/67 (13%) 20/64 (31%)

Postmarketing Experience

Lofexidine is marketed in other countries for relief of opioid withdrawal symptoms. The following events have been identified during postmarketing use of lofexidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Since lofexidine's initial market introduction in 1992, the most frequently reported postmarketing adverse event with lofexidine has been hypotension [see WARNINGS AND PRECAUTIONS]. There has been one report of QT prolongation, bradycardia, torsades de pointes, and cardiac arrest with successful resuscitation in a patient that received lofexidine and three reports of clinically significant QT prolongation in subjects concurrently receiving methadone with lofexidine.

DRUG INTERACTIONS

Methadone

LUCEMYRA and methadone both prolong the QT interval. ECG monitoring is recommended in patients receiving methadone and LUCEMYRA [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Oral Naltrexone

Coadministration of LUCEMYRA and oral naltrexone resulted in statistically significant differences in the steady-state pharmacokinetics of naltrexone. It is possible that oral naltrexone efficacy may be reduced if used concomitantly within 2 hours of LUCEMYRA. This interaction is not expected if naltrexone is administered by non-oral routes [see CLINICAL PHARMACOLOGY].

CNS Depressant Drugs

LUCEMYRA potentiates the CNS depressant effects of benzodiazepines and may potentiate the CNS depressant effects of alcohol, barbiturates, and other sedating drugs. Advise patients to inform their healthcare provider of other medications they are taking, including alcohol [see WARNINGS AND PRECAUTIONS].

CYP2D6 Inhibitor

Paroxetine

Coadministration of LUCEMYRA and paroxetine resulted in 28% increase in the extent of absorption of LUCEMYRA. Monitor for orthostatic hypotension and bradycardia when an inhibitor of CYP2D6 is used concomitantly with LUCEMYRA [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Lucemyra (Lofexidine Tablets, for Oral Use)

© Lucemyra Patient Information is supplied by Cerner Multum, Inc. and Lucemyra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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