LUCEMYRA® Videos

Hear from an HCP and patients about their experiences with LUCEMYRA

HCP Experience

Dr. Said discusses helping his patient with physical opioid dependence

Dr. Said talks about helping his patient with Opioid Use Disorder (OUD)

Real Patient Experiences

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Opioid Withdrawal Management: Patient Case Profiles

The following seven patient profiles represent patients who may be appropriate for treatment with LUCEMYRA. These include four patients with physical opioid dependence and three patients with Opioid Use Disorder (OUD)

Successful Opioid Withdrawal Syndrome (OWS) management can help both physically dependent and OUD patients through opioid withdrawal
When treating patients with OUD, LUCEMYRA should only be used in conjunction with a comprehensive management program for the treatment of Opioid Use Disorder

Physical Opioid Dependence

Kaitlyn J.*

50 years old

Physical Opioid Dependence (Pre Procedure)

Medical History

Medical history is significant for degenerative disc disease in the lower spine, which was diagnosed two years ago by an osteopathic physician.

Over the past two years, the patient and physician tried a variety of therapies for pain relief, including ibuprofen, as well as physical therapy.

A year ago, the patient began to receive epidural corticosteroid injections every 90 days due to increasing pain.

Opioid Use

Over the past year, the patient was additionally prescribed oxycodone for pain and is currently taking oxycodone 160 mg PO (240 morphine milligram equivalents [MME]/day).¹ The patient was advised to continue her routine physical therapy and epidural injections.

One month ago, the patient reported to her physician that her pain and physical function were not improving. She was referred to an orthopedic spine surgeon. The surgeon recommended implanting an intrathecal morphine pump due to the nature and severity of the pain.

Concerned about the post-operative recovery outcome, the surgeon advised the patient and her physician that the patient would need to discontinue oxycodone before the surgery.

Due to the patient’s increasing dysfunction, both the patient and her physician agreed to discontinue oxycodone and initiate LUCEMYRA^® (lofexidine) for withdrawal symptom relief one week prior to surgical implantation.

Opioid Discontinuation Treatment Plan

Oxycodone was tapered over a 10-day period by decreasing the dosage each day, with the goal to reduce daily oxycodone intake by approximately 10 mg/day (15 MME/day) to reach 60 mg oxycodone daily (90 MME/day) on Day 10. Starting on Day 11, the patient stopped taking oxycodone.
At opioid discontinuation (starting on Day 11), the patient began taking LUCEMYRA to help mitigate her withdrawal symptoms. LUCEMYRA was taken as follows:
- For the first 7 days, the patient took three 0.18 mg LUCEMYRA tablets (0.54 mg) orally four times each day
- On Day 8, the patient took two 0.18 mg LUCEMYRA tablets (0.36 mg) orally four times
- For the final (9th) day of treatment, the patient took one 0.18 mg LUCEMYRA tablet orally four times
Throughout the week, the patient and physician kept in frequent contact to monitor her withdrawal symptoms and adjust the dose of LUCEMYRA, as needed
The patient subsequently underwent implantation of an intrathecal morphine pump without complication

Results/Follow-up

The pump was successfully implanted, and the patient has since responded well.

The patient was discharged from the hospital after 3 days and has only reported minor, residual pain that has been manageable without the need for additional oral pain medication.

Daniel T.*

28 years old

Physical Opioid Dependence (Post Surgery)

Medical History

Surgical history significant for surgery on left forearm, during which time internal fixation was utilized to repair multiple fractures to both the radius and ulna.

Opioid Use

The patient was initially prescribed hydrocodone bitartrate (5 mg)/acetaminophen (325 mg) by his surgeon every 4 to 6 hours (as needed) for post-surgical pain relief. The patient was then referred to his PCP two weeks later for a post-operative follow-up.

During the first post-operative visit, the PCP created a treatment plan with the patient. They both agreed that the patient should be maintained on hydrocodone/acetaminophen for as long as severe pain was expected to last, typically around 60 days.

Since the patient agreed to discontinue opioids once his severe pain subsided, the PCP proactively discussed introducing LUCEMYRA® (lofexidine) as part of their opioid exit strategy.

Diagnosis

At the 60-day follow-up appointment, the PCP and patient both agreed that opioids were no longer needed for pain relief and would be discontinued.

However, the PCP explained to the patient that he had likely developed physical opioid dependence over the previous two months and could be at risk for experiencing opioid withdrawal. As planned, the PCP prescribed the patient LUCEMYRA to help relieve withdrawal symptoms.

Opioid Discontinuation Treatment Plan

The PCP and patient both agreed that the patient would continue opioid therapy for 3 additional days before receiving LUCEMYRA
Patient began taking LUCEMYRA at the first sign of withdrawal symptoms (three 0.18 mg tablets [0.54 mg] taken orally four times daily) and continued therapy for the recommended 9 days
- For the first 7 days, the patient took three 0.18 mg LUCEMYRA tablets (0.54 mg) orally four times each day
- On Day 8, the patient took two 0.18 mg LUCEMYRA tablets (0.36 mg) orally four times
- On Day 9, the final day of treatment, the patient took one 0.18 mg LUCEMYRA tablet orally four times

Results/Follow-up

Patient was able to complete a 9-day treatment plan with symptom relief provided by LUCEMYRA.

He has since reported minimal pain that is being managed as needed with over-the-counter NSAIDs, such as ALEVE®.

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Leonard D.*

25 years old

Physical Opioid Dependence

Medical History

Surgical history is significant for two surgeries on left knee to repair anterior cruciate ligament tears and a torn meniscus.

Current medications include hydrocodone and acetaminophen.

Patient is employed full-time as a landscaper and plays basketball in a local league.

Opioid Use

After the patient underwent his second knee surgery, hydrocodone bitartrate (5 mg)/acetaminophen (325 mg) was prescribed by surgeon as needed every 4 to 6 hours for post-surgical pain relief. The patient was referred to his PCP for follow-up one week later.

Based on persistent pain, patient’s analgesic was changed to oxycodone. Subsequent re-evaluations resulted in the patient taking oxycodone 10 mg immediate release PO every 4 to 6 hours for three months.

Diagnosis

At his next visit, patient complained about reduced pain relief and asked for dosage increase. During consultation, the patient admitted not taking the medication as prescribed. Probed about symptoms, patient mentioned perspiring, cold flashes, nausea, vomiting, and muscle cramps, which caused missed work days and prevented him from playing basketball.

These symptoms were consistent with Opioid Withdrawal Syndrome (OWS) and a diagnosis of physical opioid dependence.

This diagnosis was discussed with patient as well as the potential risk for progression to Opioid Use Disorder (OUD). Patient agreed to discontinue oxycodone and complete the process of opioid withdrawal.

Opioid Discontinuation Treatment Plan

Patient deemed appropriate for withdrawal management at home
Prescribed naproxen for analgesia and LUCEMYRA® (lofexidine) for mitigation of withdrawal symptoms to facilitate abrupt opioid discontinuation
Patient to immediately discontinue oxycodone and start 7-day course of LUCEMYRA (three tabs 4 times a day for 5 days) with 2-day taper (two tabs 4 times a day, then one tab 4 times a day)
Patient advised to take other supportive medications as needed for additional symptom relief

Results/Follow-up

Patient was able to complete 7-day treatment plan with symptom relief provided by LUCEMYRA.

Patient has remained off oxycodone and has resumed working full time and playing basketball.

Patient also scheduled a follow-up appointment with his PCP to discuss the potential need for additional treatment.

Tracey A.*

48 years old

Physical Opioid Dependence

Medical History

Medical history is significant for lumbar disc disease due to trauma, dysthymia, and anxiety.

Current medications include duloxetine, alprazolam^†, and oxycodone.

Patient is a high school teacher and a guidance counselor.

Opioid Use

Patient was prescribed oxycodone for persistent lower back pain before referral to current healthcare provider. Refills requested at routine office visits.

After six months, tapering of opioid dosage was discussed, but patient said she needed to take full dose to manage the ongoing pain.

Diagnosis

Patient reported increased back pain and bouts of chills/nausea, causing her to miss work. Updated diagnostic imaging was ordered and showed no worsening of her lumbar disc disease.

Patient admitted to trying to reduce oxycodone dosage on her own and was diagnosed with physical opioid dependence.

Her increased pain was determined to be symptoms of opioid-induced hyperalgesia and the chills and nausea were symptoms of Opioid Withdrawal Syndrome (OWS), caused by attempted opioid dosage reduction.

Opioid Discontinuation Treatment Plan

Opioid discontinuation was discussed and patient agreed to continue withdrawal at home^‡ during spring break
Prescribed acetaminophen for analgesia and LUCEMYRA® (lofexidine) for relief of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation

Results/Follow-up

Patient had significant relief of OWS with LUCEMYRA treatment and was able to complete the 7-day treatment (three tabs 4 times a day).

After 7 days of treatment, the LUCEMYRA dosage was tapered over an additional 2 days (two tabs 4 times a day, then one tab 4 times a day).

After discontinuing LUCEMYRA, patient has remained off oxycodone and continued to manage back pain with acetaminophen and physical therapy.

She has resumed regular schedule of teaching and counseling.

^†LUCEMYRA potentiates the CNS depressive effects of benzodiazepines and can also be expected to potentiate the CNS depressive effects of alcohol, barbiturates, and other sedating drugs. Advise patients to inform their healthcare provider of other medications they are taking, including alcohol.

^‡Advise patients using LUCEMYRA in an outpatient setting that, until they learn how they respond to LUCEMYRA, they should be careful or avoid doing activities such as driving or operating heavy machinery.

Opioid Use Disorder

David O.*

42 years old

Opioid Use Disorder

Medical History

Medical history is significant for Opioid Use Disorder (OUD), which was diagnosed three years ago.

He currently sees a psychiatrist for cognitive behavioral therapy (CBT).

Opioid Use

Due to his history of OUD, patient has been maintained on buprenorphine 2 mg daily for the past two years.

Patient has since expressed his desire to discontinue buprenorphine. He reports feeling mentally ready to be free of opioids.

Over the past year, the patient has been stable on a 2 mg dose and reports trying to discontinue on his own but struggled due to symptoms of withdrawal.

After conferring with the psychiatrist, the patient is ready for discontinuation of buprenorphine therapy.

Opioid Discontinuation Treatment Plan

Patient’s opioid discontinuation plan was handled on an outpatient basis
Patient began 14-day treatment with LUCEMYRA^® (lofexidine) for relief of withdrawal symptoms following abrupt opioid discontinuation as part of a comprehensive management program
- For the first 12 days, the patient took three 0.18 mg LUCEMYRA tablets (0.54 mg) orally 4 times each day
- On Day 13, the patient took two 0.18 mg LUCEMYRA tablets (0.36 mg) orally 4 times
- On Day 14, the final day of treatment, the patient took one 0.18 mg LUCEMYRA tablet orally 4 times

Results/Follow-up

Patient completed withdrawal after 14 days on LUCEMYRA.

Patient continues to come in for routine follow up.

He appears to be stable off of buprenorphine, continues CBT, and is working closely with both his psychiatrist and his daughter as support.

Timothy C.*

40 years old

Opioid Use Disorder

Medical History

Medical history is significant for Crohn’s disease, depression, anxiety, and a prior diagnosis of Opioid Use Disorder (OUD) five years ago.

Current medications include infliximab and citalopram.

Patient works as a short-order cook, but with periods of unemployment.

Opioid Use

Last year, patient had two hospitalizations in four weeks due to exacerbation of Crohn’s. Patient did not mention his history of OUD and was discharged on 10 mg oxycodone, as needed every 4 to 6 hours, for 7 days.

After a short period, he was unable to obtain refills from his physician and obtained oxycodone from illicit sources. He stopped contact with his family and lost his job.

Diagnosis

Patient experienced symptoms of opioid withdrawal upon abrupt discontinuation of opioids, including increased anxiety, perspiration, palpitations, nausea, and stomach cramps.

Patient was referred to an addictionologist, who confirmed the diagnosis of OUD.

Opioid Discontinuation Treatment Plan

Patient’s opioid discontinuation treatment plan was handled on an outpatient basis
Treatment began with LUCEMYRA® (lofexidine) for relief of withdrawal symptoms following abrupt opioid discontinuation as part of a comprehensive management program

Results/Follow-up

Patient completed withdrawal after 12 days on LUCEMYRA (three 0.18 mg tablets taken orally 4 times daily for 9 days; dosage reduced by 1 tablet per dose over 3 days).

Patient successfully transitioned to treatment with depot naltrexone plus Cognitive Behavioral Therapy (CBT).

Patient has maintained naltrexone regimen for the past 5 months without relapsing into opioid use.

He continues CBT and is working closely with his PCP, a psychologist, and his sister as support. He has resumed part-time work as a cook.

Julie-Kay M.*

35 years old

Opioid Use Disorder

Medical History

Medical history is significant for fibromyalgia and depression.

Patient was diagnosed with fibromyalgia prior to current PCP assuming her care. She works full-time in administration at a law firm.

Opioid Use

Patient was initially treated by another physician for fibromyalgia. Patient also received duloxetine for depression. Lack of symptom improvement led to patient being prescribed a fentanyl patch (50 mcg/hr) every 3 days, plus hydrocodone bitartrate (10 mg)/acetaminophen (325 mg) as needed every 4 to 6 hours for breakthrough pain.

After two years on this regimen, a fentanyl taper was initiated and completed. She began treatment for fibromyalgia with pregabalin while continuing hydrocodone.

Within five months, she asked her PCP for an early refill of her hydrocodone prescription and to be placed back on fentanyl.

When told this would require an office visit for evaluation and a pain management consult, she broke off contact.

Diagnosis

Five months later, patient presented for an urgent consultation. She had been unable to work due to pain and other symptoms.

Patient had discontinued pregabalin.

She admitted to seeking opioid prescriptions from other physicians, and eventual use of illicit opioids. Recently she was unable to obtain any opioids. In the absence of opioids, she experienced symptoms including increased nausea, shaking, restlessness, and muscle spasms.

These were recognized to be symptoms of opioid withdrawal and she was diagnosed with Opioid Use Disorder (OUD).

Patient was referred to an addictionologist for further evaluation and treatment.

Opioid Discontinuation Treatment Plan

A treatment plan to address the patient’s OUD was discussed
LUCEMYRA® (lofexidine) was prescribed to mitigate withdrawal symptoms following abrupt opioid discontinuation as part of a comprehensive management program
Patient began 7-day course of LUCEMYRA (three tabs 4 times a day for 5 days) with 2-day taper (two tabs 4 times a day, then one tab 4 times a day)

Results/Follow-up

After she completed withdrawal, her specialist initiated buprenorphine as maintenance therapy.

She then attended an intensive outpatient treatment program as recommended by her psychiatrist.

Patient has been maintained on buprenorphine. She is making lifestyle changes and continues in therapy.

Next: Offer your patients a comprehensive patient support program

Reference: 1. Centers for Disease Control and Prevention. Calculating total daily dose of opioids for safer dosage. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose-a.pdf. Accessed January 13, 2021.

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LUCEMYRA® Videos

Hear from an HCP and patients about their experiences with LUCEMYRA

HCP Experience

Real Patient Experiences

Opioid Withdrawal Management: Patient Case Profiles

The following seven patient profiles represent patients who may be appropriate for treatment with LUCEMYRA. These include four patients with physical opioid dependence and three patients with Opioid Use Disorder (OUD)

Physical Opioid Dependence

Kaitlyn J.*

Medical History

Opioid Use

Opioid Discontinuation Treatment Plan

Results/Follow-up

Daniel T.*

Medical History

Opioid Use

Diagnosis

Opioid Discontinuation Treatment Plan

Results/Follow-up

Leonard D.*

Medical History

Opioid Use

Diagnosis

Opioid Discontinuation Treatment Plan

Results/Follow-up

Tracey A.*

Medical History

Opioid Use

Diagnosis

Opioid Discontinuation Treatment Plan

Results/Follow-up

Opioid Use Disorder

David O.*

Medical History

Opioid Use

Opioid Discontinuation Treatment Plan

Results/Follow-up

Timothy C.*

Medical History

Opioid Use

Diagnosis

Opioid Discontinuation Treatment Plan

Results/Follow-up

Julie-Kay M.*

Medical History

Opioid Use

Diagnosis

Opioid Discontinuation Treatment Plan

Results/Follow-up

Indication

Important Safety Information

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