Narrator:
Addressing setbacks, triggers and stigmas that may affect the patient journey, presented by Dr. Brent Boyett and Dr. Tipu Kahn.
SUBLOCADE® (buprenorphine extended-release) is for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product for a minimum of seven days. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
SUBLOCADE has a Boxed Warning:
Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids, and may a cause occlusion, local tissue damage, and thromboembolic events including life threatening pulmonary emboli if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with REMS requirements.
See additional Important Safety Information and full Prescribing Information including BOXED WARNING and medication guide at sublocadehcp.com.
This HCP experience video contains the personal views, opinions, and experiences of the featured physicians. Each physician has been compensated by Indivior® for their participation in the video’s creation. HCPs should exercise their own independent judgement in deciding how to clinically treat the patients they see.
Dr. Brent Boyett:
Addiction is a biopsychosocial disorder. So, what causes people to fall out of treatment? What causes people to have setbacks? It can be a whole variety of things. But in my clinical experience, it can largely be summed up as cravings. And cravings can be divided into two categories.
The first is tonic. Tonic craving is usually based upon internal biochemical influences like plasma concentrations of an opioid. It’s an inverse relationship. For example, the higher the plasma concentration of buprenorphine the lower the tonic craving. Adequate plasma levels of buprenorphine can help control tonic craving. Then the second type is phasic craving, which is typically caused by environmental influences. Phasic craving is generally triggers. Triggers can be subdivided into two categories: positive triggers and negative triggers. Positive triggers are running towards something like a temptation such as people, places, and things that remind the subconscious of the reward of using. But there is also negative triggers which can be caused by dysphoric feelings.
Think of it as running away from pain. I found that teaching patients to identify triggers can help. Stigma can cause setbacks and is still an issue today. I believe those of us in the treatment community have a duty to educate the public at large on the disease model of addiction and the evidence-based, scientifically-proven approach to the treatment of addiction. It’s an educational process, and I consider myself as much a teacher as I am a doctor. In my experience, the patient gets on the same page with a provider, and they understand what they’re trying to do and what the whole purpose of the therapy is.
That’s when we start making real progress. I believe that medications for OUD, whether that’s SUBLOCADE, naltrexone, or buprenorphine, should be part of an integrated treatment approach that involves motivational enhancement, education, encouragement, surveillance, and accountability.
Dr. Tipu Khan:
Opioid use disorder is a chronic relapsing remitting disease. It’s a roller coaster of a disease, and that’s exactly what I talk to patients about when we start treatment. I tell them that there are going to be times that are good, and there going to be times that you aren’t meeting the goals you’ve set, and that’s okay. That’s part of the disease process. And I set that tone with my patients that you will never be judged or stigmatized in our clinic. If you have a relapse, you will not be kicked out of our clinic. I make it really clear to patients that we understand addiction as a chronic disease, so let’s assess what happened, and let’s see how we can better control this. Having that conversation initially with my patients and letting them know this is what’s going to happen, it supports them and helps them feel destigmatized. And it helps create honesty between us.
Later when they come in and say, “I didn't do so well last month. I’ve been using again,” or, “This is what’s going on.” They know I’m there to help them, and will meet them where they’re at and not judge them. So, that’s an important attitude and mantra that we preach in our clinic when treating opioid use disorder. Many of my patients suffering from opioid use disorder have a lot going on. Oftentimes these patients are dealing with not only their medical condition and associated symptoms, but also drug court and child and family services. They’re trying to get custody of their kids back, they’re trying to get a job. They’re trying to get their GED. They’re trying to be productive members of society. But sometimes they experience difficulties in care such as their buprenorphine provider is not available. And there’s no one in the practice to refill their sublingual. Or they can't find a provider locally to treat their opioid use disorder. All these things can set them back two or three steps from where they just were. I think it’s important we acknowledge these as risk factors and help patients understand that there’s always a place they can go.
From a logistical standpoint there are a few things that I believe can help ensure continuity of care. In my practice we have open scheduling with walk-ins available and expanded clinical hours. Also, telehealth has really helped change our approach to opioid use disorder, especially with homeless patients who may have a phone, but just can't get to their appointment for a number of reasons. Telehealth allows me to check in with patients, refill their sublingual buprenorphine, or if they’re on SUBLOCADE, check to see how they’re doing and schedule the nurse visit for an injection.
Dr. Brent Boyett:
I believe SUBLOCADE fits into the treatment approach in a few different ways. Before I initiate it though, I ensure that my patients are stable on transmucosal buprenorphine. When transitioning from the inpatient setting, we do have the patient somewhat stable of course. But from what I’ve seen, the most vulnerable time for the patient is just after discharge.
With SUBLOCADE on board during those vulnerable periods, that gives me some reassurance. Based on my experience, when the plasma concentrations of buprenorphine are high, people tend to do well, but when they fall, they tend to do not so well. SUBLOCADE helps even out plasma concentrations of buprenorphine. I've seen that it may help smooth the transition of care in many ways. Many of my patients feel they no longer have to worry about daily medications, losing their medications, or from where they’re going to get their next dose.
Dr. Tipu Khan:
So many of my patients with opioid use disorder struggle with the return to substance use for a lot of different reasons. I need to get them to a higher plasma concentration over the two nanograms per milliliter level that gives us adequate receptor occupancy. I found that the higher receptor occupancy allows my patients to have better control over their disease and lives, fewer cravings, and greater likelihood of staying in recovery.
What I found is that SUBLOCADE is appropriate for my patients who need freedom from a daily medication. I say to patients, “Let me get you on SUBLOCADE because it’s a once-a-month injection that’ll get you to plasma concentration that will help you get the results you’re seeking.” I point out that when you’re taking sublingual buprenorphine, you get this dose that goes up, but then it wears off throughout the day. And it does that over and over and over throughout the month. And if you experience a trigger while you’re on the down part of your dosage, you may end up feeling, “I need to get up again, so I’m gonna use a little bit of opioid to feel better.”
Once a patient has initiated and stabilized on SUBLOCADE, you get this consistent two nanograms per milliliter level or above, which is really what we’re aiming for. So, it avoids the peaks and troughs. And once we have a plasma concentration stability, that gives my patients the opportunity to be more active and do more of the things they need to do throughout their day and not worry about troughs.
I think it empowers my patients to feel stable throughout the entire day. When I talk to them about their experience on SUBLOCADE, they tell me it’s liberating to not have to take a medication every day. It’s just in the background doing its job. That allows my patients to focus on the psychosocial aspects of recovery. When I start seeing patients and assessing them, if they’re high risk from a biopsychosocial standpoint, I tell them, “Why don't I remove one variable out of this equation for you? What if I can get you on SUBLOCADE and give you a once-a-month injection so you’re not dealing with a daily medication?” Over the last few years, what I’ve learned is that SUBLOCADE is an appropriate medication option for those patients that need to be free from taking something every single day, so I offer it early in their treatment course.
[End of Audio]
SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII
HCP Indication and Important Safety Information
INDICATION
SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII, is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
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WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
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IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: SUBLOCADE should not be administered to patients who are hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Buprenorphine is sought by people with opioid use disorder and is subject to criminal diversion. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Risk of Life-Threatening Respiratory Depression and Concomitant Use of Benzodiazepines or Other CNS Depressants with Buprenorphine: Buprenorphine has been associated with life‐threatening respiratory depression, overdose, and death, particularly when misused by self-injection or with concomitant use of benzodiazepines or other CNS depressants, including alcohol. Warn patients of the potential danger of self-administration of benzodiazepines, other CNS depressants, opioid analgesics, and alcohol while under treatment with SUBLOCADE. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider.
Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).
Opioids can cause sleep-related breathing disorders; e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs.
Strongly consider prescribing naloxone at the time SUBLOCADE is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and, if naloxone is prescribed, how to treat with naloxone. Emphasize the importance of calling 911 or getting emergency help, even if naloxone is administered.
Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration, and necrosis. Some cases resulted in surgical depot removal, debridement, antibiotic administration, and SUBLOCADE discontinuation. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration. Carefully review injection technique.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Newborns should be observed for signs of NOWS and managed accordingly. Advise pregnant women receiving opioid addiction treatment with SUBLOCADE of the risk of neonatal opioid withdrawal syndrome.
Adrenal Insufficiency: Adrenal insufficiency has been reported with opioid use. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off the opioid.
Discontinuation of SUBLOCADE Treatment: Due to the long-acting nature of SUBLOCADE, if treatment is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Inform patients that they may have detectable levels of buprenorphine for a prolonged period of time after treatment with SUBLOCADE. Considerations of drug-drug interactions, buprenorphine effects, and analgesia may continue to be relevant for several months after the last injection.
Risk of Hepatitis, Hepatic Events: Because cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving buprenorphine, monitor liver function tests prior to treatment and monthly during treatment.
Hypersensitivity Reactions: Hypersensitivity to buprenorphine-containing products have been reported most commonly as rashes, hives, and pruritus. Some cases of bronchospasm, angioneurotic edema, and anaphylactic shock have also been reported.
Precipitation of Opioid Withdrawal in Patients Dependent on Full Agonist Opioids: Buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. Verify that patients have tolerated and are dose adjusted on transmucosal buprenorphine before subcutaneously injecting SUBLOCADE.
Risks Associated With Treatment of Emergent Acute Pain: When patients need acute pain management, or may require anesthesia, treat patients receiving SUBLOCADE currently or within the last 6 months with a non-opioid analgesic whenever possible. If opioid therapy is required, patients may be treated with a high-affinity full opioid analgesic under the supervision of a physician, with particular attention to respiratory function, as higher doses may be required for analgesic effect and therefore, a higher potential for toxicity exists with opioid administration.
Advise patients of the importance of instructing their family members, in the event of emergency, to inform the treating healthcare provider or emergency room staff that the patient is physically dependent on an opioid and that the patient is being treated with SUBLOCADE.
Use in Opioid Naïve Patients: Because death has been reported for opioid naïve individuals who received buprenorphine sublingual tablet, SUBLOCADE is not appropriate for use in opioid naïve patients.
Use in Patients With Impaired Hepatic Function: Because buprenorphine levels cannot be rapidly decreased, SUBLOCADE is not recommended for patients with pre-existing moderate to severe hepatic impairment. Patients who develop moderate to severe hepatic impairment while being treated with SUBLOCADE should be monitored for several months for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.
QTc Prolongation: QT studies with buprenorphine products have demonstrated QT prolongation ≤ 15 msec. Buprenorphine is unlikely to be pro-arrhythmic when used alone in patients without risk factors. The risk of combining buprenorphine with other QT-prolonging agents is not known. Consider these observations when prescribing SUBLOCADE to patients with risk factors such as hypokalemia, bradycardia, recent conversion from atrial fibrillation, congestive heart failure, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, or severe hypomagnesemia.
Impairment of Ability to Drive or Operate Machinery: SUBLOCADE may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Caution patients about driving or operating hazardous machinery until they are reasonably certain that SUBLOCADE does not adversely affect their ability to engage in such activities.
Orthostatic Hypotension: Buprenorphine may produce orthostatic hypotension.
Elevation of Cerebrospinal Fluid Pressure: Buprenorphine may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation.
Elevation of Intracholedochal Pressure: Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.
Effects in Acute Abdominal Conditions: Buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Unintentional Pediatric Exposure: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
ADVERSE REACTIONS: Adverse reactions commonly associated with SUBLOCADE (≥5% of subjects) during clinical trials were constipation, headache, nausea, vomiting, increased hepatic enzymes, fatigue, and injection site pain and pruritus. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.
DRUG INTERACTIONS
CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing.
Serotonergic Drugs: If concomitant use with serotonergic drugs is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug.
Consult the full Prescribing Information for SUBLOCADE for more information on potentially significant drug interactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.
Lactation: Buprenorphine passes into the mother’s milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.
Fertility: Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Geriatric Patients: Monitor geriatric patients receiving SUBLOCADE for sedation or respiratory depression.
To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966.
See full Prescribing Information, including BOXED WARNING, and Medication Guide, or for more information about SUBLOCADE, visit www.sublocadehcp.com. For REMS information visit www.sublocadeREMS.com.
SUBLOCADE® and INDIVIOR® are registered trademarks of Indivior UK Limited.
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P-BAG-US-01296 EXPIRY April 2025