Considering stigmas, education gaps, and the need for scientific understanding when prescribing treatments for moderate to severe OUD, presented by Dr. Tipu Khan and Dr. Brian Gadbois.
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 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 subcadehcp.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 judgment in deciding how to clinically treat the patients they see.
Dr. Tipu Khan:
OUD is a complex, chronic, relapsing disease that has both medical and psychosocial components to it, which can make it really difficult to treat. So, I'll start with the medical part.
The introduction of synthetic opioids, specifically fentanyl and fentanyl analogues that have been introduced into the United States in the last few years, have really changed the way I approached the treatment of opioid use disorder with medications. In general, these illicit opioids are highly addictive. They have a high affinity for the receptor and they have the ability to build up in adipose tissue over time, which makes it almost function like a long-acting opioid, which makes induction oftentimes very difficult for these patients, and is not as straightforward as I used to do with short-actings like heroin in the past.
From a medical standpoint, and a MOUD standpoint, one of the biggest barriers I face in my practice is how to tackle the management of high-potency synthetic opioids that exist today. And that's where I think long-acting injectable buprenorphine really comes into play there. There are a lot of good options for medications in the OUD treatment algorithm. I think one of the attributes of SUBLOCADE is that it gets most of my patients to the two nanograms per milliliter plasma concentration.
A long-acting injectable in today's synthetic opioid setting offers my patients an option to provide stability of medication, rather than the ups and downs we typically see with daily dosed medications. I think the next challenge is stigma. For a long time, patients were stigmatized. They were failed by the health care system and by us as providers. But over the last few years, of course, because nearly everyone has someone that's been affected by this disease, we as a society have finally started to change the way we approach OUD with more understanding and resources for treatment, prevention, and harm reduction.
One of the other big challenges with the treatment of any substance use disorder, but specifically opioid use disorder, is understanding the disease itself. In the past, we as providers, including myself, used to beat home in patients' minds that they just have to make that conscious decision to say no to drugs. And if they didn't, it was their fault. They were weak-willed or they just couldn't get it together.
I've learned over the last 15 years or so with a lot of good data, evidence, and scientific research, that substance use disorders are a chronic, relapsing, remitting disease involving neurochemical pathways in the brain. I talk with patients about the medical model of substance use disorder to help them understand that this is a chronic disease like diabetes or high blood pressure. We don't stigmatize patients for having diabetes or high blood pressure.
I make a point of helping patients understand that medications, along with counseling for opioid use disorder, are the standard of care. And yes, you may need to be on the medication the rest of your life, and that's perfectly okay because we're treating a chronic disease. We're not replacing one drug with another. I think that helps break down those barriers that some of my patients face when they think about long-acting treatment and long-term treatment for OUD.
Dr. Brian Gadbois:
There are several challenges in managing patients with opioid use disorder, but I believe they can be overcome.
Generally speaking, for some of my patients with opioid use disorder, staying consistent on daily medication may be a challenge, and following that, the consequences of a return to illicit opioid use is a concern. There are also logistical barriers to care for patients like getting transportation for a drug screen or to pick up medication or to get their shot. Triggers can also be an obstacle to successful treatment. This is where psychosocial interventions play a role in providing coping skills.
Unfortunately, stigma remains a major challenge and I think more people would enter care if it weren't for that. They might seek medication, but don’t, because they have that drug-for-drug mindset and think they can do it themselves the old-fashioned way. Educational gaps exist in general within the medical community, as well as with stakeholders such as patients' friends, family, or other institutions. It can be difficult to get people on board with maintenance treatment as opposed to acute treatment and communication is key.
Underutilization of MOUD is another challenge that may stem from a variety of underlying reasons. Providers may wonder about logistics such as, what if we don't have a lab to do drug screens? What if the pharmacy is far away? What if the nursing staff for injections isn't available in this location? As providers, we really do want to help our patients and we need the community to understand that people are needlessly dying. Look at the statistics of the epidemic and think about how different the situation would be if we got everyone on effective treatment.
When you see those staggering numbers, it can really be an eye-opening experience and help motivate people to make changes in their practice. They may consider, “maybe this is worth getting a little bit more education or moving that nurse for half a day to a different location to help with injections or adding drug screening in a particular location.” I think that continued outreach and education will help to overcome some of these challenges.
Dr. Tipu Khan:
Having SUBLOCADE, an extended-release injectable buprenorphine that you give once a month, is an appropriate option for my patients in my practice. It achieves a plasma concentration comparable to transmucosal buprenorphine without daily ups and downs, and this really matters in my practice because I work with a very high-risk patient population. These are typically patients that are underserved, often homeless, or they're in and out of the incarceration system and psychosocial determinants of health are working against them. So, in these patients, asking them to remember to take a medication every single day, not get stolen, not have it lost, is really hard. SUBLOCADE helps to provide steady therapeutic buprenorphine plasma levels and removes the burden of taking OUD medication every day.
I think it empowers some of my patients to be able to say, "Hey, I don't have to worry about going into clinic this week, or talking to my doctor to get a refill, or remembering to take my buprenorphine to work with me." They know the medication is on board, it's working, and they can focus on other parts of their recovery. I know my patients will function on an extended-release injectable. If I can get them on SUBLOCADE early in the treatment process, I have a chance of maintaining sufficient receptor occupancy even when my patients are in unstable social situations. So, I'm a fan of getting SUBLOCADE started early in my high-risk patients.
Dr. Brian Gadbois:
With SUBLOCADE, you have once monthly dosing and sustained medication delivery. In my experience, my patients taking SUBLOCADE don't have to worry about getting out of bed to take a daily OUD medication or getting to the clinic right away for their daily dose. Not feeling burdened by daily dosing is one of the things I've heard repeatedly from patients. Another kind of trigger that comes to mind is payday.
Some of my patients say, "I know when that check hits, I'm going to want to go out and use." This is a common situation when a patient might choose to not go to clinic or will stop taking their at-home medicine for the weekend because they know that trigger is there and they'll be ready to use. For my patients with the continuous month-long delivery of SUBLOCADE, it's not an option to skip taking their OUD medicine over the few days of that weekend. Dealing with moving can be challenging as well.
I think SUBLOCADE may offer some flexibility when my patients relocate. I have patients who finish a level of care and then move some distance away. While it might not be feasible for them to come on a weekly basis because of the distance, they can make the drive once a month.
[End of Audio]
SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII
HCP Indication and Important Safety Information
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.
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
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.
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.
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-01294 EXPIRY April 2025