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See how your peers include SUBLOCADE® in their practices

See your peers' experiences with SUBLOCADE: the first FDA-approved, once-monthly buprenorphine treatment option for patients with moderate to severe OUD1

Patients' Experiences

Dr. Arwen Podesta and Dr. Brian Gadbois

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Initiating SUBLOCADE and the impact that once-monthly dosing has on certain patients with OUD

Narrator: Initiating SUBLOCADE® and the impact that once-monthly dosing has on certain patients with OUD, presented by Dr. Arwen Podesta and Dr. Brian Gadbois. SUBLOCADE 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 7 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 thrombo-embolic 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.

[00:01:00] 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 judgment in deciding how to clinically treat the patients they see.

Dr. Arwen Podesta: I've always been a fan of long-acting injectables for patients. When the opportunity arose to use an extended-release treatment for my opioid use disorder patients, I was eager to adopt it. SUBLOCADE is given once monthly, as opposed to having patients take oral medication every day, sometimes two or three times a day.

[00:02:02] There's a psychological switch when my patients go from a daily, oral medication to a monthly injectable. I've had many patients that initiated SUBLOCADE. And what I find is that most of them have a change in their way of thinking about their addiction treatment because they're not consumed with a daily regimen of taking their medication.

Dr. Brian Gadbois: I had a set of patients who struggled with their treatment plan, and I wanted to see if a long-acting injectable could make a difference. For example, some patients had trouble taking their medications consistently. Some still had issues with returning to opioid use, which at times led to hospitalizations. It seemed to me these patients needed something different. In some cases of hospitalization, there were problems getting my patients back on their medications. This may have been due to availability of addiction specialty consultation. In other cases, patients may not have been interested in or able to connect with a methadone clinic.

[00:03:00] And still, some others felt that they couldn't get through a week or longer of being illicit opioid-free in order to start antagonist medications. And thinking about the options available to my patients, where it seems like “they can't do this. They can't do that.” Then, what do they do? I realized I need to try SUBLOCADE for the first time on a patient, so I can try a different approach. In my experience, this approach helped my patients with some of these problems. Because of that and my other outpatient experiences, I now routinely offer SUBLOCADE for appropriate patients.

Dr. Arwen Podesta: Treatment with SUBLOCADE means that my patients don't have to scramble to find medication on a daily basis. If they're traveling, they don't have to worry about bringing the medication with them. Since oral buprenorphine is also a scheduled medication, it can be hard to find or transport to certain countries. So, my patients feel safe with their once-a-month injectable.

[00:04:00] With this medication, I also find that patients do not have to worry about taking their opioid use disorder medication one to three times a day. Along with SUBLOCADE, I use psychosocial support, individual and core group therapy, and sometimes peer support for many patients.

Dr. Brian Gadbois: Regarding my experience with SUBLOCADE, what I see in the clinic is pretty consistent with the clinical trials data. Some patients are initially concerned about it working and lasting through the month, but most of my patients usually see efficacy relatively early in the course of treatment. With SUBLOCADE, you have once-monthly dosing and sustained medication delivery. My patients taking SUBLOCADE don't have to worry about getting out of bed to take medication for opioid use disorder first thing in the morning or getting to the clinic right away for their daily dose. One of the comments I've heard repeatedly from patients is, “I can focus on other things.”

[00:05:00] Some patients have told me that they appreciate not needing to remember to take a daily dose, which may itself be a daily reminder of their struggles with OUD. I think it's important to note that some of the clinical trial data does show a large degree of inter-individual variability in buprenorphine blood levels. And I also see some clinical correlation with that in my practice. I think the more patients you treat, the better you understand how it comes through in patient reports of symptoms. It would be nice to be able to get plasma levels in some of these instances, but that's not really an option where I practice, so, I rely on reports of symptoms to guide my decision-making.

So, on one hand, I've seen patients who did well all the way through treatment with SUBLOCADE, following the first injection, month after month with few issues. On the other hand, I have some patients who may say their experience is something like, “Doc, towards the end of the month I felt like I didn't sleep as well. I was a little sweatier in that last week before the next shot.”

[00:06:03] In my experience, if my patients report some symptoms towards the end of the first or second month, those symptoms may improve with continued treatment. In those cases, I generally keep the patient on the higher SUBLOCADE dose past the second month since it seems they may need higher blood levels to feel better. Then, after a period of stability when they feel well-treated, we revisit the idea of reducing their dose. I've found that in patients who do not feel adequately treated right away or are troubled by injection site pain, getting them through the first few months of SUBLOCADE treatment is important.

For these patients, reassurance and education are key to helping them understand that SUBLOCADE is gradually released into the bloodstream, plateaus over four to six months, and that we do have the option to stay at the higher dose. I also remind the patient that if they have rough patches when starting SUBLOCADE, we can use supportive medications or other interventions to help move past those challenging times.

[00:07:03] In my practice, SUBLOCADE is now one of my main medication options for treating moderate to severe opioid use disorder. While I may have initially started treatment with more severe cases, I think anyone who meets appropriate criteria should be offered SUBLOCADE as a treatment option. I don't want my patients to have to wait to access SUBLOCADE. I don't think my patients should have to go through a failure of their current treatment in order to have access to SUBLOCADE. They just have to do well with initiation and stabilization of transmucosal buprenorphine for seven days. Otherwise, I don't think they should have to jump through hoops to be able to access the medication.

[End of Audio]

Duration: 8 minutes

Goal-Oriented Conversations

Dr. Brent Boyett and Dr. Paolo Mannelli

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Setting patient expectations and goals when initiating SUBLOCADE, and considering a long-term solution

Narrator: Setting patient expectations and goals when initiating SUBLOCADE®, and considering a long-term solution. Presented by Dr. Brent Boyett and Dr. Paolo Mannelli. SUBLOCADE 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 7 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 thrombo-embolic 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.

[00:01:00] 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 judgment in deciding how to clinically treat the patients they see.

Dr. Brent Boyett: I explain to patients that addiction medicine is the field that helps patients establish and maintain a functional balance between the perception of pain and pleasure. This includes both emotional and physical perceptions. Once this hedonic tone is balanced, recovery is possible.

[00:02:02] Our approach to the treatment of OUD, as with addiction in general, is focused on the biopsychosocial model of chronic disease management. In aviation, we say, “Take off is optional, but landing is mandatory.” And we really need a flight plan to help deliver that landing. When I'm seeing patients, I make sure to communicate that we have to agree on the goals of the treatment because if the patient has one set of goals, and I as the treatment provider have another, that's a recipe for conflict.

In my practice, I believe it's important to lay out the treatment agreement on day one or at the initiation of therapy. This written document is agreed upon by me, the treatment provider, and the patient that says, “This is the goal of therapy, and this is how we plan to get there.”

[00:03:00] It's a flight plan, so to speak. When I discuss clinical attributes of SUBLOCADE with patients, I talk about steady-state plasma concentration levels and how they are important for healing. I tell my patients that with SUBLOCADE, the plasma concentrations reach steady state without peaks and troughs in about four to six months.

In my observation with transmucosal buprenorphine, even with maximum dose given on a 24-hour dosing schedule, the plasma concentration levels frequently fall below the two nanograms per milliliter threshold. [SW1] When I introduce SUBLOCADE, it's comforting to know that my patient doesn't have to concern themselves with a daily dosing ritual, which many would agree is reinforcing. With once-monthly SUBLOCADE, I, as the treatment provider, remove the operant conditioning of the dose response and the reinforcement of having to take something.

[00:04:04] I sometimes tell my potential patients that those who are currently being treated with SUBLOCADE really like the freedom from dosing schedules on a daily basis. It's not part of their daily routine anymore.

Dr. Paolo Mannelli: What I try to communicate in my practice is that the only short-term goal can be, “Let's work together.” I try to help the patient understand that there is no short-term solution to opioid use disorder. One important initial goal I try to communicate is to recognize how to be in the recovery phase and try to find a functioning level that works for the patient on a daily basis.

[00:04:56] The longer-term goals that I often hear from my patients and also work through with them include trying to stay clean, avoiding drug temptations, getting social and psychosocial support, and starting to build the future after drugs. I try to let them know that “right now, we are doing what we need to do for you to be safe. At the same time, we are helping to move you away from opioid use.” I involve my patients in the decision-making process based on where they are now.

Some goal-oriented questions I often ask patients include, “What is your situation? What do you need now? Do you have a job? Do you need to provide for your family? How can you find time to take care of yourself and of the needs of others?” OUD patients often lack the ability to project themselves into the future.

[00:06:00] Every day is like Groundhog Day. It's always just today. So, the ability of discussing with a patient short-term project, that goes for a week, a month, and so on, is helping them imagine themselves going through treatment and to understand what treatment can do to bring them into the future.

I try to keep my patients focused on what they have now, what they have gained, and what they can lose if treatment does not progress[SW2] . In this way, cravings and lapses assume a real meaning. The idea that my patients can erase a drug experience from their mind is appealing, but unrealistic, as a memory of the drug will remain stored in their brain. And it's a potential trigger of drug-seeking behavior. Sometimes the bright spots related to my patients' treatment are small.

[00:07:02] It depends on their baseline condition. Anytime they can deny a drug-related behavior, these are all bright spots in my opinion.

Dr. Brent Boyett: With transmucosal buprenorphine, I, as a treatment provider, feel like I'm operating on “just-in-time” management. So, in other words, a patient is given just enough medication to keep them stable until the next time. That comes with some issues in unexpected events like inclement weather. At the end of that just-in-time delivery, there's a hard stop. That patient will be without medication. In contrast, when the steady state of SUBLOCADE is reached, there is not such a hard stop. And it gives my patients more leeway in situations that might impede them from getting to their next appointment or getting their next dose of buprenorphine.

[00:08:06] Dr. Paolo Mannelli: I tell patients that SUBLOCADE can help them more in their daily routine than therapy alone and help with their ability to refrain from using opioids. In my experience, all this makes room for the individual recovery process with the help of professionals and their family. Many of my patients who look to SUBLOCADE have been on long-term oral buprenorphine treatment. And they are interested in alternatives. They have experienced the ups and downs of daily treatment. At that point, I generally propose an alternative and explain that there is a buprenorphine injectable formulation that can help.

[00:09:00] Some questions I ask my patients are, “Do you want to talk more about this? Do you want to learn what an extended-release treatment can do?”

[End of Audio]

Duration: 10 minutes

Common Challenges

Dr. Tipu Khan and Dr. Brian Gadbois

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00:00

Considering stigmas, education gaps, and the need for scientific understanding when prescribing treatments for moderate to severe OUD

Narrator: 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® 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 7 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 thrombo-embolic 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.

[00:01:00] 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 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.

[00:02:00] 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.

[00:03:00] 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.

[00:04:00] 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.

[00:05:00] 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.

[00:06:00] 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.

[00:07:00] 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. [SW1] 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.

[00:08:00] 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.

[00:09:00] 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]

Duration: 10 minutes

Transition of Care

Dr. Tipu Khan, Dr. Arwen Podesta, and Dr. Brent Boyett

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00:00

Managing challenges presented in patients' transition of care during OUD treatment

Narrator: Managing challenges presented in patients' transition of care during OUD treatment presented by Dr. Tipu Khan, Dr. Arwen Podesta, and Dr. Brent Boyett. SUBLOCADE 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 7 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 thrombo-embolic 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.

[00:01:00] 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 judgment in deciding how to clinically treat the patients they see.

Dr. Tipu Khan: Transition of care is an area where I often use SUBLOCADE in my high-risk patients. For example, I work in a county setting with patients that are in and out of the jail system, or homeless, or in sober living situations that don't offer and don't allow patients to come in with sublingual buprenorphine or other MOUD that have to be taken daily.

[00:02:00] In these situations, I really want to get something on board that my patient doesn't have to worry might be denied where they're going. Thinking back to another example of a patient I saw in the hospital last week on addiction medicine consult, this patient came from a home, but was struggling with her opioid use disorder because they had too many triggers there. Unfortunately, the sober living home she was going to did not allow sublingual buprenorphine. Yet we had stabilized this patient in the hospital. And she was on a good dose of sublingual buprenorphine, and was tolerating it well.

This patient was good candidate for SUBLOCADE, so I said, “Hey, can I get you on a monthly extended-release injectable buprenorphine that will give you the treatment you're seeking and allow you to function in the facility you're going to?” We gave her SUBLOCADE injection, and that really bridged the transition of care for her. I've got multiple examples of having done that over the years with good success. I think the other opportunity to think about is incarcerated patients. Often, jail systems still don't allow sublingual buprenorphine, and if they do, they're providing really low doses that are subtherapeutic.

[00:03:04] These patients could benefit from an extended release injectable. Any time patients are transitioning from one level of care into another there are gaps that can open up. In my practice, I think what has really helped us is having substance use navigators who regularly connect with patients. They check in on them sometimes every day for the first week to see how they're doing, assess their cravings and use, as well as their safety, and coordinate care for them. Substance use navigators are trained in motivational interviewing, as well as peer-to-peer support, and are really advocates for these patients in transition.

Dr. Arwen Podesta: Based on my experiences, coordination of care between care settings is imperative. When I think of coordination of care, I think of starting at a higher level of care, and then moving to a medium, and then to a lower level of care. When a patient comes in my first thought is usually, “What's next?” And that requires that I have an idea of a discharge plan in my notes.

[00:04:02] From that the nurses and other staff also know how to transition care. Additionally, in my practice, there typically is a social worker who is familiar with these same care transitions and coordinates appropriately. If someone's leaving residential inpatient treatment, I usually like for them to stay in the area and go into an intensive outpatient program with some of the same counselors and doctors for eight to 12 weeks, then go over to outpatient. And these transitions can happen in either direction. They can go from a higher level of care to a lower level or a lower level to a higher level as needed.

But in my experience, these transitions usually go well when everyone collaborates, including all the treatment facilities in the area. I'm very involved in my state addiction treatment groups. I network everybody together. I know what locations take what insurance and have beds available or have spots available. And I know what locations take outpatient primary care for medication-assisted treatment. With all of my patients, I set goals, not just on refraining from opioid use but on wellness.

[00:05:04] And I want to make sure that patients choose those goals with me. And then I check in with them every time I see them. I also use those goals for the therapist to set parameters of what we would say is success for the patient. That said, some of those goals are short-term, such as becoming opioid-free today, staying in treatment, cleaning out the drugs from their car or their house, or changing the phone numbers in their phone and working toward the long-term goal of real stability. Toward the maintenance phase, my patients who are taking a medication daily, it is then that I'd like to see them transition to a long-acting injectable medication, so that they have a different psychological relationship with their medication and therefore with their addiction.

Dr. Brent Boyett: In my practice, transition of care is usually one of my top priorities of treatment.

[00:06:00] And a patient who knows exactly where they are going when they are discharged can be better prepared in my opinion. I believe all settings, whether it's an incarceration setting, inpatient, outpatient, or residential treatment, should plan for continuity of care. In my practice, I begin discharge planning on Day 1. When I took over as a medical director of an opioid and alcohol facility, I was dedicated to making transition of care seamless and automatic. When a patient came to my rehab, discharge planning began that same day. Prior authorizations would begin, and referrals for aftercare would be set up.

Sometimes we would have “lane change” or the patient or the provider decided that they needed a different change in the treatment, and we would redirect the discharge planning to reflect that. Many patients I come across believe that detox is an addiction cure.

[00:07:00] I try to explain the importance of functional balance and that they live in a state of constant dysphoria, and they're compelled to soothe their pain with chemicals. But that's a hard message to get. And that's the reason for the revolving door issues in rehab. The public and many providers still think that chemical detox is all that is involved in addiction care and the rest is just a moral and ethical problem.

Dr. Arwen Podesta: I often start patients on SUBLOCADE right before the end of an inpatient treatment. When my staff gives the injection the day before they walk out the door, I believe my patients and their families may feel reassured that the patient has begun to receive continuous medication treatment through their next dose. If the patient is transitioning from intensive outpatient to outpatient care I prefer to give SUBLOCADE injection in the middle of the intensive outpatient program so that the patient is comfortable with it before moving onto their outpatient care.

[00:08:06] In my experience, in transitions from one level of care to another, using SUBLOCADE takes some weight off my patient's minds. My patients don't feel that potential pressure to find that next dose of medication. For example, just recently I was contacted by an outpatient prescriber who was starting to see a new patient who had been at an inpatient facility. The facility had only given the patient one week's supply of daily sublingual buprenorphine. My colleague and the outpatient clinic, however, didn't have an appointment for three weeks, so the patient was going to run out of medication. If they had been given SUBLOCADE, that wouldn't be a problem.

Dr. Brent Boyett: I found that in transitions having the consistent plasma concentration of extended-release injectable buprenorphine provides reassurance to my patients that they will have some protection, as bad things can happen in all sorts of circumstances during transitions, environmental circumstances, internal circumstances.

[00:09:03] Without MOUDs, some patients may be at increased risk for retuning to opioid use.

[End of Audio]

Duration: 10 minutes

Patient Journey

Dr. Brent Boyett and Dr. Tipu Khan

0
00:00

Addressing setbacks, triggers, and stigmas that may affect the patient journey

Narrator: Addressing setbacks, triggers and stigmas that may affect the patient journey, presented by Dr. Brent Boyett and Dr. Tipu Kahn. SUBLOCADE 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 7 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 thrombo-embolic 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.

[00:01:00] 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 judgment 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.

[00:02:00] 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.

[00:03:03] 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.

[00:04:09]

Dr. Tipu Khan: Opioid use disorder is a chronic relapse 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.

[00:05:00] 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.

[00:06:00] 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.

[00:07:00] 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.

[00:08:03] 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.

[00:09:00] 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.

[00:10:00]

[End of Audio]

Duration: 10 minutes

Patients' Perspectives

Dr. Brian Gadbois, Dr. Paolo Mannelli, and Dr. Arwen Podesta

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Understanding a patient's motivation to provide a customized treatment plan

Narrator: Understanding a patient's motivation to provide a customized treatment plan. Presented by Dr. Brian Gadbois, Dr. Paolo Mannelli, and Dr. Arwen Podesta. SUBLOCADE 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 7 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 thrombo-embolic 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.

[00:01:00] 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 judgment in deciding how to clinically treat the patients they see.

Dr. Brian Gadbois: Patients' motivations are different whether they see me on a voluntary or involuntary basis. I think the point in the recovery is different and their goals may be different. For the voluntary, or treatment-seeking, patients who I see, they usually present on their own asking for help. They're saying things like, “My life is unmanageable.

[00:02:01] I need help. I want to get on medication.” In my experience, those patients tend to approach things a lot differently than patients who, for example, are in court-ordered, long-term residential treatment. They're sort of a captive audience who, if it weren't for their legal issues and current circumstances, they probably wouldn't be seeking treatment from me. So, I consider that sort of patient more of an involuntary or a non-treatment-seeking patient. I had one involuntary patient tell me, “I only chose this medicine because I can't get what I really want.”

Now that sort of statement can be worrisome, but regardless of their motivation, the patient's perspective may still be consistent with getting them on medication for opioid use disorder and getting the benefits of being on treatment. So, whatever a patient's motivation is, I try to lean into how it can lead to treatment benefits. When I check in with either of these patient types, I ask about symptoms, side effects, and cravings.

[00:03:03] Patients may indicate they have experienced these. They may say they have been sick to their stomach, experiencing diarrhea or pain. But for some, on further questioning, they may also report congestion, cough, and fever, as well. So, I've found that the symptoms may not actually be withdrawal symptoms related to the medication, but from a viral infection going around. So, being able to tell the difference takes some time and effort during the discussion at follow-up visits. For patients who object that we are switching one substance for another, which to some degree is true, I try to focus on the outcomes.

Yes, we may be switching one medication, one substance for another, but it's with appropriate supervision. And SUBLOCADE is shown to decrease the behavioral symptoms of opioid use disorder. So, I really try to emphasis that. I remind my patients that it's not just about “do you have a substance in your body?”

[00:04:02] But it's really about “how are you doing from a clinical perspective, from a behavioral perspective? How is your life going? How are you feeling overall?”

Dr. Paolo Mannelli: In my experience, the patients who ask for SUBLOCADE are the ones who are better informed. They are coming in with information about the efficacy and asking for more details. The involuntary patients are, at times, coming from a lack of real knowledge of a medication. This is where I, as a provider, intervene and fill the knowledge gap. I try to help them understand how SUBLOCADE is useful and what its benefits are. In some situations, the patients I see are not given a real alternative, when they get out of jail for instance. In some programs they are offered the injection, period.

[00:05:00] It's important to educate patients about treatment options, including patients in the ED or who are homeless. For these patients, even if they have already received the first injection, I believe they should be educated about its use, mechanism, goals, and advantages. This is likely to make the acceptance of the second injection easier in changing involuntary patients into voluntary ones. In response to a drug-for-drug objection, I try to explain to my patients that SUBLOCADE might be a good option for them. They should also be educated about the risks. The study of behavioral pharmacology has shown that the abuse liability of the drug is directly proportional to its short effects. It goes up fast, then it goes down fast. And when those using opioids feel down, their brain needs more drug to feel good again.

[00:06:01] The steady drug levels of a long-acting medication like SUBLOCADE can help break that cycle.

Dr. Arwen Podesta: Voluntary versus involuntary patients, we need to kind of delineate what that means. I work with people in the criminal justice system. And so, those are sometimes considered involuntary patients, as in it's dictated that they get treatment. Of course, a judge or the justice system cannot direct the medication for the patient. But they can mandate treatment, as in medication plus individual and group therapy. I find that, in my drug court patients who might be reticent or resistant to starting medication or to even being in treatment, ultimately, they have the same positive outcomes as my voluntary patients that bring themselves into treatment. Group therapy, in my opinion, is critical in that regard because that patient-to-patient interaction, one patient telling another about their success, really makes a big difference.

[00:07:01] The drug-for-drug mindset is pretty common, especially with those with addiction in the criminal justice system, meaning that people think that taking a medication for treatment of a drug problem is trading one drug for another. So, that said, I do have to spend a lot of time educating patients and staff on motivational interviewing and neurobiology. It can be challenging for me because patients have their own mindset, so it takes a fair amount of motivational interviewing skills and time to really see the patient make progress in choosing a medication for opioid use disorder that's right for them.

[No dictation] [00:07:36 – 00:08:07]

[00:08:00]

[End of Audio]

Duration: 8 minutes

SUBLOCADE resource videos

SUBLOCADE administration video

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Learn how to administer the SUBLOCADE buprenorphine injection

SUBLOCADE® (buprenorphine extended-release) 100 mg and 300 mg. For abdominal subcutaneous injection only.

Instructions for Use

INDICATION

SUBLOCADE 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

  • 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 thrombo-embolic 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 the REMS requirements.

SUBLOCADE is for abdominal subcutaneous injection only and should be prepared and administered by a healthcare provider only. Do not inject intravenously, intramuscularly, or intradermally.

When using SUBLOCADE, it is important to read all instructions carefully before handling the product. The following measures are important to help ensure proper administration of SUBLOCADE:

  • As a universal precaution, always wear gloves.
  • Remove SUBLOCADE from the refrigerator prior to administration. The product requires at least 15 minutes to reach room temperature. Do not open the foil pouch until the patient has arrived for his or her injection.
  • Discard SUBLOCADE if left at room temperature for longer than 7 days.
  • Do not attach the needle until time of administration.

Step 1. Getting Ready

To prepare SUBLOCADE for use, first remove the foil pouch and safety needle from the carton. Open the pouch and remove the syringe. Discard the oxygen absorber pack. It is not needed.

Step 2. Check the Liquid Clarity

Before administering SUBLOCADE, check that the medication does not contain contaminants or particles. SUBLOCADE ranges from colorless to yellow to amber. Variations of color within this range do not affect the potency of the product.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Step 3. Attach the Safety Needle

When you are ready to administer SUBLOCADE, you will need to attach the safety needle. To do that, remove the cap from the syringe and remove the safety needle supplied in the carton from its sterile package.

Gently twist the needle clockwise until it is tight and firmly attached.

Do NOT remove the plastic cover from the needle.

Step 4. Prepare the Abdominal Injection Site

Choose an injection site on the abdomen between the transpyloric and transtubercular planes with adequate subcutaneous tissue that is free of skin conditions such as nodules, lesions, and excessive pigment. It is recommended that the patient is in the supine position.

[Onscreen text and images]

Male torso shows perforated line 2 inches above (Transpyloric plane), and 2 inches below (Transtubercular plane) the navel (belly button)

[Onscreen text]

Ensure subcutaneous tissue is free of skin conditions

Do not inject into an area where the skin is irritated, reddened, bruised, infected, or scarred in any way.

[Onscreen text]

Do not inject where the skin is:

  • Irritated
  • Reddened
  • Bruised
  • Infected
  • Scarred

Clean the injection site well with an alcohol swab. To avoid irritation, rotate injection sites following a pattern similar to what is shown onscreen.

[Onscreen text]

Rotate injection sites

[Image description]

Illustration shows pattern of recommended injection sites, including 4 points located around the navel. These points are in the upper left, upper right, lower left, and lower right corners of the abdomen, approximately 2 inches from the navel.

Record the location of the injection to ensure that a different site is used at the time of the next injection.

[Onscreen text]

Record injection sites

Step 5. Remove Excess Air From the Syringe

Prior to injection, remove excess air from the syringe. To do that, hold the syringe upright for several seconds to allow air bubbles to rise. Because of the viscous nature of the medication, bubbles will not rise as quickly as those in an aqueous solution.

Once bubbles have risen to the top of the medication, remove the needle cover and slowly depress the plunger to push out the excess air from the syringe. Small bubbles may remain in the medication. Large air gaps, however, can be minimized by pulling back on the plunger rod to pop air bubbles prior to expelling the air very slowly. Air should be expelled very carefully to avoid loss of medication. If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.

Step 6. Pinch the Injection Site

To prepare for injecting the medication, pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle. Lift the adipose tissue from the underlying muscle to prevent accidental intramuscular injection.

Step 7. Inject the Medication

SUBLOCADE is for subcutaneous injection only. Do not inject intravenously, intramuscularly, or intradermally.

To inject the medication, insert the needle fully into the abdominal subcutaneous tissue. The actual angle of injection will depend on the amount of subcutaneous tissue present. Use a slow, steady push to inject the medication. Continue pushing until all of the medication has been administered.

Step 8. Withdraw the Needle

After all of the medication has been administered, withdraw the needle at the same angle used for insertion and release the pinched skin.

Do not rub the injection area after the injection. There may be a small amount of blood or fluid at the injection site; wipe with a cotton ball or gauze before applying a gauze pad or bandage using minimal pressure.

Step 9. Lock the Needle Guard and Discard the Syringe

Lock the needle guard into place by pushing it against a hard surface, such as a table. Dispose of all syringe components in a secure sharps disposal container.

Step 10. Instruct the Patient

Advise the patient that they may have a lump for several weeks that will decrease in size over time.

Instruct the patient not to rub or massage the injection site and be aware of the placement of any belts or clothing waistbands.

[Onscreen text]

  • Do not rub or massage the injection site
  • Be aware of the placement of any belts or clothing waistbands
more about dosing

OUD=opioid use disorder.

Helpful downloadable materials

Your patients

Person using laptop with text bubbles icon

SUBLOCADE Patient Education Brochure

Download English
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SUBLOCADE Medication Guide

Your practice

Document with pages icon

SUBLOCADE Prescribing Information

Booklet with text bubble icon

SUBLOCADE Dosing & Administration Guide

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

  • 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 thrombo-embolic 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 the REMS requirements.

CONTRAINDICATIONS: SUBLOCADE should not be administered to patients who are hypersensitive to buprenorphine or any component of Indivior's proprietary buprenorphine gel depot 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 a pregnancy or side effects associated with taking SUBLOCADE or any safety related information, product complaint, request for medical information, or product query, please contact PatientSafetyNA@indivior.com or 1-877-782-6966.

See full Prescribing Information, including BOXED WARNING, and Medication Guide. For REMS information visit www.sublocadeREMS.com.

Reference: 1. SUBLOCADE [prescribing information]. North Chesterfield, VA: Indivior Inc.

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SUBLOCADE® and INSUPPORT® are registered trademarks of Indivior UK Limited.

SUBLOCADE is manufactured by Curia Global Inc., Albany, NY 12203.

© 2023 Indivior UK Limited | INDIVIOR® is a registered trademark of Indivior UK Limited | All Rights Reserved.

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Intended for US audiences.