Setting patient expectations and goals when initiating SUBLOCADE® (buprenorphine extended-release), 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 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 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 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.
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.”
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. 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.
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.
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.
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. 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.
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.
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.
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]
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-01293 EXPIRY April 2025