Initiating SUBLOCADE® (buprenorphine extended-release) 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 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. 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.
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.
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.
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.”
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.”
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.
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]
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.
© 2023 Indivior UK Limited | All rights reserved.
P-BAG-US-01291 EXPIRY April 2025