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® (buprenorphine extended-release) is for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product for a minimum of seven days. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
SUBLOCADE has a Boxed Warning:
Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids, and may cause occlusion, local tissue damage, and thromboembolic events including life-threatening pulmonary emboli if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with REMS requirements.
See additional Important Safety Information and full Prescribing Information including BOXED WARNING, and medication guide at sublocadehcp.com.
This HCP experience video contains the personal views, opinions, and experiences of the featured physicians. Each physician has been compensated by Indivior® for their participation in the video’s creation. HCPs should exercise their own independent judgement in deciding how to clinically treat the patients they see.
Dr. 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.
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.
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.
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.
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.
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.
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.
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.
Without MOUDs, some patients may be at increased risk for returning to opioid use.
[End of Audio]
SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use, CIII
HCP Indication and Important Safety Information
INDICATION
SUBLOCADE® (buprenorphine extended-release) injection, for subcutaneous use, CIII, is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support.
|
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.
DRUG INTERACTIONS
CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing.
Serotonergic Drugs: If concomitant use with serotonergic drugs is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug.
Consult the full Prescribing Information for SUBLOCADE for more information on potentially significant drug interactions.
USE IN SPECIFIC POPULATIONS
Pregnancy: Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.
Lactation: Buprenorphine passes into the mother’s milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.
Fertility: Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Geriatric Patients: Monitor geriatric patients receiving SUBLOCADE for sedation or respiratory depression.
To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966.
See full Prescribing Information, including BOXED WARNING, and Medication Guide, or for more information about SUBLOCADE, visit www.sublocadehcp.com. For REMS information visit www.sublocadeREMS.com.
SUBLOCADE® and INDIVIOR® are registered trademarks of Indivior UK Limited.
© 2023 Indivior UK Limited | All rights reserved.
P-BAG-US-01295 EXPIRY April 2025