Help Transform Recovery1‑3
Help patients select appropriate treatment for their unique needs
Determining well‑suited treatments for patients warrants consideration of both clinical factors and individual challenges2,4,5
Help patients select appropriate treatment for their unique needs
Determining well‑suited treatments for patients warrants consideration of both clinical factors and individual challenges2,4,5
With fentanyl today, patients may want stable medication delivery all month from Day 11,6
Meet Adam -
Fearful of Uncertainty
Not actual patient.
Clinical and
patient‑specific factors:
- Severe OUD
- Lifetime opioid use is 10 years
- Works in construction
- History of relapse
- Currently taking TM BUP, but feels vulnerable to the daily ups and downs in medication levels
- Has been through the criminal justice system and ordered to outpatient treatment program including MOUD
- Recurring urine drug screens positive for opioids (eg, heroin or fentanyl)
Personal challenges
and goals:
- Because of the highly addictive nature of fentanyl today, is fearful of return to use and desires stable medication delivery all month as quickly as possible starting from the first dose1,6-8
- Wants to continue to work on reducing high-risk behaviors1,9,10
- To continue on road to recovery, looking for treatment that helps protect him from opioid-rewarding effects until his next dose1,3,9
- Main goal for treatment is to reduce illicit opioid use9,11
Not actual patient.
MOUD=medication for opioid use disorder; OUD=opioid use disorder; TM BUP=transmucosal buprenorphine.
Why Adam chose SUBLOCADE® with his provider
- Helps reduce illicit opioid use1
- Delivers continuous and lasting levels of buprenorphine all month that help block opioid‑rewarding effects1
- Helps interrupt the cycle of addiction1
- SUBLOCADE can be started on Day 11
Patients who struggle with shame about perceived stigma toward OUD diagnosis and medication often value discreet options12,13
Meet Chris -
Troubled by Stigma
Not actual patient.
Clinical and
patient‑specific factors:
- Moderate OUD
- Lifetime opioid use is 6 years
- Unemployed and newly single
- Took daily buprenorphine for several months
- Completed 2 rounds of outpatient treatment
Personal challenges
and goals:
- Is troubled by stigma surrounding OUD diagnosis and medication and would like to keep treatment private from others, including some family12,13
- Drawn to structured, once-monthly treatment with an LAI for its discretion1,13
- Recognizes there is no magic solution for OUD and is committed to long-term recovery4
- Main goal in recovery is to work on self-improvement4
Not actual patient.
LAI=long-acting injectable.
Why Chris chose SUBLOCADE with his provider
- Administered discreetly by a healthcare provider1,13
- Once‑monthly treatment1
- Long-acting treatment supports Chris' efforts to focus less on stigma and more on rebuilding in recovery1,4,13
Patients can feel burdened by daily drug-taking and want to focus instead on lifestyle changes5,13,14
Meet Denise -
Burdened by Daily Reminders
Not actual patient.
Clinical and
patient‑specific factors:
- Moderate OUD
- Lifetime opioid use is 11 years
- Retired military veteran
- Works part-time at a supermarket, is married, and enjoys travel with family
- Though initially fearful of injections, became open to LAIs after using daily oral buprenorphine for several months
- Went through inpatient detox and rehabilitation
Personal challenges
and goals:
- Feels burdened by daily medication as it is a daily reminder of her addiction5,10,13
- Worried about being in control of taking daily medication and would prefer an option administered by her doctor1,7,15
- Main goal in addition to symptom management is to focus on lifestyle changes2,4
Not actual patient.
Why Denise chose SUBLOCADE with her provider
- Delivers consistent levels of medication1
- Once-monthly treatment1
- Only administered by a healthcare provider1
- Doesn't remind her of daily drug-taking ritual7,13
- Reassured that she has a choice of 4 injection site options from the first subcutaneous injection that should be rotated1
INDICATION
SUBLOCADE® is for moderate to severe opioid use disorder in those who have initiated treatment with a single dose of transmucosal buprenorphine or are already being treated with buprenorphine as part of a complete treatment plan that includes counseling and psychosocial support.
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 the 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 if administered before the effects have subsided, at least 6 hours for short-acting opioids and 24 hours for long-acting opioids. Verify that patients have tolerated transmucosal buprenorphine before administering the first injection of 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.
P-BAG-US-01602 Feb 2025