INDICATIONS AND USAGE

SUBLOCADE™ (buprenorphine extended-release) is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal 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.

MORE SAFETY INFORMATION

INDIVIOR INC. WEBSITE PRIVACY POLICY

Indivior Inc., a subsidiary of Indivior PLC, has outlined below its responsibility to its users and their privacy below.

If you have an unresolved privacy or data use concern that we have not addressed satisfactorily, please contact Indivior Inc.

1. What this Privacy Policy Covers

Indivior Inc. ("Indivior," "we," "us," and/or "our,") respects the privacy of every individual ("You," or individually each a "User" and collectively "Users") who visits and uses sublocade.com and sublocade.com/hcp and their associated products and services or responds to our interactive advertisements (the "Site"). This Privacy Policy outlines the information provided to us by you as a User of the site or that Indivior will collect and how we will use, and may, in some instances, share that information. It also describes the choices available to you regarding our use of your personal information and how you can access and update this information.

This Privacy Policy is part of and incorporated into the Terms of Use, found at sublocade.com/hcp/terms-of-use which is a legally binding agreement between Indivior and you.

Please read this policy carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Site. BY ACCESSING, BROWSING, OR USING THE SITE, YOU ACKNOWLEDGE THAT YOU HAVE RECEIVED, READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THE FOLLOWING PRIVACY POLICY, AND ANY UPDATES TO IT.

YOU FURTHERMORE ACKNOWLEDGE AND AGREE THAT INDIVIOR IS NOT A MEDICAL PRACTICE AND DOES NOT PROVIDE MEDICAL ADVICE.

When we use these capitalized terms, they have the following definitions:

"Disclose" (and variations such as "Disclosure") means any and all of the following: using, accessing (or barring access), processing, fulfilling, disclosing, receiving, displaying, sharing, making available, transferring, storing, selling, leasing, licensing, retaining, deleting or destroying, combining, investigating, verifying, proving, enforcing and otherwise dealing with, voluntarily or involuntarily, Personal Information.

"Personal information," "personal information" or "PI" means information that we are required by law to protect and that: (a) personally identifies you, or (b) to the extent required by law, reasonably can be used specifically to identify you or your computing device.

2. Personal Information

Indivior will collect certain personal information that you provide to us voluntarily. For example, and not by limitation, we may collect personal information when you fill out a questionnaire; sign up for a survey or otherwise interact with us. Such information may include, but may not be limited to, your name, address, phone number and email address. In addition to providing you with the service or information you request on our Site, your PI may also be used to help us track the way you use our Site and our products.

Healthcare providers who register to use services provided on this Site may need to furnish PI about another individual (e.g., a patient). We will use the PI you submit to provide the services you request consistent with this Privacy Policy. If you are a healthcare provider and you disclose PI to us, you and you alone bear the sole obligation and responsibility of obtaining any patient consents and authorizations for such disclosures that may be required under federal and state law.

When you access and use our web site (sublocade.com/hcp) through your mobile device, we automatically collect information on the type of device you use, operating system version, and the device identifier.

a. Future Communications from Indivior Inc.

When you provide Personal Information to us, we may ask if you want to receive future communication from us, such as newsletters, email or other information. You can choose not to receive this communication, if you wish, and you may opt-out by clicking on the link on the bottom of an email you received or by clicking here.

We may also send you service-related email announcements on rare occasions when it is necessary to do so. For instance, if our service is temporarily suspended for maintenance, we might send you an email. You do not have an option to opt out of these emails, which are not promotional in nature.

b. What Indivior Inc. Tends to do With Personal Information Collected

We may combine the information you provide with information that we collect separately, including information you have provided to other organizations as well as public information (USPS, Yellow Pages, etc.). All of this will help us, for instance, better design our products, Sites and advertisements. In order to do this, we may also share your information with companies who carry out work for us. Information may be shared with service providers who provide services for or administer activities on behalf of Indivior. Information you submit to one or more of the Indivior brands may be shared with another of the Indivior brands. Your Personal Information may also be shared with service providers who warehouse product, perform order fulfillment or provide hosting services. These companies have agreed to only use your information in the way we tell them and to have procedures in place to protect the information.

We will share your Personal Information with third parties only in the ways that are described in this Privacy Policy. We do not sell your Personal Information to third parties.

In the event Indivior, or its assets, is bought or sold, Personal Information may be included among the transferred business assets. In this case, a prominent notice on our Site of any change in ownership or uses of your Personal Information, as well as any choices you may have regarding your Personal Information will be provided.

Indivior may disclose specific Personal Information if it determines that such disclosure is necessary to comply with the law, such as to comply with a subpoena or to protect the safety of the public. When we believe in good faith that disclosure is necessary to protect our rights, protect your safety or the safety of others, or respond to a government request, we may disclose Personal Information. This includes exchanging information with other companies and organizations for fraud protection and credit risk reduction.

If we intend to share your information with an unaffiliated company, other than as set out above, we will contact you first and give you the opportunity to remove your information from our database.

3. Children's Privacy

This Site is not intended to be used by anyone under the age of 18 and we do not want to collect information from anyone under 18. If a child's parent or a guardian believes their child may have provided PI to us, write us at our Legal Notices Address and we will use commercially reasonable efforts to delete that PI, subject to applicable law and this Privacy Policy.

4. Linked Sites

The Indivior Site(s) may contain links to other websites. The Privacy Policies at these other websites may be different from this one. When leaving an Indivior site, you should refer to the Privacy Policy of both our Site(s) and the third-party website(s), as they may differ. You agree, however, that if they provide PI back to us, we may apply this Privacy Policy to what we receive.

5. Cookies and Other Tracking Technologies

Technologies such as cookies, tags and scripts are used by Indivior Inc. and our marketing agency partners, affiliates, or analytics or service providers. These technologies are used in analyzing trends, administering the website, tracking users’ movements around the website and to gather demographic information about our user base as a whole. We may receive reports based on the use of these technologies by these companies on an individual as well as aggregated basis.

We use cookies for purposes such as streamlining user experience, remembering users’ settings, and for authentication. Users can control the use of cookies at the individual browser level. If you reject cookies, you may still use our website, but your ability to use some features or areas of our website may be limited.

• Log Files

As is true of most websites, we gather certain information automatically and store it in log files. This information may include internet protocol (IP) addresses, browser type, internet service provider (ISP), referring/exit pages, operating system, date/time stamp, and/or clickstream data. We may combine this automatically collected log information with other information we collect about you. We may do this to improve our services and communications, or to improve site functionality.

Mobile Analytics

We use mobile analytics software to allow us to better understand the functionality of our mobile website when you access it through your mobile device. This software may record information such as how often you use the mobile site, the events that occur within the mobile site, aggregated usage, performance data, and where the mobile site was accessed from. We do not link the information we store within the analytics software to any personal information you submit within the mobile site.

We partner with a third-party ad network to either display advertising on our Site or to manage our advertising on other websites. Our ad network partner uses cookies and web beacons to collect non-personal information about your activities on this Site and other websites to provide you targeted advertising based upon your interests. If you wish to not have this information used for the purpose of serving you targeted ads, you may opt-out by clicking here (or if located in the European Union click here). Please note this does not opt you out of being served advertising. You will continue to receive non-sponsored ads.

6. How Your Information is Protected

Indivior uses industry standard security techniques to help protect against the loss, misuse or alteration of information collected from you at an Indivior Site. When you transmit Personal Information, that information is stored on servers that Indivior has attempted to secure from unauthorized access or intrusion. Of course, the Indivior Sites cannot be and are not responsible for unauthorized access to information by hackers who have obtained such access through illegal measures.

Unfortunately, the transmission of information via the internet is not completely secure. Although we will do our best to protect your Personal Information, we cannot guarantee the security of the Personal Information you transmit to our Site; any transmission is at your own risk.

While we cannot guarantee that loss, misuse or alteration to data will not occur, once we have received your information, we will make reasonable efforts to prevent such occurrences.

7. Who to Contact

If you have submitted Personal Information through an Indivior Site or interactive advertisement, and would like that information modified, changed or deleted from our records, please click here to provide us with your request and the email address you provided. We will respond to your inquiry within 30 days.

If you think we are in default under this Privacy Policy, you may contact us at Our Legal Notices Address:

Indivior Inc.
10710 Midlothian Turnpike
North Chesterfield, VA 23235
Attn: Legal Department
Email: Indivior_Privacy@Indivior.com 

8. How You Can Update, Change or Delete Your Information

If at any time you want to update, change or delete your information, you may log in to the Site where you have your information and make those changes on your profile page. If you do not want your PI collected, please do not submit it to us. If you have received an email and you would like to opt-out of receiving future emails, please click on the opt-out link at the bottom of that email or please click here to opt-out.

Please note that we do not maintain all PI in a form that can be accessed or updated by you and some PI may not be changed (e.g., payment records). Accordingly and subject to applicable law, we will determine what may be accessed and how; we may also keep a record of changes (including deletions) and disclose them for lawful purposes.

We keep PI for as long as your account is active or as needed to provide you services and reserve the right to retain it to the full extent not prohibited by law (e.g., for the length of a statute of limitations). We may discard PI at our discretion, so you should retain your own records. Often it is not feasible or advisable to actually discard PI (such as commingled PI), so we reserve the right to retain and treat it as inactive or discarded (such as removing traditional "pointers" to it).

You may make a request for us to update eligible PI by writing to us at our Legal Notice Address. If applicable law requires us to accept requests by other means, use our address to obtain information about the other means. We will honor requests if required by law or if we determine in our sole discretion to do so. We may comply with qualified requests by supplying a copy or access to the relevant PI within a reasonable time, but no less time than is needed by us or others for processing or altering databases in the ordinary course of business. If we have a duty to require third-parties to delete or cease using PI, we may satisfy it by sending them notice to do so without further action (except as expressly required by law).

9. Special Note to International Users

The Site is hosted in the United States of America. If you are a User that is a resident of another country, or are accessing the Site from outside of the United States of America, please note that you are transferring your data to the United States of America which does not have the same data protection laws as the European Union and other regions, and by providing your data you explicitly consent to (i) the use of your data for the uses identified above in accordance with the Privacy Policy and (ii) the transfer of your data, including Personal Information, to the United States of America as indicated above.

10. Revisions to this Privacy Policy

We may modify this Privacy Policy to reflect the changes to our information practices and you should therefore periodically visit this page to be sure that you have read and agree with our most current Privacy Policy. If we make any material changes we will notify you on this Site prior to the change becoming effective.

This Privacy Policy was last revised on February 20, 2018 and is effective as of that date.

IMPORTANT SAFETY INFORMATION AND BOXED WARNING
INDICATIONS AND USAGE

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 indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal 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.

Prescription use of this product is limited under the Drug Addiction Treatment Act.

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 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).

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.

Use in Patients at Risk for Arrhythmia: Buprenorphine has been observed to prolong the QTc interval in some patients participating in clinical trials. Avoid use of buprenorphine in patients with a history of Long QT Syndrome or an immediate family member with this condition or those taking Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval.

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.

INDICATIONS AND USAGE

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal 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.

For more information about SUBLOCADE, see the full Prescribing Information including BOXED WARNING, and Medication Guide. For REMS information visit www.sublocadeREMS.com.