INDICATION: SUBLOCADE (buprenorphine extended-release) injection, for subcutaneous use (CIII) is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who have received an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days. SUBLOCADE is part of a complete treatment plan that should include counseling.

Terms of Use

SUBLOCADE™ is a trademark of Indivior UK Ltd. (“Indivior,” “we,” or “us”) or its affiliated companies.

YOUR ACCESS TO AND USE OF THIS SITE, WWW.SUBLOCADE.COM (THE “SITE”), ARE SUBJECT TO THE FOLLOWING TERMS OF USE (the “Terms”). BY VIEWING THIS SITE, YOU AGREE TO THESE TERMS. IF YOU DO NOT AGREE TO ITS TERMS, DO NOT VIEW THIS SITE.

1. Modification of the terms

Indivior reserves the right to change these Terms from time to time as it deems necessary, and will post such changes and their effective date within the current terms of use on this Site. Any changes to these Terms will be effective after the date on which the revised Terms are posted.

2. Eligibility

In order to use the Site, you must be 18 years of age and fully able and competent to enter into the terms, conditions, obligations, affirmations, representations and warranties set forth in the Terms and to abide by and comply with the Terms. You represent that you meet the eligibility requirements in this Section and that you are over the age of 18, as the Site is not intended for use by anyone under 18.

3. Privacy Notice

Your privacy is important to Indivior. Indivior's Privacy Policy is hereby incorporated into the Terms by reference. All information Indivior collects on this Site is subject to our Privacy Policy located at http://www.sublocade.com/privacy-policy. Please read it carefully for information relating to Indivior's collection, use, and disclosure of your personal information.

4. Applicable law and venue

These Terms are governed by the laws of the Commonwealth of Virginia, without regard to its rules regarding conflicts of law.

By using this Site, you agree that all litigation arising from or related to this Site shall be instituted and maintained only in the Circuit Court of the County of Henrico, Virginia, or in the United States District Court for the Eastern District of Virginia, Richmond Division, and you irrevocably waive any objection that you may have at any time to the laying of venue in any suit, action or proceeding arising out of or related hereto brought in any such court, irrevocably waive any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum, and irrevocably waive the right to object, with respect to any such suit, action or proceeding brought in any such court, that such court does not have jurisdiction over you.

5. Site access

USE OF THIS SITE IS NOT AUTHORIZED IN ANY JURISDICTION THAT DOES NOT GIVE EFFECT TO ALL PROVISIONS OF THESE TERMS, INCLUDING WITHOUT LIMITATION, THIS PARAGRAPH. THESE TERMS APPLY ONLY TO YOUR USE OF THIS SPECIFIC SITE. INDIVIOR OPERATES OTHER WEBSITES THAT ARE COVERED BY THEIR OWN TERMS OF USE AS SPECIFIED IN THOSE WEBSITES.

You may browse this Site for personal information. However, you may not copy, distribute, modify, transmit or revise the contents of this Site without written permission of Indivior. Neither title nor intellectual property rights are transferred to you or any third party through the use or access to this Site; rather, all rights, title, and interest in and to all aspects of this site remain the sole property of Indivior or its affiliates.

6. No warranties

This Site, its Content and access are provided on an “AS IS” basis. INDIVIOR, AND ITS AFFILIATES, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD-PARTIES' RIGHTS, TITLE, OR FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTIES ARISING BY COURSE OF DEALING OR CUSTOM OF TRADE. Specifically, Indivior and its affiliates make no representations or warranties regarding the (i) accuracy, completeness, currency or timeliness of the Content, (ii) links provided on or through the use of this Site or (iii) the quality and security of the Site, or inability to access the Content or Site, including whether they will be free of viruses, unauthorized code or other harmful components.

7. Medical information

The Content is offered for informational and educational purposes only, and is not intended to be a substitute for medical advice, diagnosis or treatment. We do not offer or give medical advice, nor do we provide medical or diagnostic services. Use of this Site does not create a doctor/patient between you and Indivior or its affiliates. Instead, the Content is intended to support, not replace, the relationship that exists between you and your physician. You should not act upon this information without seeking professional advice and counsel.

Any statements made in this Site about products have not been evaluated by the United States Food and Drug Administration. They are not intended to diagnose, treat, cure or prevent any condition or disease.

We do not endorse any specific tests, products, procedures, opinions, or other information that may be mentioned or described in this Site. If you rely on any Content obtained by you on or through this Site, you do so solely at your own risk. You are solely responsible for compliance with the laws and regulations applicable to your place or country of residence and accessing this Site from any country where its content does not comply with its laws and regulations is prohibited.

8. Limitation of liability, Damages

YOU AGREE THAT INDIVIOR AND ITS AFFILIATES SHALL NOT BE LIABLE TO YOU OR ANYONE ELSE FOR ANY LOSS OR INJURY CAUSED IN WHOLE OR IN PART BY RELYING UPON, USING, OR INTERPRETING THE CONTENT OR ANY OTHER INFORMATION OBTAINED THROUGH USE OF THIS SITE. IN NO EVENT WILL INDIVIOR OR ITS AFFILIATES BE LIABLE TO YOU OR ANYONE ELSE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR EXEMPLARY DAMAGES OR LOST PROFITS ARISING OUT OF THE USE OR INABILITY TO USE THE CONTENT, THE SITE OR ANY OTHER INFORMATION OBTAINED THROUGH THE SITE, EVEN IF INDIVIOR, ITS AFFILIATES, ITS LICENSORS, AGENTS OR REPRESENTATIVES KNOW OR HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE EXCLUDED DAMAGES INCLUDE, BUT ARE NOT LIMITED TO, MEDICAL, LEGAL AND ACCOUNTING MALPRACTICE DAMAGE CLAIMS OR AWARDS, PAIN AND SUFFERING, PERSONAL INJURY/WRONGFUL DEATH, LOSS OF INCOME, LOSS OF CONSORTIUM, BUSINESS INTERRUPTION, MEDICAL BILLS, DAMAGES FOR LOSS OF DATA, LOSS OF PROGRAMS, AND/OR COST OF PROCUREMENT OF SUBSTITUTE SERVICES OR SERVICE INTERRUPTIONS. INDIVIOR'S AND ITS AFFILIATES CUMULATIVE LIABILITY TO YOU OR ANY OTHER PARTY FOR ANY LOSS OR DAMAGES RESULTING FROM ANY CLAIMS, DEMANDS, OR ACTIONS ARISING OUT OF OR RELATING TO THE SITE, THE CONTENT OR THESE TERMS OF USE SHALL NOT EXCEED FIVE DOLLARS ($5.00). SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL DAMAGES, OR LIMITATIONS UPON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. IN NO EVENT SHALL INDIVIOR OR ITS AFFILIATES BE LIABLE FOR ANY PERSONAL INJURY, INCLUDING DEATH, CAUSED BY YOUR USE OR MISUSE OF THIS SITE OR THE CONTENT. Any claims made by you in connection with your use of this Site or the Content must be brought within one (1) year of the date on which the event giving rise to such action occurred. All remedies set forth in these Terms are exclusive and are limited to those expressly provided for in these Terms.

9. Links and third party websites

Any link (including a hyperlink, button or referral device of any kind) used on this Site is provided for your use and convenience. The appearance of a link on this Site does not constitute an endorsement, recommendation or certification by us, nor should the presence of a link in any way be construed as a suggestion that any third-party website has any relationship with us. We do not endorse the content on any third-party websites. We are not responsible for the content of linked third-party websites or third-party advertisements, and do not make any representations regarding their content or accuracy. We do not knowingly link to websites that may infringe on valid and existing trademarks, service marks, copyrights or patents. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such websites.

10. Your use of the Site

Neither Indivior nor its affiliates is under any obligation to respond to messages posted to this Site, nor need we provide any compensation for any such communication. If you post any information or material to this Site you are responsible for such information or material and the consequences of their posting. If you choose to post material, you agree to do so solely for lawful purposes and in compliance with all applicable laws. You expressly agree that we have no responsibility for or control over the information, creations, data or material you may post to this Site. We make no representation that your use of this Site will comply with applicable laws or that they were designed to comply with the applicable laws. For example, many states regulate physician advertising and you are responsible for ensuring that your use of the Site complies with laws applicable to you. You also expressly agree that you will not post any material that: (1) is defamatory, libelous, abusive, or obscene, including, without limitation, material which encourages conduct that would constitute a criminal offense, give rise to civil liability or otherwise violate any applicable local, state, federal, or international law; (2) infringes on the copyright or any other proprietary right of a third party; (3) would invade the privacy of any other person; (4) is intended to advertise to or solicit others without our express permission; (5) constitutes charity solicitations, chain letters or pyramid schemes; (6) contains a virus, worm, Trojan horse, time bomb, or any other harmful program or component; or (7) does not generally pertain to the designated topic or theme of the Site. You further expressly agree that you will not: (a) after receiving warning, continue to post material which we have advised you not to post; (b) create a false identity or forged e-mail address or header, or otherwise attempt to mislead others as to the identity of the sender or the origin of the message; (c) post, generate or disseminate so-called “spam” or mass-mailings; (d) harvest or otherwise collect information about others, including email addresses, without their consent; (e) interfere with or disrupt networks connected to the Site, or used for purposes of delivering the Content (or violate the regulations, policies or procedures of such networks); (f) attempt to gain unauthorized access to restricted areas of the Site, other accounts, computer systems or networks connected to the Site, through password mining or any other means; or (g) interfere with another user's use and enjoyment of the Site.

11. No monitoring

We do not and are not responsible for screening or monitoring material posted by you or any other person or entity. If notified by one of our Users of any material that is alleged not to conform to the terms of these Terms of Use, we may investigate the allegation and determine in our sole discretion to remove or request the removal of the material. We reserve the right to remove material that is abusive, illegal, disruptive, or that otherwise fails to conform to these Terms of Use. We reserve the right to edit or delete any material posted on our Site, regardless of whether such material violates these standards for content. We have no liability or responsibility to you or any other person or entity for performance or nonperformance of the screening activities set forth above.

We further do not represent, warrant or guarantee the truthfulness, accuracy, or reliability of any of the material posted by others on the Site. We also do not endorse any opinions expressed by others on the Site. YOU ACKNOWLEDGE THAT ANY RELIANCE ON CONTENT POSTED BY OTHERS ON THE SITE, AND YOUR USE OF THAT CONTENT, IS AT YOUR OWN RISK.

12. Intellectual property rights

You hereby grant to Indivior a non-exclusive, worldwide, royalty-free, perpetual license, with right to sublicense, to reproduce, distribute, transmit, create derivative works of, publicly display and publicly perform and otherwise exploit any materials and other information you submit to the Site by all means and in any media now known or hereafter developed for any use or purpose.

13. Digital Millennium Copyright Act Compliance.

If You are a copyright owner or an agent thereof, and believe that any third party content on the Site infringes upon Your copyrights, You may submit a notification pursuant to the Digital Millennium Copyright Act (“DMCA”) by providing our Copyright Agent with the following information in writing (see 17 U.S.C. § 512(c)(3) for further detail).

(i) A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;

(ii) Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works on the Site are covered by a single notification, a representative list of such works from the Site;

(iii) Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit Indivior to locate the material;

(iv) Information reasonably sufficient to permit Indivior to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted;

(v) A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law; and

(vi) A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.

Indivior's designated Copyright Agent to receive notifications of claimed infringement is:

Email: CopyrightAgent@Indivior.com
Phone: 804-379-1090
Fax: 804-379-1215

14. Trademark use

Indivior only purports to use names, logos or marks appearing in this site in those territories in which it or its affiliates are entitled to do so, whether by virtue of pending or registered trade marks, licenses, or otherwise. For the avoidance of doubt, Indivior does not purport to use any name, logo or mark in any territory in which it is not so entitled, and will not supply or offer to supply products and/or services bearing any such name, logo or mark into any such territory. The use of these trademarks or any other content on this site, except as provided in these terms of use or in the Site content, is strictly prohibited. All site content is Copyright © 2018 Indivior and/or its subsidiaries and affiliated companies. All rights reserved.

In the event that any or any part of the terms contained in these terms of use shall be determined by any competent authority to be invalid, unlawful or unenforceable to any extent, such term shall to that extent be severed from the remaining terms which shall continue to be valid and enforceable to the fullest extent permitted by law.

15. Assignment and Transfer

We may assign this agreement, in whole or in part, at any time without notice to you. You may not assign this agreement or transfer any rights to use the Site.

16. Contract Interpretation

This is the entire agreement between you and Indivior for your use of the Site. It supersedes any prior agreements between you and Indivior regarding your use of the Site. All parts of this agreement apply to the maximum extent permitted by relevant law. If a court holds that we can't enforce a part of this agreement as written, we may replace those terms with similar terms to the extent enforceable under the relevant law, but the rest of this agreement won't change. The agreement's section titles are for reference only and have no legal effect.

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Please see Full Prescribing Information, including BOXED WARNING and Medication Guide for SUBLOCADE.

Important Safety Information

What is the most important information I should know about SUBLOCADE?

Because of the serious risk of potential harm or death from self-injecting SUBLOCADE into a vein (intravenously), it is only available through a restricted program called the SUBLOCADE REMS Program.

  • SUBLOCADE is not available in retail pharmacies.
  • Your SUBLOCADE injection will only be given to you by a certified healthcare provider.

INDICATION

SUBLOCADE™ (buprenorphine extended-release) injection, for subcutaneous use (CIII) is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who have received an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine at a dose that controls withdrawal symptoms for at least 7 days. SUBLOCADE is part of a complete treatment plan that should include counseling.

In an emergency, you or your family should tell the emergency medical staff that you are physically dependent on an opioid and are being treated with SUBLOCADE.

Buprenorphine, the medicine in SUBLOCADE, can cause serious and life-threatening problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

  • feel faint or dizzy
  • have mental changes such as confusion
  • have slower breathing than you normally have
  • have severe sleepiness
  • have blurred vision
  • have problems with coordination
  • have slurred speech
  • cannot think well or clearly
  • have a high body temperature
  • have slowed reflexes
  • feel agitated
  • have stiff muscles
  • have trouble walking

These can be signs of an overdose or other serious problems.

Death or serious harm, including life-threatening breathing problems, can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, muscle relaxants, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with SUBLOCADE. Tell your healthcare provider if you are taking any of these medicines and if you drink alcohol.

SUBLOCADE is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs.

Death has been reported in those who are not opioid dependent who received buprenorphine sublingually.

Do not use SUBLOCADE if you are allergic to buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® Delivery System, a biodegradable 50:50 poly(DL-lactide-co-glycolide) polymer and a biocompatible solvent, N-methyl-2-pyrrolidone (NMP)).

SUBLOCADE may not be right for you. Before starting SUBLOCADE, tell your healthcare provider about all of your medical conditions, including:

  • Trouble breathing or lung problems
  • An enlarged prostate gland (men)
  • A head injury or brain problem
  • Problems urinating
  • A curve in your spine that affects your breathing (scoliosis)
  • Liver problems
  • Gallbladder problems
  • Adrenal gland problems
  • Addison’s disease
  • Low thyroid hormone levels (hypothyroidism)
  • A history of alcoholism
  • Mental problems such as hallucinations (seeing or hearing things that are not there).
  • Are pregnant or plan to become pregnant. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. If you receive SUBLOCADE while pregnant, your baby may have symptoms of opioid withdrawal at birth.
  • Are breastfeeding or plan to breastfeed. SUBLOCADE can pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with SUBLOCADE. Watch your baby for increased drowsiness and breathing problems.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. SUBLOCADE may affect the way other medicines work and other medicines may affect how SUBLOCADE works. Some medicines may cause serious or life-threatening medical problems when taken with SUBLOCADE. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

The doses of certain medicines may need to be changed if used during treatment with SUBLOCADE. Do not take any medicine during treatment with SUBLOCADE until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines during treatment with SUBLOCADE.

You should not take anxiety medicines or benzodiazepines (such as Valium® or Xanax®), sleeping pills, tranquilizers, muscle relaxants, or sedatives (such as Ambien®), antidepressants, or antihistamines that are not prescribed to you during treatment with SUBLOCADE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death. If a healthcare provider is considering prescribing such a medicine for you, remind the healthcare provider that you are being treated with SUBLOCADE.

You may have detectable levels of SUBLOCADE in your body for a long period after stopping treatment with SUBLOCADE.

What should I avoid while being treated with SUBLOCADE?

  • Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medicine affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few days after your injection and when your dose is changed.
  • Do not drink alcohol during treatment with SUBLOCADE, as this can lead to slowed breathing, drowsiness, slow reaction time, loss of consciousness or even death.

What are the possible side effects of SUBLOCADE?

SUBLOCADE can cause serious side effects, including:

  • Physical dependence and withdrawal. Your body can develop a physical need for SUBLOCADE (dependence). If you stop receiving SUBLOCADE, you could have opioid withdrawal symptoms such as:
    • shaking, goose bumps, muscle aches
    • sweating more than normal
    • feeling hot or cold more than normal
    • runny nose and watery eyes
    • diarrhea or vomiting

    These symptoms may start weeks to months after your last dose of SUBLOCADE.

  • Liver problems. Call your healthcare provider right away if you notice any of these signs of liver problems:
    • your skin or the white part of your eyes turns yellow (jaundice)
    • urine turns dark
    • bowel movements (stools) turn light in color
    • decreased appetite
    • stomach (abdomen) pain or nausea

    Your healthcare provider may do tests before and during treatment with SUBLOCADE to check your liver.

  • Allergic reaction. Call your healthcare provider or get emergency help right away if you get:
    • rash, hives, itching
    • swelling of your face
    • wheezing
    • dizziness, or a decrease in consciousness
  • Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.
  • The most common side effects of SUBLOCADE include:
    • constipation
    • headache
    • nausea
    • injection site itching
    • vomiting
    • increase in liver enzymes
    • tiredness
    • injection site pain
  • Long-term (chronic) use of opioids, including SUBLOCADE, may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBLOCADE, see the full Prescribing Information including BOXED WARNING, and Medication Guide or talk to your healthcare provider. For REMS information visit www.sublocadeREMS.com.

You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.