This website provides information available about a range of topics. Like any printed material, it may become out of date over time. It is important that consumers rely on the advice of a healthcare professional to employ good clinical judgment for the specific conditions of individual patients. This information is not intended to be a substitute for the advice of a healthcare professional, or a recommendation for any particular treatment plan.
CHANGES TO TERMS
We may update these Terms from time to time and may amend them at any time to incorporate additional terms specific to additional features, materials, information, products, opportunities, or services that we may make available on or through the website. All such updates and amendments are effective immediately upon notice thereof, which we may give by any means, including, but not limited to, by posting a revised version of these Terms or other notice on the website. You should view these
Terms often to stay informed of changes that may affect you, as your continued use of the website signifies your continuing consent to be bound by these Terms. We expressly reserve the right to make any changes to these Terms, or to the website and its content, at any time, without prior notice to you.
Your Use of The Website
Intellectual Property Ownership
Except for your Content, all text, content, documents, names, logos, trademarks, service marks, brand identities, characters, trade names, graphics, designs, copyrights, trade dress, or other intellectual property appearing in the website, and the organization, compilation, look and feel, illustrations, artwork, videos, music, software and other works on the website (the “Materials”) are owned by Orexo US, Inc. and its affiliates or used with permission or under license from a third party (hereinafter collectively referred to as the “Owner”) and are protected under copyright, trademark, and other intellectual property and proprietary rights laws. As between Orexo US, Inc. and you, all right, title and interest in and to the Materials will at all times remain with Orexo US, Inc. and/or its Owners. The word “Orexo,” the “Orexo” logo, and other marks, logos, and titles are registered and/or common law trade names, trademarks, or service marks of Orexo US, Inc. All Content is the sole responsibility of the user who provided it and is stored upon Orexo US, Inc.’s servers and/or system solely at the direction of such user. Orexo US, Inc. reserves all other rights. Except as expressly provided herein, nothing on the website shall be construed as conferring any license under Orexo US, Inc.’s and/or its Owner’s intellectual property rights, whether by estoppel, implication, or otherwise. Notwithstanding anything herein to the contrary, Orexo US, Inc. may revoke any of the foregoing rights and/or your access to the website, or any part thereof, including the blocking of your IP Address, at any time without prior notice.
You retain ownership of your Content, and you hereby grant Orexo US, Inc. and its designees a worldwide, non-exclusive, sublicensable (through multiple tiers), assignable, royalty-free, fully paid-up, perpetual, irrevocable right to use, reproduce, distribute (through multiple tiers), create derivative works of, and publicly display and perform (publicly or otherwise) your Content, solely in connection with the website (including without limitation for purposes of promoting the website). Please note that, while you retain ownership of your Content, any template or layout in which you arrange or organize such Content through tools and features made available through the website are not proprietary to you, and can be used by Orexo US, Inc. and others for any purposes. You acknowledge and agree that you have no rights in any such template and/or layout, and such template or layout shall be the sole and exclusive property of Orexo US, Inc. You represent, warrant and covenant that (i) you own or otherwise possess all necessary rights with respect to your Content, and (ii) your Content does not and will not infringe, misappropriate, use or disclose without authorization, or otherwise violate any intellectual property or proprietary right of any third party, and are not unlawful, fraudulent, threatening, abusive, libelous, defamatory, obscene, or otherwise objectionable.
Restrictions on Use
No other use of the website or Materials is authorized. You agree that any copy of the Materials (or any portion of the Materials) that you make must retain all copyright and other proprietary notices contained herein or therein. Framing of the website or website Materials or posting of Materials on other websites is strictly prohibited. The use or misuse of any Materials, except as provided in these Terms or in the Materials, is strictly prohibited. You shall not, without Orexo US, Inc.’s express written consent: (i) distribute text or graphics to others; (ii) copy and retransmit, disseminate, broadcast, circulate, or otherwise distribute the Materials on any other server, or modify or reuse all or part of the Materials on this system or any other system; (iii) use any trade name, trademark, or brand name of Orexo US, Inc. in metatags, keywords and/or hidden text; (iv) copy, distribute, modify, transmit, perform, reuse, repost, or otherwise display the Materials, in whole or in part, for public or commercial purposes or modify, translate, alter, or create any derivative works thereof; (v) create derivative works from the Materials or commercially exploit the Materials, in whole or in part, in any way; (vi) use the website, the Materials, and/or any portion thereof, in any manner that may give a false or misleading impression, attribution, or statement as to Orexo US, Inc., the Owner, or any third party referenced therein; (vii) use the Materials, and/or any services and products on the website or accessible via the website for unlawful purposes only; or (viii) alter, remove or obscure any copyright notice, digital watermarks, proprietary legends or any other notice included in the Materials.
Acceptable Use Restrictions
Your use of the website is conditioned upon your compliance with the following rules (“Acceptable Use Restrictions”):
You shall not upload to, transmit through, or display via the website any Content that: (i) is unlawful, fraudulent, threatening, abusive, libelous, defamatory, obscene or otherwise objectionable, or infringes our or any third party’s intellectual property or other rights; (ii) contains confidential, proprietary, or trade secret information of any third party; (iii) violates the rights of others, including without limitation any privacy rights or rights of publicity; (iv) impersonates any person or entity, falsely states or otherwise misrepresents your affiliation with any person or entity, or uses any fraudulent, misleading or inaccurate email address or other contact information; (v) violates any applicable laws or regulations; (vi) makes any statement, express or implied, that you are endorsed by Orexo US, Inc. or its affiliates; (vii) harms minors in any way, including, but not limited to, by depicting content that violates child pornography laws, child sexual exploitation laws and laws prohibiting the depiction of minors engaged in sexual conduct; (viii) contains any unsolicited promotions, political campaigning, advertising or solicitations; (ix) in our sole judgment is inappropriate or objectionable or which restricts or inhibits any other person from using or enjoying the website, or which may expose Orexo US, Inc., its affiliates, or any of their respective officers, directors, employees, or other users to any harm or liability of any type.
You shall not use the website to engage in any of the following activities: (i) accessing, using, or uploading Content to, or attempting to access, use, or upload Content to another user’s account without permission; or (ii) transmitting, uploading, or downloading, any software or other materials that contain any viruses, worms, trojan horses, defects, date bombs, time bombs, or other items of a destructive nature.
You shall not: (i) modify, adapt, sublicense, translate, sell, reverse engineer, decompile, or disassemble any portion of the website; (ii) remove any copyright, trademark, or other proprietary rights notices contained in or displayed on any portion of the website; (iii) “frame” or “mirror” any portion of the website, or link to any Material other than via the homepage of the URL located at https://www.ZUBSOLV.com or the URLs provided by us to you for such purposes, without our prior written authorization; (iv) use any robot, spider, site search/retrieval application, or other manual or automatic device or process to retrieve, index, data mine, or in any way reproduce or circumvent the navigational structure or presentation of the website; or (v) harvest or collect information about or from users of the website without their express consent and, if such consent is provided, only pursuant to applicable law. Orexo US, Inc. does not endorse any user submission or any opinion, recommendation, or advice expressed therein, and Orexo US, Inc. expressly disclaims any and all liability in connection with user Content. Orexo US, Inc. does not permit copyright infringing activities and infringement of intellectual property rights on the website, and Orexo US, Inc. reserves the right to remove Content without prior notice and/or to terminate a user’s access to the website, if the user has been notified of infringing activity and has had Content removed from the website more than twice. Orexo US, Inc. also reserves the right to decide whether Content is appropriate and complies with these Acceptable Use Restrictions at any time, without prior notice and at its sole discretion.
The website may contain links allowing you to leave the website for other sites that are not under our control (“Linked Sites”). Orexo US, Inc. provides the Linked Sites to you only as a convenience and does not endorse any Linked Sites. Orexo US, Inc. is not responsible for the contents or transmission of any Linked Site or any link contained in a Linked Site or for ensuring that the Linked Sites contain no errors or viruses. Orexo US, Inc. is not responsible for these Terms or privacy practices of the Linked Sites or any link contained in the Linked Sites. Your linking to any Linked Site or any other off-site page or other site is entirely at your own risk. Orexo US, Inc. encourages you to carefully read the policies of each site you visit.
United States Only
By using the website, you agree and acknowledge that the website is hosted in the United States. If you are attempting to access the website from a physical location within the European Union, Asia, or any other region with laws or regulations governing personal data collection, use, and disclosure that differ from United States laws, please be advised that through your continued use of this website, you are transferring your personal information to the United States. Any legal action brought under or in connection with your use of the Websites shall be brought only in the United States District Court for the Southern District of New York or, if such court would not have jurisdiction over the matter, then only in a New York State court sitting in the Borough of Manhattan, City of New York. Each party hereby completely and irrevocably submits to the exclusive jurisdiction of these courts and agrees not to commence any legal action under or in connection with the subject matter of this Agreement in any other court or forum. Each party waives any objection to the laying of the venue of any legal action brought under or in connection with the subject matter of this Agreement in the federal or state courts sitting in the Borough of Manhattan, City of New York, and agrees not to plead or claim in such courts that any such action has been brought in an inconvenient forum.
WITHOUT LIMITING THE FOREGOING, THE MATERIALS AND ALL OTHER FEATURES ON THE WEBSITE ARE PROVIDED TO YOU “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTY OF ANY KIND WITH RESPECT TO THE WEBSITE AND/OR MATERIALS, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NONINFRINGEMENT. SHOULD APPLICABLE LAW NOT PERMIT THE FOREGOING EXCLUSION OF EXPRESS OR IMPLIED WARRANTIES, THEN OREXO US, INC. HEREBY GRANTS THE MINIMUM EXPRESS OR IMPLIED WARRANTY REQUIRED BY SUCH APPLICABLE LAW. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM OREXO US, INC., ITS EMPLOYEES, AGENTS, SUPPLIERS OR ANY OTHER PERSONS SHALL CREATE ANY WARRANTY, REPRESENTATION, OR GUARANTEE NOT EXPRESSLY STATED IN THIS SECTION. ADDITIONALLY, OREXO US, INC. DOES NOT MAKE ANY WARRANTIES THAT THE WEBSITE WILL BE UNINTERRUPTED, SECURE OR ERROR FREE OR THAT YOUR USE OF THE WEBSITE WILL MEET YOUR EXPECTATIONS, OR THAT THE WEBSITE, MATERIALS, OR ANY PORTION THEREOF, IS CORRECT, ACCURATE, OR RELIABLE. OREXO US, INC. RESERVES THE RIGHT TO CHANGE ANY PART OF THE WEBSITE AT ANY TIME WITHOUT NOTICE.
Limitation of Liability
No Framing; Links; Third-Party Websites
Framing, in-line linking, or other methods of association with the website are expressly prohibited without prior written approval from Orexo US, Inc.
You affirm that you are more than 18 years of age, or an emancipated minor, or possess legal parental or guardian consent, and are fully able and competent to enter into the terms, conditions, obligations, affirmations, representations, and warranties set forth in these Terms, and to abide by and comply with these Terms.
Notwithstanding anything contained herein, the functionality provided to you by the website and the Orexo US, Inc.’s systems, networks, and servers are not an archive and Orexo US, Inc. shall have no liability to you or any other person for loss, damage, or destruction to your Content or any other information submitted to or via the website. You shall be solely responsible for (i) uploading your Content, (ii) preventing any loss or damage to your Content, and (iii) maintaining independent archival and backup copies of any Content.
These Terms, and any rights and licenses granted hereunder, may not be transferred or assigned by you, but may be assigned by Orexo US, Inc. without restriction.
Any limitations on liability that favor Orexo US, Inc. will survive the expiration or termination of these Terms for any reason.
Orexo US, Inc.’s failure to enforce any provision of these Terms shall not be deemed a waiver of such provision nor of the right to enforce such provision. If any part of these Terms is determined to be invalid or unenforceable pursuant to applicable law, including, but not limited to, the warranty disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of these Terms shall continue in effect. A printed version of these Terms and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to these Terms to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
Last updated: [February 28, 2015]
© 2014 Orexo US, Inc.
What is ZUBSOLV®?
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
IMPORTANT SAFETY INFORMATION
Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone as serious negative side effects, including anaphylactic shock, have been reported.
ZUBSOLV can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV.
ZUBSOLV contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your doctor can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
Your doctor may monitor liver function before and during treatment with ZUBSOLV.
ZUBSOLV is not recommended for initiation of treatment in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. However, ZUBSOLV may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.
Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away.
The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your doctor about any side effect that bothers you or that does not go away.
Opioid use may cause adrenal insufficiency, a potentially life-threatening condition. Seek immediate medical attention if you experience nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure as these are signs and symptoms that may be associated with adrenal insufficiency.
Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of ZUBSOLV is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking.
ZUBSOLV is not for occasional or ”as needed” use. An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death.
Do not inject (“shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking ZUBSOLV, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Cases of serotonin syndrome, a rare but potentially life-threatening condition, have been reported when opioids are used along with serotonergic drugs (such as medications used to treat depression and migraines). Be sure to inform your doctor if you are taking or plan to take any serotonergic medications while taking ZUBSOLV.
Before taking ZUBSOLV, tell your doctor if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have signs of withdrawal at birth and that withdrawal is treatable. Talk to your doctor if you are pregnant or plan to become pregnant.
Before taking ZUBSOLV, tell your doctor if you are breastfeeding or plan to breastfeed. Nursing mothers: Caution should be exercised when buprenorphine-containing products are administered to a nursing woman. Talk to your doctor about the best way to feed your baby. If you take ZUBSOLV, monitor your baby for drowsiness and difficulty breathing.
Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
This is not a complete list of negative side effects associated with ZUBSOLV. For a complete list please see full Prescribing Information.
To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.