The websites may also include Web pages of Orexo AB, which are designated as “Global,” and Web pages of Orexo US, Inc. US parent company, which are designated as “International Pages.” The International Pages are provided by their designated entities and not by Orexo US, Inc. Entities. The International Pages, as well as other websites, applications, or services that do not display or link to this Policy, or that display or link to different privacy statements, are not governed by this privacy statement.
We encourage visitors to review the applicable privacy statements before disclosing any personal information.
This privacy statement may be supplemented or amended from time to time by privacy statements that are specific to certain areas of the Orexo US, Inc. websites.
If you have any questions or concerns regarding this privacy statement, please contact us using the Contact Us link.
We may collect information about you in various ways when you use our websites. As a visitor, you do not have to submit any personal information in order to use the websites. The websites collect personal information only if it is voluntarily provided by visitors.
We do not solicit, request, or require users to submit, nor do we want users to submit any “sensitive information,” such as data relating to race or ethnic origin, religious beliefs, criminal record, physical or mental health, or sexual orientation.
HOW THE INFORMATION IS USED
We use personal information collected through our websites for purposes described in this Policy or disclosed to you on our websites or in connection with our services. For example, we may use your information to:
- Operate and improve our websites, products, and services;
- Understand you and your preferences to enhance your experience and enjoyment using our websites, products, and services;
- Process and deliver contest entries and rewards;
- Respond to your comments and questions and provide customer service;
- Provide and deliver the products and services you request;
- Send you related information, including confirmations, invoices, technical notices, updates, security alerts, and support and administrative messages;
- Communicate with you about new contests, promotions, rewards, upcoming events, and other news about products and services offered by Orexo US, Inc. and our selected partners; and
- Link or combine your information with other personal information we get from third parties, to help understand your needs and provide you with better service.
You may at any time request that we discontinue sending you e-mails or other communications generated in response to your registration on the Orexo US, Inc. websites.
SHARING OF PERSONAL INFORMATION
Information You Share
Our websites allow you to connect and share certain content publicly. Should you choose to share content through the websites, you do so at your own risk. Please be mindful of your own privacy needs as you choose what to share and make public, as Orexo US, Inc. has no control over information you choose to share with others.
In addition, areas of the websites have features that will allow you to track your own personal information and make entries into our websites such as journal entries, system reminders, and communications. To protect your own privacy, we request that all users of our websites refrain from posting or sharing information regarding their patient support on other forms of media other than those provided by the websites.
Information We Share
We do not share your personal information with third parties other than as follows:
- To (i) comply with laws or to respond to lawful requests and legal process, (ii) to protect the rights and property of Orexo US, Inc. Entities, or (iii) in an emergency to protect the personal safety of Orexo US, Inc. Entities, its customers, or any person;
- With your consent;
- With third-party vendors, consultants, and other service providers who work for us and need access to your information to do that work;
- With third-party vendors under confidentiality obligations to conduct market research or provide you with information that may be of interest to you;
- In connection with or during negotiation of any merger, financing, acquisition, or dissolution, transaction, or proceeding involving sale, transfer, divestiture, or disclosure of all or a portion of our business or assets to another company.
All of these disclosures may involve the transfer of personal information to municipalities, counties, or states without data protection rules similar to those in effect in your area of residence. We may also share aggregated or information not personally identifiable to you.
SECURITY OF YOUR PERSONAL INFORMATION
We take commercially reasonable steps to help protect your personal information against loss, misuse, and unauthorized access, disclosure, alteration, and destruction.
Our websites are not designed for, or intentionally targeted at, children 13 years of age or younger.
Orexo US, Inc. and its suppliers, agents, and assigns may retain records associated with the websites for a period of one (1) year from the last validated prescription entered by a participant.
Information at the point of retention expiration will be deleted from the websites and be unable to be retrieved by Orexo US, Inc., our customer service team, or technical support. These websites are not and shall not function as an archive. We shall have no liability to you or any other person for loss, damage, or destruction to your information, including any content submitted by you to our websites. You shall be solely responsible for maintaining independent archival and backup copies of your information.
CHANGES TO THIS POLICY
We may modify or amend our privacy or acceptable use policies from time to time at our discretion. When we make changes to our policies, we will amend the revision date at the top of this page.
YOUR INFORMATION CHOICES
You may opt out of receiving promotional e-mails from us by following the instructions in those e-mails. If you opt out, we may still send you non-promotional e-mails, such as e-mails about your accounts or our ongoing business relations. You have a right to know about the personal information that Orexo US, Inc. holds about you. You also have a right to correct, amend or delete the information that Orexo US, Inc. holds about you if it is incorrect. You may exercise these rights and/or send requests about your contact preferences and changes to your information, including requests to opt out of sharing your personal information with third parties by contacting us by clicking here.
This website is intended for use only by U.S. residents and you have indicated that you are a U.S. resident by entering this website.
Orexo US, Inc.
150 Headquarters Plaza, East Tower
Morristown, NJ 07960
Last updated: [February 6, 2015]
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.