This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US health care professionals only.

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Privacy Policy

This site is owned by Shire US Inc. This Online Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site or that we acquire from your use of the site. Please be sure to read this entire Online Privacy Policy before using, or submitting information to, this site.

Your Consent

By using this Shire site, you signify your consent to the collection, use and disclosure of the information that you provide to the site or that we secure from your use of the site. If you do not agree to this policy, please do not use this site. We reserve the right, at our discretion and where permitted by law, to change, modify, add, or remove portions of this policy at any time with or without notice. Please check this page periodically for changes. Your continued use of our sites following the posting of changes to these terms will mean you accept those changes.

About Children

Generally, we do not knowingly collect information from children on this site. We encourage parents to talk to their children and supervise their use of the Internet and the information they disclose to Web sites.

In some cases, there are treatments that pertain to children, and while this site is not intended for use by minors, you may have the opportunity to provide personal information about a child. Such information will only be used to provide the requested services, and for no other purposes.

About This Site

In our effort to bring you up-to-date and accurate product and resource information, we use various expert sources and studies to develop site content. As a result, you may find slight differences in statistics and/or percentages across various articles—because different sources can view data differently.

Information We Collect and How We Collect It

You can visit our site and view most of the content anonymously; however, we may collect information from you.

The information we gather on our site falls into three categories: (1) personally identifiable information you supply, (2) aggregate information collected as you navigate through our site, and (3) publicly or commercially available information.

Personally Identifiable Information Collection

Like many Web sites, this site actively collects information from its visitors both by asking you specific questions (for example, such as a registration) and by permitting you to communicate directly with us via e-mail, feedback forms, and/or chat rooms. Some of the information that you submit may be personally identifiable information (that is, information that can be uniquely identified with you, such as your full name, address, e-mail address, phone number, and so on).

Some areas of this site may require you to submit treatment and/or demographic information in order for you to benefit from the specialized features (such as newsletter subscriptions, tips/pointers, etc.) or to participate in a particular activity (such as promotions). You will be informed at each information collection point what information is required and what information is optional.

Social Media: Generally, online social media resources are interactive tools that enable you to collaborate and share information with others. Social media resources include but are not limited to social networks, discussion boards, bulletin boards, blogs, wikis, and referral functions to share Web site content and tools with a friend or colleague. Shire may collect personal information from you to enable you to use online social media resources we may occasionally offer to you. Shire may also enable you to use these social media resources to post or share personal information with others. When using social media resources, you should take into careful consideration what information about yourself you choose to share with others. Shire provides additional notice and choices about how personal information is collected, used and disclosed on our Web sites and other online resources that offer social media.

Mobile Computing: In addition to the uses described above for the Shire Web sites, some Shire Web sites and online resources are specifically designed to be compatible and used on mobile computing devices. Mobile versions of Shire Web sites may require that you log in with a user account for that Web site. Information about your use of the mobile version of the Web site will be associated with your user account. Further, some of our Web sites and online resources may enable you to download an application, widget or other tool that you can use on your mobile or other computing device. Some of these tools may store information on your mobile or other device. These tools may transmit personal information to Shire to enable you to access your user account and to enable Shire to track use of these tools. Some of these tools may enable you to e-mail reports and other information from the tool. Shire may use personal or non-identifiable information transmitted to Shire to enhance these tools, to develop new tools, for quality improvement and as otherwise described in this Policy or in other notices Shire provides.

Other Information Collection

As you navigate through a Web site, certain information can be passively collected (that is, gathered without your actively providing the information) using various technologies and means, such as navigational data collection. This site may use Internet Protocol (IP) addresses. An IP address is a number assigned to your computer by your Internet service provider so you can access the Internet. We use your IP address to diagnose problems with our server, report aggregate non-personally identifiable information, determine the fastest route to your computer in connecting to our site, and administer and improve the site.

We also collect information about your use of our site through cookies and similar technology. A "cookie" is a bit of information that a Web site sends to your computer that helps the site remember information about you and your preferences and recognize you as a return visitor to the site. Cookies, by themselves, do not tell us your e-mail address or other personally identifiable information. However, we may combine this information with other information collected from or about you in order to help customize content.

"Web beacons" (also known as Internet tags, single-pixel GIFs/PNGs, clear GIFs/PNGs, invisible GIFs/PNGs, and 1-by-1 GIFs/PNGs) are smaller than cookies and tell the Web site server information such as the IP address and browser type related to the visitor's computer. This site may at times use Web Beacons.

"Navigational data" ("log files," "server logs," and "clickstream" data) are used for system management, to improve the content of the site, for market research purposes, and to communicate information to visitors. This site may at times use navigational data.

Publicly/Commercially Available Information Collection

Publicly or commercially available information is defined as information that an individual makes or permits to be made available to the public, or is legally available through an independent list broker or other third party, and/or is legally obtained and accessed from, amongst other sources: government records that are available to the public, journalistic reports, or information that is required by law to be available. We may collect publicly available information or purchase commercially available information about you from third parties.

Use and Disclosure of Information

Except as otherwise stated, we may use your information to improve the content of our site, to customize the site to your preferences, to communicate information to you (if you have requested it), for our marketing and research purposes, to respond to access requests or to otherwise protect Shire's legal and business interests and rights, and for the other purposes specified in this Online Privacy Policy. If you provide personally identifiable information to this site, we may combine such information with other actively and passively collected information.

We may disclose your personally identifiable information to our affiliates worldwide that agree to treat it in accordance with this Online Privacy Policy. In addition, we may disclose your personally identifiable information to third parties located in countries outside of the one in which you reside that may have laws and regulations different than your own, but only (i) to contractors we use to support our business (e.g., fulfillment services, technical support, delivery services, market research providers, and financial institutions), in which case we will require such third parties to agree to treat it in accordance with this Online Privacy Policy; or (ii) where required by applicable laws, court orders, or government regulations; or (iii) to otherwise protect Shire's legal and business interests.

Length of Personal Information Retention

Personal information will be stored as long as the information is required to fulfill Shire's legitimate business needs or the purposes for which the information was collected, or until an individual whose data is involved requests that we delete that information (unless its retention is required by law).

Access and Correction

To keep your personally identifiable information accurate, current and complete, please contact us as specified below. We will take reasonable steps to update or correct or to remove personally identifiable information in our possession that you have previously submitted via this site or that we have acquired from other sources.

Security

We take commercially reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our site and to protect such information from loss, misuse, unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. Moreover, where you use passwords, ID numbers, or other special access features on this site, it is your responsibility to safeguard them.

Notification Procedures

In the event of an incident or security breach resulting in your personally identifiable information being accessed, lost, or stolen by an unauthorized third party, Shire will exercise commercially reasonable efforts to (i) notify you to the extent required by law; and (ii) identify the personally identifiable information that was accessed/disclosed using the contact information you have provided to us or by any other reasonable means.

Links to Other Web Sites

This site may contain links or references to other Web sites. Please be aware that Shire does not control other Web sites and that this Online Privacy Policy does not apply to those Web sites. We encourage you to read the privacy policy of every Web site you visit. We are not responsible for, nor do we endorse, the contents of these other Web sites. If you in any way rely on information obtained from any such Web sites, you do so at your own risk.

How to Contact Us / Accountability

If you have any questions, comments or concerns about this Online Privacy Policy or about the information practices of this site, or would like to have your information removed from our files, please contact us as follows:

Shire US Inc.
Attn: Online Privacy Policy
300 Shire Way
Lexington, MA 02421
USA
PrivacyConnect@shire.com

This policy was last revised August 20, 2015

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
  • Warnings and Precautions
    • Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with Vyvanse for ADHD. Treatment may need to be interrupted in children not growing as expected.
    • CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
    • Increased risk of serotonin syndrome when co-administered with serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately and initiate supportive treatment.
  • Adverse Reactions
    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in ADHD clinical trials were:
    • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
    • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
    • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
    The most common adverse reactions (≥ 5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.
  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
  • Other Considerations
    • Safety and effectiveness in patients <18 years with B.E.D. have not been established.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

Shire

All content of this Web site including text, images, graphics, sound files, and their arrangements, belongs to Shire and is protected by international copyrights laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or distribution nor may these objects be downloaded, modified, or posted to other sites.

This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our online privacy policy for more information. While Shire US Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site.

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