This site is intended for U.S. health care professionals only.

Privacy Policy

The Medicines Company respects your privacy and recognizes the need for appropriate protection and management of any personally identifiable information you may share with us (the phrase “personally identifiable information” or “personal information” means any information by which you can be identified, such as your name, address, telephone number, etc.). The purpose of this Privacy Policy is to inform you how we may use personally identifiable information or personal information collected from you when you visit our Web site or enroll in a clinical trial in the European Economic Area or Switzerland and the choices you have regarding our use of, and your ability to review and correct, the information collected.

Collection of Data from Website Visits

There may be times when we ask you to provide certain personal information about yourself, such as your name, address, telephone number, E-mail address, etc. Whether or not to provide such information is completely your own choice; we collect only the personal information that you provide to us. If you choose not to provide the information we request, you may be unable to access certain services, offers, and content on our Web site.

To enable us to provide customized and personalized services, we may use a passive tracking mechanism referred to as “cookies.” A cookie is a small amount of data that is sent to your browser from a Web server and stored on your computer. Cookies, by themselves, do not tell us any personally identifiable information about you. However, if you choose to furnish this Web site with personally identifiable information (such as your E-mail address), that information could be linked to the data stored in the cookie. We reserve the right to change our use of cookies and our practices regarding linkage to personally identifiable information without prior notification.

Use of Data from Website Visits

We use the information we automatically receive from your Web browser to see which pages you visit within our Web site. We can then develop statistics that are helpful to understanding how our Web site is used by our visitors. This statistical data is interpreted by us in our continuing effort to present Web site content that visitors are seeking in the format they find most helpful.

When we receive personally identifiable information, we may use it for reasonable business purposes, such as contacting you, via e-mail or regular mail, to provide you with information we believe may be of interest.

We will not sell, share, or otherwise distribute your personally identifiable information to third parties except as provided herein. Specifically, personally identifiable information may occasionally be transferred to third parties who act on our behalf, or in connection with our business, for further processing in accordance with the purposes for which the data was originally collected. Where disclosure of personally identifiable information to a third party is likely or necessary, further explanation may be provided, where appropriate, at such collection points as to the intended use of the data. We will require that such third parties protect the information and, where appropriate, we will contractually require them to process data transferred only for the purposes expressly authorized by us.

Because of the nature of the Internet, we may transmit the information to another country, while still maintaining the information in our system, for purposes other than direct marketing, such as for storage, or because of where our servers are located. We may also use the information to investigate security breaches or cooperate with authorities pursuant to a legal matter. We may remove the personally identifiable information and use the other information for historical, statistical, or scientific purposes. Our Web site contains links to other Web sites. Be aware that we are not responsible for the privacy practices of other Web sites.

European Data Subjects

With respect to clinical trial participants and customers in the European Economic Area and Switzerland, The Medicines Company complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Economic Area countries and Switzerland. The Medicines Company has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view our certification, please visit http://www.export.gov/safeharbor/.

In compliance with the US-EU and US-Swiss Safe Harbor Principles, The Medicines Company commits to resolve complaints about your privacy and our collection or use of your personal information. European Union or Swiss citizens with inquiries or complaints regarding this privacy policy should first contact The Medicines Company by email at: dataprivacy@themedco.com or by mail at: The Medicines Company, 8 Sylvan Way, Parsippany, New Jersey 07054, Attn: Head of Global Contracting and Business Ethics. The Medicines Company has further committed to refer unresolved privacy complaints under the US-EU and US-Swiss Safe Harbor Principles to an independent dispute resolution mechanism, the BBB EU SAFE HARBOR, operated by the Council of Better Business Bureaus. If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed by The Medicines Company, please visit the BBB EU SAFE HARBOR web site at www.bbb.org/us/safe-harbor-complaints for more information and to file a complaint.

Consent

Use of this Web site constitutes consent from this web site to data collection and use as described in this Policy.

User Responsibilities

It is important for all users to take precautionary steps to protect their personal and health-related information. Users should monitor and control access to their computer.

Children

This Web site is not intended or designed to attract children under the age of 13. We do not collect personally identifiable data from any person we know to be under the age of 13.

Updates

The Medicines Company reserves the right to change, modify, add or remove sections of this Policy, in part or in whole. Any changes to this Policy will be updated on this page. This Policy was last updated on September 27, 2011.

Contact Information

If you have any questions or concerns, please do not hesitate to contact The Medicines Company at 800-377-5768 or investor.relations@themedco.com. For European clinical trial data questions or concerns contact dataprivacy@themedco.com.

Important Safety Information

WARNING: HOSPITAL USE ONLY; LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS REMS; ADDICTION, ABUSE, AND MISUSE; and CYTOCHROME P450 3A4 INTERACTION

Life Threatening Respiratory Depression

  • Use of IONSYS may result in potentially life-threatening respiratory depression and death as a result of the active drug, fentanyl. Only the patient should activate IONSYS dosing.
  • Accidental exposure to an intact IONSYS or to the hydrogel component, especially by children, through contact with skin or contact with mucous membranes, can result in a fatal overdose of fentanyl.
  • IONSYS is for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital.

IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program

  • Because of the potentially life-threatening respiratory depression resulting from accidental exposure, IONSYS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the IONSYS REMS Program.

Addiction, Abuse, and Misuse

  • IONSYS exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing and monitor regularly for development of these behaviors or conditions.

Cytochrome P450 3A4 Interaction

  • The concomitant use of IONSYS with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving IONSYS and any CYP3A4 inhibitor or inducer.

Contraindications

Warnings and Precautions

Adverse Reactions

Most common (frequency ≥2%) adverse reactions are headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention.

www.ionsys.com

This site is intended for U.S. Healthcare Professionals. If you are a U.S. Healthcare Professional, click OK to continue.

Ok
Cancel