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The Medicines Company (MDCO)

Please read the following paragraphs carefully before using this web site. By using this web site, you signify your assent to the conditions included in this notice and disclaimer.

The Medicines Company maintains this web site from its offices in Parsippany, New Jersey, United States of America. The Medicines Company makes no representation that materials in this web site are appropriate or available for use in other locations. Those who choose to access this web site from other locations do so on their own initiative and are responsible for compliance with local or national laws, if and to the extent local or national laws are applicable.

Statements contained on this website about our position and the success of our products in the marketplace, the development of our products and the acquisition of additional products and all other statements that are not purely historical, are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Some of the important factors that may cause or contribute to such differences include the commercial success of Angiomax®(bivalirudin), whether the Company’s products will advance in the clinical trials process, whether the Company’s products will receive approval from regulatory agencies, physician’s acceptance of clinical trial results, and the Company’s ability to identify, select and acquire additional product candidates, as well as the risk factors detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission. We specifically disclaim any obligation to update these forward-looking statements.

You may freely download material from this web site. Any and all downloaded materials may be used by you for personal, non-commercial use only. You may not, however, distribute, modify, transmit, reuse, repost or use any of such materials for public or commercial purposes, without The Medicines Company’s express written permission. All copyright and other proprietary notices contained in downloaded materials must be retained.

You should assume that all contents of this web site are copyrighted unless otherwise noted and may not be used except as provided herein and without The Medicines Company's express written permission.

The trademarks and logos displayed on this web site are registered and unregistered trademarks of The Medicines Company. Nothing contained in this web site should be construed as granting, by implication, estoppel or otherwise, any license or right in and to the trademarks or logos without The Medicines Company's express written permission. Your misuse of the trademarks or logos on this web site and in its contents is strictly prohibited.

Any communication or material that you transmit to, or post on, this web site by electronic mail or otherwise, including any data, questions, comments, suggestions or the like, is, and will be treated as, non-confidential and nonproprietary information. The Medicines Company and any of its affiliates, may use such communication or material for any purpose whatsoever, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and further posting. Further, The Medicines Company and its affiliates, are free to use any ideas, concepts, know-how or techniques contained in any communication or material you send to this web site for any purpose whatsoever.

The Medicines Company makes no representation or warranties as to the accuracy of any information contained herein and expressly disclaims any obligation to update said information. The Medicines Company further assumes no liability or responsibility for any errors or omissions in the content of this web site.

Your use of this web site is at your own risk. Neither The Medicines Company nor any other party involved in creating, producing or delivering this web site is liable for any direct, incidental, consequential, indirect or punitive damages arising out of your access to, or use of, this web site. This includes damages to, or for viruses that may infect, your computer equipment. Without limiting the foregoing, EVERYTHING ON THIS WEB SITE IS PROVIDED TO YOU "AS IS" WITHOUT WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you. Check your local laws for any restrictions or limitations regarding the exclusion of implied warranties.

This web site also contains links to other web sites. The Medicines Company is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by The Medicines Company of the third-party web site. The Medicines Company does not have any knowledge of the information contained in such other web sites, nor does The Medicines Company have any control over the content on such web site. The Medicines Company therefore does not take any responsibility whatsoever for information contained on other web sites. Your linking to any other off-web site pages or other web sites is at your own risk.

The Medicines Company may, at any time, revise this notice and disclaimer by updating this posting. You are bound by any such revisions and should, therefore, periodically visit this page to review the then-current conditions applicable to your use of this web site.

Important Safety Information


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.


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.

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