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Legal Statement

MGI PHARMA, INC. ("MGI PHARMA") is providing the services of this website to you subject to the following conditions. If you visit Gliadel.com, you accept these conditions. Please read them carefully.

Copyright

All content included on this site, including, but not limited to text, graphics, logos, button icons, images, audio clips, digital downloads, data compilations, and software, is the property of MGI PHARMA or its content suppliers and is protected by US and international copyright laws. The collection, compilation, assembly, and arrangement of all content on this site is the exclusive property of MGI PHARMA and is protected by US and international copyright laws.

Trademarks

GLIADEL® Wafer, CaRe[SM], PAL[SM], and other marks indicated on our site from time to time are trademarks of MGI PHARMA, its subsidiaries or affiliates. This list is not exhaustive, and the absence of a mark from this list should not be viewed as a waiver by MGI PHARMA of any of its rights concerning that mark. Other MGI PHARMA product or service names, logos, graphics, page headers, button icons, and scripts are trademarks or trade dress of MGI PHARMA and may not be used, in any manner, in connection with any product or service that does not belong to MGI PHARMA and especially that which is likely to cause confusion in the marketplace or in any manner that disparages or discredits MGI PHARMA. All other trademarks not owned by MGI PHARMA that appear on this site are the property of their respective owners, who may or may not be affiliated with or connected to MGI PHARMA.

License and Site Access

MGI PHARMA grants you a limited license to access and make personal use of this site and not to download (other than page caching) or modify it, or any portion of it, except with the express written consent of MGI PHARMA. This license does not include any resale or commercial use of this site or its contents; any collection and use of any product listings or descriptions; any derivative use of this site or its contents; or any use of data mining, robots, or similar data-gathering and extraction tools. This site or any portion of this site may not be reproduced, duplicated, copied, sold, resold, visited, or otherwise exploited for any commercial purpose without the express written consent of MGI PHARMA. You may not frame or utilize framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, page layout, or form) of MGI PHARMA without the express written consent of MGI PHARMA. You may not use any meta tags or any other "hidden text" utilizing MGI PHARMA's name or trademarks without the express written consent of MGI PHARMA. Any unauthorized use terminates the permission or license granted by MGI PHARMA. You are granted a limited, revocable, and nonexclusive right to create a hyperlink to the home page of mgipharma.com so long as the link does not portray MGI PHARMA, its affiliates, or their products or services in a false, misleading, derogatory, or otherwise offensive manner. You may not use any MGI PHARMA logo or other proprietary graphic or trademark as part of the link without the express written consent of MGI PHARMA.

Feedback, Comments, Communications, and Other Content

Visitors may post comments and other content, send e-cards and other communications, and submit suggestions, ideas, comments, questions, or other information so long as the content is not illegal, obscene, threatening, defamatory, harassing, invasive of privacy, infringing of intellectual property rights, or otherwise injurious or objectionable to third parties, and does not consist of or contain software viruses or malicious code, political campaigning, commercial solicitation, chain letters, mass mailings, or any form of "spam". You may not use a false e-mail address, impersonate any person or entity, or otherwise mislead as to the origin of any content. MGI PHARMA reserves the right (but not the obligation) to remove or edit such content but does not regularly review posted content. If you post content or submit material, MGI PHARMA and its affiliates may use it royalty-free on an unrestricted basis, unless we indicate otherwise. In such event, you grant MGI PHARMA and its affiliates a nonexclusive, royalty-free, perpetual, irrevocable, and fully sublicensable right to use, reproduce, commercialize, modify, adapt, publish, translate, create derivative works from, distribute, and display such content throughout the world in any media. You grant MGI PHARMA and its affiliates and sublicensees the right to use any product idea and the name that you submit in connection with such content, if they so choose. You represent and warrant that you own or otherwise control all of the rights to the content that you submit, that the content is accurate, that use of the content you supply does not violate this policy and will not cause injury to any person or entity, and that you will indemnify MGI PHARMA or its affiliates for all claims resulting from your submissions. No material will be returned to you. MGI PHARMA has the right, but not the obligation, to monitor and edit or remove any submission. MGI PHARMA takes no responsibility and assumes no liability for any content posted by you or any third party.

Medical Information is Not Being Provided

MGI PHARMA is not engaged in rendering medical or similar professional services or advice through this site, and the information provided on this site is not intended to replace medical advice offered by a physician. You should not interpret our publication of the information on this site as an endorsement by MGI PHARMA of the views expressed on this site, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content.

Linking

Gliadel.com may contain links to sites operated by other parties. The linked sites are not under the control of MGI PHARMA and MGI PHARMA is not responsible for the content available on any other Internet sites linked to this site. Such links do not imply MGI PHARMA endorsement of material on any other site, and MGI PHARMA disclaims all liability with regard to your access to such linked sites. MGI PHARMA provides links to other sites as a convenience to users of this site, and access to any other site linked to this site is at your own risk.

Disclaimer of Warranties and Limitation of Liability

THIS SITE IS PROVIDED BY MGI PHARMA ON AN "AS IS" AND "AS AVAILABLE" BASIS. MGI PHARMA MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, AS TO THE OPERATION OF THIS SITE OR THE INFORMATION, CONTENT, MATERIALS, OR PRODUCTS INCLUDED ON THIS SITE. YOU EXPRESSLY AGREE THAT YOUR USE OF THIS SITE IS AT YOUR SOLE RISK. TO THE FULL EXTENT PERMISSIBLE BY APPLICABLE LAW, MGI PHARMA DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT. MGI PHARMA DOES NOT WARRANT THAT THIS SITE, ITS SERVERS, OR E-MAIL SENT FROM MGI PHARMA ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. MGI PHARMA WILL NOT BE LIABLE FOR ANY DAMAGES OF ANY KIND ARISING FROM THE USE OF THIS SITE, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY, AND CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF MGI PHARMA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES). CERTAIN STATE LAWS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR THE EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IF THESE LAWS APPLY TO YOU, SOME OR ALL OF THE ABOVE DISCLAIMERS, EXCLUSIONS, OR LIMITATIONS MAY NOT APPLY TO YOU AND YOU MIGHT HAVE ADDITIONAL RIGHTS.

Applicable Law

By visiting Gliadel.com, you agree that the laws of the state of Maryland, without regard to principles of conflict of laws, will govern these Terms of Use and any dispute of any sort that might arise between you and MGI PHARMA or its affiliates.

Disputes

Any dispute relating in any way to your visit to Gliadel.com shall be submitted to confidential arbitration in Baltimore, Maryland, except that, to the extent you have in any manner violated or threatened to violate MGI PHARMA intellectual property rights, MGI PHARMA may seek injunctive or other appropriate relief in any state or federal court in the state of Maryland, and you consent to exclusive jurisdiction and venue in such courts. Arbitration under this Agreement shall be conducted under the rules then prevailing of the American Arbitration Association. The arbitrator's award shall be binding and may be entered as a judgment in any court of competent jurisdiction. To the fullest extent permitted by applicable law, no arbitration under this Agreement shall be joined to an arbitration involving any other party subject to this Agreement, whether through class arbitration proceedings or otherwise.

Site Policies, Modification, and Severability

We reserve the right to make changes to our site, policies, and these Terms of Use at any time. If any of these conditions shall be deemed invalid, void, or for any reason unenforceable, that condition shall be deemed severable and shall not affect the validity and enforceability of any remaining condition. These Terms of Use govern your use of this site. The failure of MGI PHARMA to exercise or enforce any right or provision shall not constitute a waiver of such right or provision. You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to use of the site must be filed within six (6) months after such claim arose or be forever barred.

Prescribing Information

Important Safety Information

Indications:
GLIADEL® Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Contraindication:
GLIADEL® Wafer should not be given to patients who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL.

Warnings:
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema.

Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL, including one case leading to brain herniation.

Precautions:
Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus. If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation.

Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of GLIADEL. This enhancement may represent edema and inflammation caused by GLIADEL or tumor progression.

The short-term and long-term toxicity profiles of GLIADEL when given in conjunction with chemotherapy have not been fully explored.

Pregnancy and Nursing:
There are no studies assessing the reproductive toxicity of GLIADEL. Carmustine, the active component of GLIADEL, can cause fetal harm when administered to a pregnant woman.

It is recommended that patients receiving GLIADEL discontinue nursing.

Adverse Events:

Seizures:
In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving GLIADEL and 37.5% in patients receiving placebo. Grand mal seizures occurred in 5% of GLIADEL-treated patients and 4.2% of placebo-treated patients. The incidence of seizures within the first 5 days after wafer implantation was 2.5% in the GLIADEL group and 4.2% in the placebo group.

In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in both patients receiving GLIADEL and placebo. In this study, 12/22 (54%) of patients treated with GLIADEL and 2/22 (9%) of placebo patients experienced the first new or worsened seizure within the first five post-operative days. The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with GLIADEL and 61 days in placebo patients.

Brain Edema:
In the initial surgery trial, brain edema was noted in 22.5% of patients treated with GLIADEL and in 19.2% of patients treated with placebo. Development of brain edema with mass effect (due to tumor recurrences, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL or its remnants.

Healing Abnormalities:
The following healing abnormalities have been reported in clinical trials of GLIADEL: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak. In the initial surgery trial, healing abnormalities occurred in 15.8% of GLIADEL-treated patients and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of GLIADEL recipients and 0.8% of those given placebo. During surgery, a water-tight dural closure should be obtained to minimize the risk of cerebrospinal fluid leak.

In the surgery for recurrent disease trial, the incidence of healing abnormalities was the 14% of GLIADEL treated patients and 5% in patients receiving placebo wafers.

Intracranial Infection:
In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with GLIADEL and 6% in patients receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with GLIADEL and 1% in patients receiving placebo.

Please see the Prescribing Information for more information.

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GLIADEL® Wafer is a registered trademark of MGI PHARMA, INC.
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