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Terms of Use

  1. Acceptance. Please read this Terms and Conditions of Use carefully before using this Web site. By using this Web site, you confirm your agreement with all the Terms and Conditions of Use and agree that you are responsible for compliance with any laws applicable to such use. Pinnacle Biologics, Inc. and its affiliates (collectively referred to herein as “the Company”) reserve the right to modify the Terms and Conditions of Use of this Web site at any time without notice and without updating the content of this Web site. By continuing to use this Web site after such updates are posted, you convey your acceptance of such changes.
  2. Web Site Users. THE ONLY PERSONS AUTHORIZED TO USE THIS WEB SITE ARE PERSONS WHO ARE RESIDENT IN THE UNITED STATES. You should not construe anything in this site as a promotion or solicitation for any product that is not authorized for sale in the United States.
  3. Content. (a) Although the Company strives to provide on this Web site the latest developments relating to Photofrin®, and other information about the Company, the Company does not warrant the accuracy, effectiveness and suitability of any information contained in this Web site.  Each person assumes full responsibility and all risks arising from use of this Internet site. The information is presented “AS IS” and may include technical inaccuracies or typographical errors. The Company reserves the right to make additions, deletions, or modifications to the information at any time without any prior notification.
    (b)  THE CONTENT OF THIS WEB SITE IS PROVIDED TO YOU ON AN “AS IS”/“AS AVAILABLE” BASIS WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE  OR NONINFRINGEMENT OF INTELLECTUAL PROPERTY OR OTHER VIOLATION OF RIGHTS. THE COMPANY MAKES NO WARRANTY AS TO THE COMPLETENESS, ACCURACY, TIMELINESS, LIKELY RESULTS OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEB SITE OR ANY SITES LINKED TO THIS WEB SITE. IT IS YOUR RESPONSIBILITY TO VERIFY ANY INFORMATION CONTAINED IN THIS WEB SITE BEFORE RELYING ON IT. SOME JURISDICTIONS DO NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSIONS MAY NOT APPLY TO YOU. The Company does not warrant that the functions contained in this Web site will be uninterrupted or error-free, that defects will be corrected, or that this Web site or the server that makes it available are free of computer viruses.
  4. Disclaimer of Liability. IN NO EVENT SHALL THE COMPANY BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT), CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THIS WEB SITE AND/OR THE INFORMATION CONTAINED IN THIS WEB SITE, REGARDLESS OF WHETHER THE COMPANY HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES. SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGE, SO THESE LIMITATIONS MAY NOT APPLY TO YOU.
  5. Copyright Notice. The content of this Web site is protected by applicable copyright, trademark and other intellectual property laws. All material published in this Web site (including but not limited to images, illustrations, information, documents and related graphics) is the sole property of the Company and may not be reproduced, modified, uploaded, downloaded, posted, transmitted, republished or distributed without the Company’s written permission. Modification of the content or use of the content for any other purpose is a violation of the copyrights and other proprietary rights of the Company.
  6. Trademarks. PHOTOFRIN® is the registered trademarkof the Company. No use of the trademark or of the service marks, trade names, trade dress or images of products in this Web site may be made without the prior written authorization of the Company, except to identify the product or services of the Company.
  7. Product/Medical Information. This Web site is not designed to provide a diagnosis or medical advice and should not be relied on or interpreted as doing so. Any information in this Web site relating to various health and medical conditions is provided for information purposes only. It is not meant to be a substitute for the advice provided by a physician or other healthcare professional. You should always consult a physician or healthcare provider for your personal medical needs.
  8. Use and Share of Information. This site may provide links to other Web sites maintained by third parties. The Company is not responsible for the content or accuracy of such other sites and shall not be responsible for any damages or injury arising from users’ access to such sites. Links to other sites are provided only as a convenience to users of this Web site. The inclusion of any link does not imply endorsement by the Company of such Web site.
  9. No Confidential Relationship Established. No confidential relationship shall be established in the event that any user of this Web site should make any oral, written or electronic response to the Company (such as feedback, questions, comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall be considered non-confidential, and the Company shall be free to reproduce, publish or otherwise use such information, without any obligation, in any media and for any purposes whatsoever on an unrestricted basis including, without limitation, the research, development, manufacture, use, sale or promotion of products incorporating such information. The sender of any information to the Company waives any moral rights that he/she may have therein in favor of the Company. The sender of any information to the Company is fully responsible for its content, including its truthfulness and accuracy and its non-infringement of any other person’s proprietary rights.
  10. General. Photofrin.com was created and is operated under the laws of the State of Illinois. The laws of the State of Illinois will control the terms and conditions provided in these Terms and Conditions of Use, without giving effect to any principles of conflict of laws. Any action you, any third party or the Company bring to enforce this agreement or, in connection with, any matters related to this Web site shall be brought only in the courts of the Northern District of Illinois, and you expressly consent to the jurisdiction of said courts. If a court of competent jurisdiction finds that any provision of these Terms and Conditions of Use is invalid or unenforceable, you agree that the other provisions of these Terms and Conditions of Use will remain in full force and effect. You agree that regardless of any applicable law to the contrary, you cannot file a claim or cause of action arising out of or related to Photofrin.com or these Terms and Conditions of Use more than one (1) year after such claim or cause of action arose. This is the entire agreement between you and the Company relating to the matters contained herein and shall not be modified except in writing, signed by the Company.
    ©2011 Pinnacle Biologics, Inc.

Important Safety Information

Contraindications

  • PHOTOFRIN® is contraindicated in patients with porphyria
  • Photodynamic therapy (PDT) is contraindicated in patients with an existing tracheoesophageal  or bronchoesophageal fistula
  • PDT is contraindicated in patients with tumors eroding into a major blood vessel
  • PDT is not suitable for emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection with PHOTOFRIN® and laser light treatment
  • PDT is not suitable for patients with esophagealor gastricvarices, or patients with esophagealulcers >1 cm in diameter

Warnings and Precautions

  • Do not initiate PHOTOFRIN® with PDT in patients with esophageal tumors eroding into the trachea or bronchial tree or  bronchial wall because of the high likelihood of tracheoesophageal or bronchoesophageal fistula
  • Gastrointestinal perforation can occur
  • High risk of bleeding in patients with esophageal varices
  • High risk for fatal massive hemoptysis with endobronchial tumors that are large, centrally located; cavitating; extensive,  extrinsic to the bronchus
  • All patients who receive PHOTOFRIN® will be photosensitive and must observe precautions to avoid exposure of skin and  eyes to direct sunlight or bright indoor light for at least 30 days. Ocular sensitivity is also possible; instruct patients when out   doors to edema, bronchostenosis wear dark sunglasses. See full Prescribing Information
  • Allow 2-4 weeks between PDT and subsequent radiotherapy• Substernalchestpainmayoccuraftertreatmentbecause of inflammatory responses within the area of treatment
  • Treatment-induced inflammation can cause airway obstruction. Administer with caution to patients  with tumors in locations where treatment-induced inflammation can obstruct the main airway
  • Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity• Thromboembolic events can occur following photodynamic therapy with PHOTOFRIN®

Adverse Reaction Profile

  • Most toxicities associated with PHOTOFRIN® therapy are local effects seen in the area of illumination and occasionally in  surrounding tissues and are characteristic of an inflammatory response
  • All patients who receive PHOTOFRIN® will be photosensitive and must observe precautions listed in the Prescribing  Information
  • Photosensitivity reactions occurred in approximately 20% of cancer patients treated with PHOTOFRIN® in clinical studies
  • Typically these reactions were mostly mild to moderate erythema but they also included swelling, pruritus, burning sensation,  feeling hot, or blisters. In a single study of 24 healthy subjects, some evidence of photosensitivity reactions occurred in all  subjects
  • Other less common skin manifestations were also reported in areas where photosensitivity reactions had occurred, such as  increased hair growth, skin discoloration, skin nodules, increased wrinkles and increased skin fragility. These manifestations  may be attributable to a pseudoporphyria state (temporary drug-induced cutaneous porphyria)
  • Conventional ultraviolet (UV) sunscreens will only protect against UV light-related photosensitivity and will be of no value in  protecting against induced photosensitivity reactions caused by visible light

Most Common Adverse Reactions

The following adverse reactions were reported in >10% of patients:

  • Esophageal Cancer: Anemia, pleuraleffusion, pyrexia, constipation, nausea, chestpain, pain, abdominal pain, dyspnoea,  photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis
  • Obstructing Endobronchial Cancer: Dyspnea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia
  • Superficial Endobronchial Tumors: Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis

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