Terms & Conditions

Terms & Conditions

By using this website, you agree to be bound the terms and conditions set out below which are subject to change without notice to you:

  1. Limited License and Use
    Aptevo Therapeutics Inc. ("Aptevo Therapeutics") grants you a limited license to display the contents of this website on your computer and print, download and use the materials on this website solely for non-commercial, personal or educational purposes, provided that the contents of the website are not modified in any way and that all copyright, trademark and other notices are maintained. You agree not to, or allow others to, directly or indirectly, attempt or actually disrupt, impair or interfere with, alter or modify this website or any of its content. Except as expressly provided herein, Aptevo Therapeutics does not grant any express or implied right to you under any of its patents, trademarks, copyrights or trade secret information. This website is for general information purposes only and is not intended to provide you with any personalized drug, health, medical or other professional advice. Any medical information provided should not be considered as a substitute for the advice of a physician, nor should it be used to diagnose a health problem or disease. Nothing on this website constitutes an offer to buy or sell products or services of Aptevo Therapeutics or any of its affiliated companies. All such products and services are subject to the terms and conditions of any applicable contracts and are available only in jurisdictions where they may be lawfully offered for sale.

  2. Links
    This website contains links to other websites which websites are not maintained or controlled by Aptevo Therapeutics nor has Aptevo Therapeutics reviewed all of the websites that may link to this website. Aptevo Therapeutics does not warrant the accuracy, completeness, timeliness, non-infringement or fitness for a particular purpose of such websites or any information available through these links and disclaims any opinions expressed on such websites. Links on this website are provided for convenience only and are not to be construed as an endorsement by Aptevo Therapeutics of the products, services, advice or opinions or any other content of such websites.

  3. Product and Scientific Information
    This website contains information about Aptevo Therapeutics' products which may not be available in a particular country, and if available, may have received approval or market clearance by applicable regulatory authorities for different indications or restrictions. Nothing on this website shall be construed as a solicitation or promotion for any product or for any indication for a product which is not authorized by the applicable laws of the country where the user resides. Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information presented on this website. Prescribing information and product names may differ in various countries.

  4. Trademarks
    Aptevo Therapeutics owns or has obtained the right to use by license or otherwise the trademarks used on or in connection with the product that it provides. "Winrho®SDF" is a trademark owned by Aptevo Therapeutics. Trademarks are protected by U.S., Canadian, and foreign trademark laws. All rights reserved. The display of trademarks on this website shall not in any way be construed as an implied license to use such trademarks.

  5. Copyright
    This website has been developed by and is the property of Aptevo Therapeutics. All information and materials contained on this website are protected by copyright, trademark and other intellectual property laws of the United States and other countries. Subject to the limited license to use this website as described herein, no person may copy, redistribute, reproduce or republish in any form, or link to this website or its contents in any manner whatsoever, including by way of hyperlinks or framing, unless that person has obtained the prior written consent of Aptevo Therapeutics. Any infringement of the rights of Aptevo Therapeutics may result in appropriate legal action.

  6. E-mail Security
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  7. Privacy
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  8. Changes
    The content on this Website may be updated from time to time, but its content is not necessarily complete or up-to-date. Any of the material on the Website may be out of date at any given time, and we are under no obligation to update such material.

  9. Disclaimer
    The content of this website is provided for informational and educational purposes only and is subject to modification without notice to you. While information posted on this website is believed to be reliable and accurate at the time of posting, Aptevo Therapeutics does not guarantee, represent or warrant that the information contained on this website is accurate, complete, reliable, verified or error-free. Aptevo Therapeutics makes no express or implied representations or warranties regarding the usability or condition of this website, that this website will operate uninterrupted or error-free, or that this website will operate in combination with any services or software used in connection therewith or that it shall be viewed consistently with all browser software or that any communication transmitted to or from this website is private, confidential or secure. APTEVO THERAPEUTICS EXPRESSLY DISCLAIMS ALL REPRESENTATIONS, WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES AND CONDITIONS OF MERCHANTABLE QUALITY AND FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, COMPATIBILITY, TIMELINESS, SECURITY OR ACCURACY, AND ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS THAT MAY ARISE FROM A COURSE OF DEALING OR USAGE OF TRADE. WE WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY A DISTRIBUTED DENIAL-OF-SERVICE ATTACK, VIRUSES OR OTHER TECHNOLOGICALLY HARMFUL MATERIAL THAT MAY INFECT YOUR COMPUTER EQUIPMENT, COMPUTER PROGRAMS, DATA OR OTHER PROPRIETARY MATERIAL DUE TO YOUR USE OF THE WEBSITE OR ANY SERVICES OR ITEMS OBTAINED THROUGH THE WEBSITE OR TO YOUR DOWNLOADING OF ANY MATERIAL POSTED ON IT, OR ON ANY WEBSITE LINKED TO IT.

  10. Limitation of Liability
    YOU ASSUME FULL RESPONSIBILITY FOR RISK OF LOSS OF ANY NATURE WHATSOEVER RESULTING FROM YOUR USE OF THIS WEBSITE. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, YOU ACKNOWLEDGE AND AGREE THAT NONE OF APTEVO THERAPEUTICS OR ANY OF ITS AFFILIATES, OR ANY OF THEIR DIRECTORS, OFFICERS, EMPLOYEES OR AGENTS SHALL BE LIABLE TO YOU FOR LOSS OF DATA, COMPUTER TIME OR ANY LOSS OR DAMAGE OF ANY NATURE WHATSOEVER ARISING OUT OF OR ATTRIBUTABLE IN ANY MANNER WHATSOEVER TO YOUR USE OR INABILITY TO USE THIS WEBSITE FOR ANY REASON WHATSOEVER OR TO ANY ACTION OR INACTION ON THE PART OF APTEVO THERAPEUTICS OR FOR ANY DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, EVEN IF APTEVO THERAPEUTICS HAS BEEN ADVISED OF THE POSSIBILITY THEREOF, INCLUDING BUT NOT LIMITED TO LOST PROFITS, LOST OPPORTUNITIES OR BUSINESS REVENUES, LOSS OF GOODWILL, OR FAILURE TO REALIZE EXPECTED SAVINGS.

  11. General Provisions
    These terms and conditions shall be governed by the laws of the State of Washington and the Federal laws of the United States applicable therein. You agree that any legal actions arising from this website and these terms and conditions must be commenced in the courts of the State of Washington. These terms and conditions are binding on you, your heirs, executors, administrators, legal representatives, successors and assigns. No waiver of by the Company of any term or condition set forth in these Terms of Use shall be deemed a further or continuing waiver of such term or condition or a waiver of any other term or condition, and any failure of the Company to assert a right or provision under these Terms of Use shall not constitute a waiver of such right or provision. If any provisions of these terms and conditions are determined to be invalid or unenforceable, everything else herein shall continue in full force and effect. Unless specified otherwise, dollar amounts are in U.S. dollars. You requested that these terms and conditions and any related documents be in English.

Important Safety Information

WARNING: INTRAVASCULAR HEMOLYSIS (IVH)

Intravascular hemolysis leading to death has been reported in patients treated for ITP with WinRho® SDF.

IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).

Serious complications including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have also been reported.

Closely monitor patients treated with WinRho® SDF for ITP in a healthcare setting for at least eight hours after administration. Perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and 2 hours, 4 hours, and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours does not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho® SDF administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

INDICATION

WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rho(D)-positive:

  • Children with chronic or acute immune thrombocytopenia (ITP)
  • Adults with chronic ITP
  • Children and adults with ITP secondary to HIV infection

The safety and efficacy of WinRho® SDF have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rho(D)-negative.

Important Safety Information

For use in the treatment of ITP, do not use WinRho SDF in:

  • Patients who have had known anaphylactic or severe systemic reaction to the administration of human immune globulin products
  • IgA deficient patients with antibodies to IgA and a history of hypersensitivity
  • Patients with autoimmune hemolytic anemia, with pre-existing hemolysis or at high risk for hemolysis

The liquid formulation of WinRho® SDF contains maltose. Maltose in IGIV products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving WinRho® SDF Liquid.

WinRho® SDF is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The safety and efficacy of WinRho® SDF have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rho(D)-negative.

Acute renal dysfunction/failure, osmotic nephropathy, and death may occur upon use of Immune Globulin Intravenous (IGIV) products, including WinRho® SDF. Ensure that patients are not volume depleted before administering WinRho® SDF. For patients at risk of renal dysfunction or failure, including those with any degree of pre‑existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs, administer WinRho® SDF at the minimum infusion rate practicable.

In Rho(D)-positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably decreased hemoglobin, can be expected. In most cases, the red blood cell destruction is believed to occur in the spleen.

Thrombotic events may occur following treatment with WinRho® SDF and other IGIV products.

Noncardiogenic pulmonary edema [Transfusion-related Acute Lung Injury (TRALI)] may occur in patients following IGIV treatment.

General adverse reactions associated with the use of WinRho® SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events (≤2% of infusions) were headache, chills, and fever.

Please see full Prescribing Information for complete prescribing details.