The information in this section is intended for health care providers in the United States. I certify that I am a health care provider in the United States.
References
1. WinRho SDF Prescribing Information, Kamada Therapeutics, June 2018.
2. Papagianni A, Economou M, Tragiannidis A, et al. Standard-dose intravenous anti-D immunoglobulin in the treatment of newly diagnosed childhood primary immune thrombocytopenia. J Pediatr Hematol Oncol. 2011;33:265-269.
3. Gaines AR. Acute onset hemoglobinemia and/ or hemoglobinuria and sequelae following Rho(D) immune globulin intravenous administration in immune thrombocytopenic purpura patients. Blood. 2000;95:2523-2529.
4. Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood. 2005;106:1532-1537.
5. Data on file. Kamada Therapeutics.
6. Despotovic JM, Lambert MP, Herman JH, et al. RhIG for the treatment of immune thrombocytopenia: consensus and controversy. Transfusion. 2011;1537-2995.
Privacy Policy
Aptevo Therapeutics LLC ("Company" or "We") respect your privacy and are committed to protecting it through our compliance with this policy.
This policy describes the types of information we may collect from you or that you may provide when you visit the website Winrho.com (our "Website") and our practices for collecting, using, maintaining, protecting, and disclosing that information.
This policy applies to information we collect:
- On this Website.
- In email, text, and other electronic messages between you and this Website.
It does not apply to information collected by us offline or through any other means, including on any other website operated by any third party, including through any application or content (including advertising) that may link to or be accessible from or on the Website.
Please read this policy carefully to understand our policies and practices regarding your information and how we will treat it. If you do not agree with our policies and practices, your choice is not to use our Website. By accessing or using this Website, you agree to this privacy policy. This policy may change from time to time. Your continued use of this Website after we make changes is deemed to be acceptance of those changes, so please check the policy periodically for updates.
The information we collect automatically is statistical data and does not include personal information. It helps us to improve our Website and to deliver a better and more personalized service, including by enabling us to:
- Estimate our audience size and usage patterns.
- Store information about your preferences, allowing us to customize our Website according to your individual interests.
- Speed up your searches.
- Recognize you when you return to our Website.
The technologies we use for this automatic data collection may include:
- Cookies (or browser cookies). A cookie is a small file placed on the hard drive of your computer. You may refuse to accept browser cookies by activating the appropriate setting on your browser. However, if you select this setting you may be unable to access certain parts of our Website. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies when you direct your browser to our Website.
- Flash Cookies. Certain features of our Website may use local stored objects (or Flash cookies) to collect and store information about your preferences and navigation to, from, and on our Website. Flash cookies are not managed by the same browser settings as are used for browser cookies.
- Web Beacons. Pages of our Website and our e-mails may contain small electronic files known as web beacons (also referred to as clear gifs, pixel tags, and single-pixel gifs) that permit the Company, for example, to count users who have visited those pages or opened an email and for other related website statistics (for example, recording the popularity of certain website content and verifying system and server integrity).
Some content or applications on the Website may be provided by third-parties, including advertisers, ad networks and servers, content providers, and application providers. These third parties may use cookies alone or in conjunction with web beacons or other tracking technologies to collect information about you when you use our website. The information they collect may be associated with your personal information or they may collect information, including personal information, about your online activities over time and across different websites and other online services. They may use this information to provide you with interest-based (behavioral) advertising or other targeted content.
We do not control these third parties' tracking technologies or how they may be used. If you have any questions about an advertisement or other targeted content, you should contact the responsible provider directly.
Disclosure of Your InformationWe may disclose aggregated information about our users, and information that does not identify any individual, without restriction.
We may also disclose your personal information:
- To comply with any court order, law, or legal process, including to respond to any government or regulatory request.
- To enforce or apply our terms of use or terms of sale and other agreements, including for billing and collection purposes.
- If we believe disclosure is necessary or appropriate to protect the rights, property, or safety of Aptevo Therapeutics Inc., our customers, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction.
California Civil Code Section § 1798.83 permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please send an email or write us using the information provided below.
Data SecurityWe have implemented measures designed to secure your personal information from accidental loss and from unauthorized access, use, alteration, and disclosure. All information you provide to us is stored on our secure servers behind firewalls.
Unfortunately, the transmission of information via the internet is not completely secure. Although we do our best to protect your personal information, we cannot guarantee the security of your personal information transmitted to our Website. Any transmission of personal information is at your own risk. We are not responsible for circumvention of any privacy settings or security measures contained on the Website.
Changes to Our Privacy PolicyIt is our policy to post any changes we make to our privacy policy on this page. The date the privacy policy was last revised is identified at the top of the page. You are responsible for periodically visiting our Website and this privacy policy to check for any changes.
Contact InformationTo ask questions or comment about this privacy policy and our privacy practices, contact us at:
2401 4th Ave. Suite 1050
Seattle, WA 98121
USA
Attn: Shawnte Mitchell, Mitchells@apvo.com
Customer Service Phone: 1-888-616-0855
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.
WinRho® SDF [RHo(D) Immune Globulin (Human)] and all Kamada brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Kamada in the United States and/or other countries. Copyright 2018 Kamada Pharmaceuticals.All rights reserved.