Privacy Policy

Kedrion Biopharma Inc. ("Kedrion Biopharma") understands that the security of your private information is important and we take the protection of personal data that you provide on our websites (“Website”) and through other means very seriously. This privacy policy (“Privacy Policy”) describes how we collect, manage, use, protect and disclose the information that you may provide via our Website. By visiting our Website, or by registering as a user of the on-line services that we provide, you agree to the terms of this Privacy Policy and to our Terms of Use as they may be amended from time to time.  Kedrion Biopharma (“we”, “us”, “our”) means our entire company, including our United States affiliates, subsidiaries and related companies. 

 Our site may contain links to third party websites that are not owned or controlled by Kedrion Biopharma.  This Privacy Policy only applies to information collected by Kedrion Biopharma, and does not apply to any information collected by any third party.  Accordingly, we recommend that you read the applicable third party privacy policies and terms for more information.

Collection and Use of Personal Information

You can use our Website without disclosing your personal data. You are not required to provide personal information as a condition of using our Website, except as may be necessary to provide you with information, products or services at your request.  If you request information, products, or services from our Website, or ask us to resolve complaints or concerns, we may require certain information necessary to fulfill your request (e.g., your name, contact information, and other identifying information).  Personal information that you provide may be used by Kedrion Biopharma to provide you with information, such as educational and marketing information about our products. We may use your information for market research and other marketing purposes, and for the purposes specified in this Privacy Policy.  Please do not submit any personal information if you do not want it to be collected. 

 We collect personal information only when you provide it to us, through registration, completion of forms or e-mails, as part of an order for products or services, inquiries or requests about materials being ordered and similar situations in which you have chosen to provide the information to us.  If you choose not to provide any requested personal information, you may be unable to access certain areas of the Website, such as password protected areas.  We will retain control of and responsibility for the use of any personal information you disclose to us.  

Disclosure of Personal Information

Kedrion Biopharma does not sell or rent your personal information to unauthorized third parties. We may retain third party vendors to assist us to perform services on your behalf.  Such third party vendors may be provided with access to your personal information to perform their obligations but for no other purpose.  We may share your personal information with a company in connection with the sale or transfer of one of our product lines, business units or affiliates to that company.  Such company will be required to use and protect your personal information consistent with this Privacy Policy.  Kedrion Biopharma reserves the right to disclose your personal information to respond to duly authorized information requests from governmental authorities or when otherwise required by law.

Right of Access, Correction and Cancellation/Opt-Out

You have the right to review, correct, amend, change and delete your preferences, your personal information stored in our system, or withdraw your consent to the use of your personal data in the future.  You also have the right to opt-out of our communications and discontinue receiving educational and/or promotional information at any time.  Please contact our Legal Department at the address below.  

Use of Cookies

Cookies are used in order for us to improve the efficiency of your individual use of the Website.  Cookies are small text file identifiers that are sent to your web browser and stored on your computer’s hard drive.  Cookies allow the Website to remember your computer on return visits.  This is particularly important for websites that require you to sign in as it speeds up your access. We may use both session cookies that are deleted when you close your web browser and persistent cookies that may be used by the Website on subsequent visits.  When you use our Website, we automatically receive the name of you internet service provider, the website that you used prior to our Website, the websites that you visit from our Website and your Internet protocol address.  This information is not linked to personally identifiable information. 

Most web browsers are set up to accept cookies automatically but you can change the web browser’s settings to refuse new cookies, disable existing ones or let you know before new cookies are stored on your computer.  However, if you refuse or disable cookies, some of the Website’s functionality may be lost.  We may also include web beacons (also known as web bug, pixel tag or clear GIFs) on our Website or e-mails.  Web beacons help us monitor the effectiveness of the Website by measuring the activity of the Website or how many users clicked on any elements of the Website.  Web beacons do not automatically obtain personal information from you but can tell us when you have opened your email or visited the Website.  If you want to delete any cookies or web beacons that are already on your computer or stop cookies or web beacons being stored on your computer in the future, see the “Help” section of your web browser.  For additional information about deleting or controlling cookies or web beacons, see www.aboutcookies.org.

Security

Kedrion Biopharma uses reasonable technical and organizational security precautions to protect your personal information from manipulation, loss, destruction or access by unauthorized persons.  Any personal data that is provided to Kedrion Biopharma by you will be encrypted in transit to prevent its possible misuse by third parties. Our security procedures are continuously revised based on new technological developments.  Due to the nature of Internet communications, we cannot guarantee that such communications are 100% secure or error-free and disclaim that the information you provide us will remain free from theft, loss, or unauthorized access or use by third parties, despite our best efforts.  You are responsible for maintaining the privacy of your own passwords and other special access numbers you might use to access the Website.

Children

Children under the age of 13 are not the intended audience for the Website.  In light of the importance of protecting children’s privacy, we do not knowingly collect personal information from this age group without prior parental or legal guardian consent.

Updates to Privacy Policy

We reserve the right to modify our Privacy Policy at any time so please review the Privacy Policy each time you access the Website.  Material changes will be indicated on the revised Privacy Policy.  Any changes will be effective immediately as of the updated revision date indicated below.

Contact Us

Please contact us with any problems, questions or suggestions regarding our Privacy Policy at USLegal@Kedrion.com or Kedrion Biopharma Inc., 400 Kelby Street, Fort Lee, NJ 07024, Attn: Legal Department.

Last updated: November 22, 2016

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Important Safety Information

APPROVED USES
GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is approved to treat Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic Purpura (ITP), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

GAMMAKED may cause: 

1. Blood Clots (Thrombosis). Blood clots may occur in patients taking immune globulin intravenous (IGIV) products, including GAMMAKED. You may be at greater risk for blood clots if you are of advanced age, sit or lie for long periods, have a clotting condition or a history of blood clots, take estrogen hormones, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these known risk factors. 
2. Impaired kidney function or kidney failure. IGIV products, particularly those that contain sugar (sucrose), have been reported to be associated with kidney dysfunction and damage, kidney failure, and death. Kidney damage and kidney failure happen more often in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over age 65, are seriously dehydrated, have a blood infection (sepsis), have a blood condition called paraproteinemia, or take drugs that can damage your kidneys.

  • Do not use GAMMAKED if:
                    - You have a history of severe allergic reactions to human immune globulin. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human immune globulin. Ask if you are not sure.

                    - You have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and have a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.
  • Severe allergic reactions may occur with IGIV products, including GAMMAKED. IgA deficient patients who have antibodies against IgA are at greater risk of developing severe allergic reactions. Your healthcare provider should have medications, such as epinephrine, to immediately treat any sudden severe allergic reactions.
  • If you are receiving GAMMAKED, you could experience higher than normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.
  • Brain inflammation or brain swelling called Aseptic Meningitis Syndrome (AMS) has been reported infrequently with IGIV products, including GAMMAKED, especially if you receive a high dose or a rapid infusion.
  • Blood damage called hemolysis and hemolytic anemia can develop after treatment with GAMMAKED. Your healthcare provider will monitor you for signs and symptoms of hemolysis and hemolytic anemia.
  • Swelling of the lungs may occur in patients following IGIV treatment, including GAMMAKED. Your healthcare provider will monitor you for signs of lung damage (also known as transfusion-related acute lung injury [TRALI]).
  • GAMMAKED is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
  • Be sure to tell your healthcare provider about your recent history of vaccinations.  Live vaccines for disease like measles, mumps, rubella and varicella may not work as well for you while you are receiving GAMMAKED. Tell your healthcare provider that you are taking GAMMAKED before you receive any vaccination.
  • In clinical studies, the most common side effects of GAMMAKED were:
                    - Headache, cough, injection site reaction, nausea, sore throat, and rash, when administered intravenously to patients with PI.

                    - Redness, swelling and itching at the injection site, headache, influenza, fatigue, pain (including pain in the back, joints, arms, legs) and fever, when administered subcutaneously to patients with PI.
                  - Headache, vomiting, fever, nausea, back pain, and rash in patients with ITP.
                  - Headache, fever, chills, high blood pressure, rash, nausea, and weakness in patients with CIDP.
  • During treatment with GAMMAKED, be sure to tell your healthcare provider about any unusual symptoms you experience as they may indicate a possible side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088. 

Please click here for the GAMMAKED Full Prescribing Information.

©2017 Kedrion Biopharma Inc. All Rights Reserved. September 2017 GM-0110-02-2017