Terms of Use

Kedrion Biopharma Inc. ("Kedrion Biopharma") operates certain websites (“Website”) for personal information and education purposes.  By visiting our Website, or by registering as a user of the on-line services that we provide, you agree to these Terms of Use and to our Privacy Policy as they may be amended from time to time.  If you do not agree to the Terms of Use, do not enter the Website.  Kedrion Biopharma (“we”, “us”, “our”) means our entire company, including our United States affiliates, subsidiaries and related companies.  

Use of Website and Intellectual Property

All documents, text, graphics, photos, interactive features, presentations, materials, or such other informational materials in all forms on this Website (“Website Information”) are the property of Kedrion Biopharma unless otherwise indicated.  You may view, print or download one copy of Website Information (except for third party materials identified as such) solely for your personal, informational, non-commercial use, provided you keep all copyright and other proprietary notices intact.  You may not otherwise, in whole or in part, copy, reproduce, modify, republish, upload, post, transmit or distribute in any form, or create any derivative work based on such Website Information, without Kedrion Biopharma’s prior written permission.  No links to our Website may be included in a third party website without our prior written permission.  

All product names, whether or not appearing with the trademark symbol, are trademarks of Kedrion Biopharma unless otherwise indicated.  Except as expressly permitted herein, the use of these trademarks or any Website Materials is expressly prohibited and may be in violation of copyright, trademark and other similar laws.  The entire contents of this Website are subject to copyright protection.  No license or other right under any patent or trademark of Kedrion Biopharma or any third party or to Website Information is granted to you.

Subject to our Privacy Policy, you agree that any material or information you submit through or to the Website will not be deemed confidential or proprietary and permit us to use, disclose, copy, modify, adapt or otherwise publicly display all or any of such material for any purpose whatsoever without restriction.  You represent and warrant that you will not submit any material to the Website unless you have the unrestricted right to submit or authorize Kedrion Biopharma to use such material, and shall indemnify Kedrion Biopharma and hold it harmless against any claim of infringement arising out of such material.  We reserve the right, in our discretion, to remove or delete any material you submit through or to the Website without notice to you. 

Third Party Websites

Our Website may contain links to third party websites that are not owned, affiliated or operated by Kedrion Biopharma.  These links are provided for your information only.  We have no control over any third party website and do not endorse, sponsor or recommend your use of such website.  We are not responsible for the content of third party websites and shall not be liable for any damages or injury arising from your use of such websites.  Accordingly, we recommend that you read the applicable third party terms and privacy policies for more information.

Disclaimer and Limitations of Liability

THE WEBSITE INFORMATION IS PROVIDED “AS-IS” AND WITHOUT ANY WARRANTY WHATSOEVER, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.  KEDRION BIOPHARMA MAKES NO REPRESENTATIONS AS TO THE AVAILABILITY, ACCURACY OR COMPLETENESS OF THIS WEBSITE OR THAT THIS WEBSITE OR SERVER IS FREE OF VIRUSES OR MALICIOUS CODE.  IN NO EVENT WILL KEDRION BIOPHARMA AND ITS OFFICERS, DIRECTORS, EMPLOYEES AND AGENTS BE LIABLE TO YOU FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THIS WEBSITE INCLUDING, WITHOUT LIMITATION, LOSS OF REVENUES OR PROFITS (WHETHER IN CONTRACT OR TORT), EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Indemnity

You agree to defend, indemnify and hold harmless Kedrion Biopharma and its officers, directors, employees, and agents, from any and all liability and claims for damages and costs or injury (including attorney’s and expert’s fees) caused by, or resulting from, your use of and access to the Website, violation of these Terms of Use, any third party’s intellectual property rights and/or your negligent acts, willful misconduct or omissions.

Medical Information

This Website may contain medical information. Such information is provided for informational purposes only and is not intended to be a substitute for informed medical advice provided by a doctor or other qualified healthcare professional. You should consult with a qualified doctor or other healthcare professional for medical advice or information related to any information on this Website before taking any action.

Privacy

We take the protection of personal information that you provide on our Websites and through other means very seriously.  Please refer to Kedrion Biopharma’s Privacy Policy.

General

This Website and its contents are intended to comply with the laws and regulations in the United States and intended for use only by United States residents.  These Terms of Use shall be governed by, construed and enforced in accordance with the laws of the State of New York, without respect to its conflict of laws principles.  Exclusive venue for any disputes arising under these Terms of Use shall be in New York City, New York.  Kedrion Biopharma reserves the right to modify or delete any part of the Website at any time and without notice to you.  Kedrion Biopharma reserves the right to terminate your access to the Website, in its sole discretion, for any violation of the Terms of Use and to remove or take down any content posted on the Website in violation, or suspected to be in violation, of the Terms of Use.  

Updates to Terms of Use

We reserve the right to modify our Terms of Use at any time so please review the Terms of Use each time you access the Website.  Material changes will be indicated on the revised Terms of Use.  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 Terms of Use at uslegal@kedrion.com or Kedrion Biopharma Inc., 400 Kelby Street, Fort Lee, NJ 07024, Attn: Legal Department.

Last updated: May 2017

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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) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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) may occur 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:
                    - Increased cough, stuffy nose, sore throat, headache, asthma, nausea, fever, diarrhea, and sinus
                    infection, when administered intravenously to patients with PI. 

                    - Swelling and itching at the injection site, fatigue, headache, upper respiratory infection, joint pain,
                    diarrhea, nausea, sinus infection, bronchitis, depression, allergic skin reactions, migraine, muscle
                    pain, viral infection, and fever, when administered subcutaneously to patients with PI.

                  - Headache, bruising, vomiting, fever, nausea, rash, abdominal pain, back pain, and indigestion
                    in patients with ITP.

                  - Headache, fever, increased blood pressure, chills, rash, nausea, joint pain, 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 effect.
  • 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.

©2018 Kedrion Biopharma Inc. All Rights Reserved. June 2018 GM-0110-03-2018