Biotest Pharmaceuticals Corporation has been issued a J-Code from CMS for BIVIGAM®[Immune Globulin Intravenous (Human), 10% Liquid].
The BIVIGAM issued J-Code is J1556 and is effective as of January 1, 2014.
|J1556||Injection, immune globulin (BIVIGAM), intravenous, non-lyophilized (e.g., liquid),||500 mg||1/1/2014|
If you have any questions or require additional information about BIVIGAM, please contact the BIVIGAM CareLine at 1-855-BIVIGAM (855-248-4426).
As a provider of therapies for chronic disorder, Biotest Pharmaceuticals Corporation is sensitive to your privacy. The BIVIGAM Cares® Program is being administered by a third party, independent provider that specializes in support and advocacy programs for families taking care of family members with chronic illnesses. The third-party Program Administrator manages the Program website. As soon as you push the I AGREE button, you will leave BIVIGAM.com and you will be redirected to www.BIVIGAMCares.com, which is completely independent from BIVIGAM.COM. As soon as you have finished the enrollment process for the BIVIGAM Cares® Program and/or have read the program information, you will not be automatically returned to the BIVIGAM.com website. If you want to return to the BIVIGAM.COM website, you would have to actively decide to come back to this site.
Biotest Pharmaceuticals Corporation will not have access to any of the confidential information associated with your participation in the BIVIGAM Cares® Program without your consent. The Program Administrator will use your confidential information only with your consent and in accordance with the terms of the Program, the Program website and applicable law.
The user agrees to the following Terms and Conditions for this Website:
This Website is exclusively owned and controlled by Biotest Pharmaceuticals Corporation (“Biotest Pharmaceuticals”).
Biotest Pharmaceuticals is pleased to provide you with the materials on our Website for informational purposes only. Please carefully read these Terms and Conditions relating to your use of our Website. By using our Website, you agree to these terms and conditions. If you do not agree to these Terms and Conditions, please do not use our Website. We reserve the right to revise these Terms and Conditions or any portion of them at any time without notice by updating this posting. You are bound by any revisions and should periodically visit this page to review the current Terms and Conditions that apply to your use of our Website.
By using this Website, you represent that you are at least 18 years old.
Third Party Links
Biotest Pharmaceuticals has provided links to certain third party Websites as a courtesy, but we have not reviewed or controlled the content of all of these sites. By providing these certain links, we are not endorsing, adopting, or agreeing with any of the content of all linked sites. The content of all linked sites is not part of our Website. We expressly disclaim any responsibility for the content of all third party sites linked to our Website. We urge you to use discretion when you access any third party site linked to our Website and, such access to certain websites is at the user's own risk.
The content of this Website including, but not limited to, text, graphics, designs and layouts, is the copyrighted property of Biotest Pharmaceuticals. Website pages may be downloaded solely for personal, non-commercial use, but there may be no alteration or further reproduction of any site content in any way. Unauthorized use is strictly prohibited.
It is the policy of Biotest Pharmaceuticals to enforce its intellectual property rights to the fullest extent permitted under law. All product names are trademarks of Biotest Pharmaceuticals, its affiliates, licensors or collaborators, unless otherwise noted. The entire content of the Biotest Pharmaceuticals Website, including any images or text, is copyrighted and may not be distributed, downloaded, modified, reused, reposted or otherwise used except as provided herein without the express written permission of Biotest Pharmaceuticals. Biotest Pharmaceuticals trademarks, service marks, trade names, trade dress, domain names and products displayed on this Website are protected both in the United States and internationally. Use of any of the foregoing without Biotest Pharmaceuticals prior written permission, except to identify Biotest Pharmaceuticals' products as such, is prohibited.
Nothing contained in this Website shall be construed as conferring any right or license to any party under any Biotest Pharmaceuticals copyright, trademark, patent or any other intellectual property.
While Biotest Pharmaceuticals makes every reasonable effort to keep its Website up-to-date and accurate; information on this Website may contain technical inaccuracies or typographical errors. In addition, where this site provides links or references to other Websites, it does so purely as a convenience to users of this site. We do not warrant that the functions or informational materials contained in or accessed through our Website are free of computer viruses or other harmful components.
The information provided on this Website is provided on an "as-is" basis for informational purposes only. Such information is provided without any warranties (express or implied), including but not limited to non-infringement, fitness for a particular purpose, and the implied warranty of merchantability. Biotest Pharmaceuticals makes no representation that the information contained on the Website will be timely or error-free.
In no event will Biotest Pharmaceuticals be liable to any party for any damages (direct, indirect, special, or consequential) whatsoever whether based in tort, negligence, contract, strict liability, or otherwise from any use of this website for any, including without limitation, lost profits, business interruption, loss of programs, or other data on the user's information handling system, or otherwise, even if Biotest Pharmaceuticals is expressly advised of the possibility of such damages.
Medical Advice or Professional Services Not Provided
Biotest Pharmaceuticals is not engaged in rendering medical or similar professional services. Any information provided is not intended to be a substitute for medical advice offered by a physician. Patients and other individuals in need of medical care are urged to contact their physicians or other healthcare providers
If any provision of these Terms and Conditions is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of these Terms and Conditions shall remain in full force and effect. Any provision of the Terms and Conditions held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable. The parties further agree to replace such invalid or unenforceable provision of these Terms and Conditions with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other purposes of such invalid or unenforceable provision.
Biotest Pharmaceuticals’ Website is administered from our offices in the state of Florida, U.S.A. The terms and conditions will be governed by and construed in accordance with the laws of Florida without regard to any conflict of law provisions thereof.
This Website is based in the U.S. and does not adhere to the regulations of any country or jurisdiction other than the U.S. It is intended for U.S. residents ONLY and as such, product names, descriptions and labeling are of U.S. origin. Products may not be available in all countries. The therapeutic products listed are available only by prescription through a healthcare professional. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any product that is not authorized by applicable laws and regulations.
The links to Biotest Pharmaceuticals affiliates’ Websites may contain product information that may not be available or approved for sale in the U.S.
These Terms and Conditions represent the entire agreement between you and Biotest Pharmaceuticals relating to the subject matter herein and shall not be modified except by Biotest Pharmaceuticals as provided herein or through a written document signed by both parties.
All rights not expressly granted herein are reserved to Biotest Pharmaceuticals.
© Copyright 2012 Biotest Pharmaceuticals
All Rights Reserved
BIVIGAM is manufactured by Biotest Pharmaceuticals Corporation (“Biotest Pharmaceuticals”), a US subsidiary of Biotest AG.
Biotest AG (“Biotest”) is a German-based global provider of plasma protein therapies, with a specialization in clinical immunology, hematology, and intensive care medicine. Biotest markets products in approximately 90 countries worldwide. These products meet or exceed standards for safety and efficacy in all countries where they are sold.
Biotest was founded in 1946 and focused on research in blood typing serology. Biotest’s first commercial product, introduced in 1948, was the test serum anti-D, one of the first of its kind, which was used for the determination of the Rhesus factor. Since then, Biotest has been producing plasma proteins for over 60 years, and is one of the world’s leading suppliers of plasma-derived therapeutics.
Biotest formed Biotest Pharmaceuticals, as a US subsidiary in 2007, with the purchase of Nabi Biopharmaceuticals’ biologics strategic business unit, consisting of Nabi-HB® [Hepatitis B Immune Globulin (Human)] and other plasma business assets, including a plasma protein production plant and plasma collection centers across the United States.
Biotest Pharmaceuticals is headquartered in Boca Raton, Florida. During the past 4 years, Biotest has invested over 50 million dollars to expand and modernize the US manufacturing facility.
The Boca Raton manufacturing facility has been licensed by the Food and Drug Administration since October 2001 to produce commercial immune globulin products, such as Nabi-HB® [Hepatitis B Immune Globulin (Human)]. Additionally, the facility has been certified by the PPTA Quality Standards of Excellence, Assurance and Leadership (QSEAL) program since 2008. The QSEAL standards surpass those of the regulatory agencies that define the minimum acceptability of plasma for use in the manufacturing of plasma protein products.
Manufacturing is conducted in our state-of-the-art, recently modernized, and expanded manufacturing plant in Boca Raton, Florida. This major modernization began in 2008 and was completed in July 2011. The facility changes were designed to expand the manufacturing capacity and improve the compliance of the facility with cGMPs. For plasma protein therapy products, the essential objective of cGMP compliance is to minimize risk, while maintaining adequate production to meet the therapeutic needs of patients. Through the use of scientifically sound design, our plant achieves a high level of quality. Biotest is committed to high-quality processes and continuous improvement.
Our manufacturing process employs a multistep viral removal/inactivation system, which further increases the safety of all our plasma protein based products. The following Biotest Pharmaceuticals’ manufacturing processes have been validated for their capability to eliminate or inactivate viruses: precipitation during cold ethanol fractionation, solvent/detergent treatment, and nanofiltration. Incorporation of these processes in the manufacturing process ensures that our products fully comply with the requirements of the FDA and are safe and efficacious.
BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Warning: Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose recommended and infusion rate practicable. Ensure adequate hydration in patients before administrations. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for viscosity. See full Prescribing Information for complete boxed warning.
BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.
Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥ 5% of clinical study subject) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, diarrhea, dizziness, and lethargy.
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.
For more information about BIVIGAM® please see full Prescribing Information.