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.
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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.
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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.
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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.
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All Rights Reserved
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Boulevard, NW
Boca Raton, FL 33487
For Reimbursement Queries, please contact:
Phone: 1-855-248-4426 (BIVIGAM)
For Medical Information, please contact:
Toll free: 1-800-458-4244
For Adverse Events Reporting, please contact:
Toll Free: 1-800-458-4244
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.