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This Website is exclusively owned and controlled by ADMA Biologics, Inc. (“ADMA”).

ADMA Biologics 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. Please do not use our Website if you do not agree to all Website Terms and Conditions. By using this Website, you represent that you are at least 18 years old.

Updates to Terms of Use

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.

Third Party Links

ADMA Biologics 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. 

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ADMA Biologics marks are trademarks and/or registered trademarks of ADMA Biologics, and are used with the explicit permission of ADMA Biologics.

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 ADMA Biologics to enforce its intellectual property rights to the fullest extent permitted under law. ADMA Biologics 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 ADMA Biologics prior written permission, except to identify ADMA Biologics’ products as such, is prohibited.

Nothing contained in this Website shall be construed as conferring any right or license to any party under any ADMA Biologics copyright, trademark, patent or any other intellectual property. 

Disclaimer

While ADMA Biologics 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. ADMA Biologics makes no representation that the information contained on the Website will be timely or error-free.

In no event will ADMA Biologics 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 ADMA Biologics is expressly advised of the possibility of such damages. 

If a user of the ADMA Biologics Website is dissatisfied with any portion of the website, or with any of these terms of use, the sole and exclusive remedy is to discontinue using the website. 

Medical Advice or Professional Services Not Provided

ADMA Biologics 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.

Applicable Law

The information contained in this Website 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 ADMA Biologics affiliates’ Websites may contain product information that may not be available or approved for sale in the U.S.

Important Safety Information for BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid]

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, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

  • 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 and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

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.

Thrombosis may occur following treatment with IGIV products, including BIVIGAM. Thrombosis may occur in the absence of known risk factors.

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/ markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable.

In patients at risk of developing acute renal failure, renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output need to be monitored.

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.

Passive transfer of antibodies with IGIV treatment may yield positive serological testing results, with the potential for misleading interpretation.

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 subjects) 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.