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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BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin G (IgG) antibodies.
BIVIGAM is indicated for patients with primary humoral immunodeficiency(e.g., agammaglobulinemia, hypogammaglobulinaemia, CVID, SCID). The product contains a broad spectrum of neutralizing IgG subclasses similar to that of normal plasma; those antibodies are directed against bacterial and viral pathogens and their toxins in order to avoid recurrent serious opportunistic infections.
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.