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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Acquired immune deficiency: immune deficiency disorder acquired during one’s lifetime; may be due to infection, drugs, radiation, etc.
Agammaglobulinemia: absence of immunoglobulins in the blood
Acquired immune deficiency syndrome (AIDS): a disease caused by HIV virus infection
Anemia: an abnormal condition when the hemoglobin or red blood cells are below normal
Antibody: a protein in the blood that is produced by certain white blood cells; develops primarily in response to foreign antigens; important for immunity against certain germs
Antigen: a substance recognized as foreign by the body; stimulates antibody production and a T cell response
Autoimmune: describes a condition characterized by a specific immune response against the body’s own tissues
Autoantibody: an antibody that reacts against the body’s own tissue
B lymphocyte (B cell): a small white blood cell from bone marrow responsible for producing antibody and serving as a precursor for plasma cells
Combined immunodeficiency: a condition when both T cells and B cells are inadequate or lacking
Complement: one of at least 20 serum proteins important in immunity and inflammation
Cytokine: small proteins produced by cells that affect the physiology and function of other cells
Deoxyribonucleic acid (DNA): constitutes the genetic material in the chromosomes
Enzyme: protein that helps chemical reactions
Gammaglobulin: immune globulins, predominantly IgG, used primarily for treating hypogammaglobinemia
Gamma interferon: a cytokine primarily produced by T cells; important in immunoregulation and protection from viral infection; improves bacterial killing by phagocytes; treatment for CGD
Gene: a biological unit of heredity composed of DNA that has a specific function
Gene therapy: a new treatment for replacing defective or missing genes to restore normal function
Graft-versus-host-disease (GVHD): a condition after transplantation when the donor’s tissue reacts against the recipient’s tissue
Granulocyte colony-stimulating factor (G-CSF): a cytokine that stimulates proliferation, development, and function of white blood cells called granulocytes
Granulocyte-macrophage colony-stimulating factor (GM-CSF): a cytokine that stimulates proliferation, development, and function of red and white blood cells, including granulocytes and macrophages
Human immunodeficiency virus (HIV): infects and destroys immune cells and causes AIDS
Hypogammaglobulinemia: a condition where all classes of immunoglobulins in the blood are abnormally low
Immunodeficiency: a condition where the immune response is deficient or subnormal
Immunoglobulin (Ig): any of 5 classes (IgM, IgG, IgA, IgE, IgD) of antibody
Intravenous immune globulin (IVIG): a treatment to deliver immune globulins directly into the blood of the patient
Lymphocyte: a small, mononuclear, nonphagocytic white blood cell found in the blood, lymph, or lymphoid tissue; major cell of the immune system that is essential for immunity
Neutrophil: a polymorphonuclear phagocytic white blood cell containing characteristic granules
Opportunistic infection: an infection by germs that do not usually cause disease, but occurs only under certain conditions, such as in immune deficient or immunosuppressed patients
Phagocyte: a cell (eg, neutrophil, monocyte, or macrophage) capable of engulfing material or other cells and digesting them
Plasma cell: a cell that produces antibody and is descended from B cells
Platelet: a structure in blood that functions in blood coagulation
Primary immunodeficiency (PI): immune deficiency due primarily to inheritance of altered or mutated genes that can be passed from parent to child or can arise as genes are copied
Protein: a substance composed of amino acids found in living matter and essential for growth, repair, and structure; also function in chemical reactions (enzymes)
Secondary immune deficiency: immune deficiency that is acquired and not inherited
Sepsis: germs or their toxins in the blood or tissues
Stem cell: a progenitor cell that can develop into different blood cell types
T lymphocyte (T cell): thymus-dependent lymphocyte that matures in the thymus; important in cell-mediated immunity and helping B cells
Thrush: a fungal disease characterized by white plaques on mucous membranes; caused by Candida albicans infection
Thymus: a lymphoid organ in front of the heart that is important for immunity and development of T cells
Reference: 1. National Institute of Child Health and Human Development, National Institutes of Health. Primary immunodeficiency: when the body’s defenses are missing. http://www.nichd.nih.gov/publications/pubs/primary_immuno.cfm. Updated April 7, 2008. Accessed January 3, 2012.
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.