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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In a Phase III, open label, multicenter study of BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] in 63 patients with PI, 2 of the patients developed acute serious bacterial infections (aSBIs) over the period between the first infusion of BIVIGAM and the first follow-up visit (median treatment duration 317.3 days with a range of 66-386 days).1
During the study, 2 of the 58 ITT patients (3%) were hospitalized and 64% of the ITT patients experienced no absences from school/work due to an infection or other medical problem1; the patients in the clinical study missed 2.3 days off work or school/patient/year.
The Immune Deficiency Foundation (IDF) performed a "National Survey of Patients: 2008" with Primary Immune Deficiency patients. In this survey only 10% of the responding 1,030 patients never missed any day of work or school prior to diagnosis. In the same survey patients reported that they missed an average of 36.8 days of work or school prior to diagnosis.2
Graph: Percent of patients that never missed a day of work or school; 93% of study participants missed between 0 and 7 days in the 12 months study period.
2 of the 58 ITT patients required a hospitalization due to infection; more than 96% of the patients did not require any hospitalization during the study due to infection.1
As there were a low number of hospitalized patients in the ITT population, the study group experienced 0.21 hospitalization days/patient/year, giving the patients freedom to live almost normal lives.
Reference: 1. BIVIGAM Prescribing Information. Biotest Pharmaceuticals Corporation, 2012.
2. IDF - Treatment Experiences and Preferences among Patients with Primary Immunodeficiency
Disease, National Survey of Patients:2008
3. Biotest Pharmaceuticals Corporation. Data on File.
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.