--- title: Healthcare Professional Site for BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] description: See dosing, clinical data, and support program for BIVIGAM, an IVIG for the treatment of primary humoral immunodeficiency (PI). See Safety & Prescribing Info image: https://www.bivigam.com/hubfs/OG%20image.png --- ## You are leaving this site! By clicking YES, you will be directed to another website. Click NO to remain on this page. Do you wish to continue to another website? Yes No ![BIVIGAM-Logo-1](https://www.bivigam.com/hubfs/BIVIGAM-Logo-1.svg) This information is intended for US audiences only. [ I AM A HEALTHCARE PROFESSIONAL ](https://www.bivigam.com#) [ I AM A PATIENT ](https://www.bivigam.com/home-patient) ![Variant3](https://www.bivigam.com/hs-fs/hubfs/Variant3.png?width=591&height=160&name=Variant3.png)   #### Brought to you by ADMA Biologics, BIVIGAM® is by your side, providing continuity of care with high-quality IVIG you can count on. ![Icon showing medical protection](https://www.bivigam.com/hubfs/Protection%20-%20icon.svg) ## HOW DOES BIVIGAM DOSING WORK?** **GET INFORMATION ON DOSING, ADMINISTRATION AND STORAGE. [![View Dosing](https://no-cache.hubspot.com/cta/default/23624991/35b1135c-575d-4a47-a74d-40c7d559a1d8.png)](https://cta-redirect.hubspot.com/cta/redirect/23624991/35b1135c-575d-4a47-a74d-40c7d559a1d8) ## IS BIVIGAM THE RIGHT TREATMENT FOR YOUR PATIENTS WITH PRIMARY HUMORAL IMMUNODEFICIENCY (PI)? --- #### Learn how it provides proven protection1 [![Discover Bivigam](https://no-cache.hubspot.com/cta/default/23624991/f4b07a38-b14d-4b0c-9e1b-add48a53bec1.png)](https://cta-redirect.hubspot.com/cta/redirect/23624991/f4b07a38-b14d-4b0c-9e1b-add48a53bec1) ![Photo of woman and dog](https://www.bivigam.com/hs-fs/hubfs/Mask%20group-1.png?width=1136&height=574&name=Mask%20group-1.png) ![Logo for ADMA ADvantage Ig Patient Support Program | Simplify Access to Treatment](https://www.bivigam.com/hubfs/home-ADvantage_ccallout-desk.svg "Logo for ADMA ADvantage Ig Patient Support Program | Simplify Access to Treatment") ![Group 52 (1)](https://www.bivigam.com/hubfs/Group%2052%20(1).png "Group 52 (1)") ## SIMPLIFY ACCESS TO BIVIGAM FOR YOUR PATIENTS --- When you decide that IGIV treatment is right for your patient, enroll them in the support program that can help connect them with potential financial assistance. ![home-ADvantage_ccallout-mob](https://www.bivigam.com/hubfs/home-ADvantage_ccallout-mob.svg "home-ADvantage_ccallout-mob") [![View Support](https://no-cache.hubspot.com/cta/default/23624991/72f63233-f62e-4323-8763-7572f23c1ba9.png)](https://cta-redirect.hubspot.com/cta/redirect/23624991/72f63233-f62e-4323-8763-7572f23c1ba9) [![View Support](https://no-cache.hubspot.com/cta/default/23624991/09deafa8-253b-41b6-a72f-fafa67955109.png)](https://cta-redirect.hubspot.com/cta/redirect/23624991/09deafa8-253b-41b6-a72f-fafa67955109) **Indication**   BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older with 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 (SCID). **Important Safety Information for BIVIGAM®** 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 central vascular catheters, hyperviscosity and cardiovascular risk factors. - Use of immune globulin intravenous (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs. - 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. **Contraindications** BIVIGAM is contraindicated in: - Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - IgA deficiency patients with antibodies to IgA and a history of hypersensitivity. **Warnings and Precautions** Thrombosis may occur following treatment with immune globulin (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 and ensure adequate hydration before administration. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Severe hypersensitivity reactions may occur with IGIV products, including BIVIGAM. In case of hypersensitivity, discontinue BIVIGAM infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for treatment of acute hypersensitivity reactions. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Acute renal dysfunction/failure, osmotic nephrosis, and death may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering BIVIGAM. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of BIVIGAM and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing BIVIGAM. In at-risk patients, administer BIVIGAM at the minimum infusion rate practicable. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV treatment, including BIVIGAM. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events. Aseptic meningitis syndrome (AMS) may occur with IGIV treatments, including BIVIGAM. AMS usually begins within several hours to 2 days following IGIV treatment. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination on patients exhibiting signs and symptoms of AMS, including cerebrospinal fluid (CSF) studies, to rule out other causes of meningitis. IGIV products, including BIVIGAM, may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for clinical signs and symptoms of hemolysis, including appropriate confirmatory laboratory testing. Noncardiogenic pulmonary edema may occur in patients following IGIV treatment, including BIVIGAM. Transfusion-Related Acute Lung Injury (TRALI) is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours following treatment. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and the patient’s serum. TRALI may be managed using oxygen therapy with adequate ventilatory support. 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. All infections suspected by a physician to possibly have been transmitted by this product should be reported to ADMA Biologics at 1-800-458-4244. After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. **Pediatric Use** BIVIGAM was evaluated in 25 pediatric patients (3 children ages 2 to <6, 9 children ages 6 to <12, and 13 adolescents ages 12 to 16 years) with PI. The safety and effectiveness of BIVIGAM for the treatment of PI has been established in pediatric patients 2 years of age and older, based on data from 2 prospective, open-label, single-arm, multi-center studies, supported by evidence from a population PK analysis of adult and pediatric PK data. **Adverse Reactions** Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, increased blood pressure, diarrhea, dizziness, and lethargy. You are encouraged to report side effects of prescription drugs to ADMA Biologics at 1-800-458-4244 or the FDA. Visit [www.fda.gov/MedWatch](http://fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program) or call 1-800-FDA-1088. For more information about BIVIGAM, please see [full Prescribing Information.](http://fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program) References: 1. BIVIGAM Prescribing Information. Boca Raton, FL: ADMA Biologics; 2022. 2. Wasserman RL. A new intravenous immunoglobulin (BIVIGAM®) for primary humoral immunodeficiency. *Expert Rev Clin Immunol.* 2014;10(3):325-337. 3. Wasserman RL, Church JA, Stein M, et al. Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency. *J Clin Immunol.* 2012;32(4):663-669.