--- title: Product Characteristics | BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] description: See how BIVIGAM design and development follow ADMA Biologics' commitment to continuity of care and devotion to patients. See Safety & Prescribing Info --- ## 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 ![Photo of man and dog](https://www.bivigam.com/hs-fs/hubfs/GettyImages-1347488265.png-1.png?width=916&height=240&name=GettyImages-1347488265.png-1.png) # Product Characteristics & Commitment ## HIGH-QUALITY IVIG YOU CAN COUNT ON — IN EVERY VIAL WITH PRODUCT CHARACTERISTICS THAT ADDRESS YOUR PATIENTS’ UNIQUE NEEDS1 --- ![Icon for no added sugars](https://www.bivigam.com/hubfs/no%20sugar.svg "Icon for no added sugars") NO ADDED SUGARS (INCLUDING NO SUCROSE OR GLUCOSE) ![Icon for no added preservatives](https://www.bivigam.com/hubfs/no%20preserves.svg "Icon for no added preservatives") NO ADDED  PRESERVATIVES ![Icon for stabilized and buffered with glycine](https://www.bivigam.com/hubfs/glycine.svg "Icon for stabilized and buffered with glycine") STABILIZED AND BUFFERED WITH GLYCINE (NO GLUCOSE OR PROLINE STABILIZERS) ![Icon for no latex](https://www.bivigam.com/hubfs/no%20latex.svg "Icon for no latex") NO LATEX #### Storage - Once vial is entered, use promptly - Store at 2-8 °C (36-46 °F) for up to 36 months from the date of manufacture - Do not freeze - Product may be stored up to 4 weeks at ≤ 25°C (77°F). After storage at room temperature product must be used or discarded #### ADMA is committed to excellence when producing specialty plasma-derived products - **Fully validated and qualified processes:** ensure consistent safety, efficacy, purity, and potency that meet FDA CFR criteria for IVIG - **Commitment to cGMP compliance:** demonstrates ongoing adherence to the most stringent code of federal regulations ### Our devotion to underserved patient populations and hands-on approach to quality is our guiding principle FDA=US Food and Drug Administration; CFR=Code of Federal Regulations; cGMP=current good manufacturing practices. ## ADMA IS COMMITTED TO CONTINUITY OF CARE TO ENSURE CONSISTENT SUPPLY THAT MEETS THE DEMANDS OF THE PI COMMUNITY ADMA BIOLOGICS IS THE ONLY US-DOMICILED PRODUCER OF PLASMA-DERIVED THERAPEUTICS --- ![Icon for production releases](https://www.bivigam.com/hubfs/Layer_1.svg "Icon for production releases") ![Layer_1](https://www.bivigam.com/hubfs/Layer_1.svg "Layer_1") ROUTINE AND ROBUST PRODUCT RELEASES consistent, reliable, and uninterrupted raw material supply ![Icon for scale](https://www.bivigam.com/hubfs/Layer_12.svg "Icon for scale") ![Layer_12](https://www.bivigam.com/hubfs/Layer_12.svg "Layer_12") EXPANDED PRODUCTION SCALE provides more IVIG supply than ever before ![Icon for vial sizes](https://www.bivigam.com/hubfs/Layer_13.svg "Icon for vial sizes") ![Layer_13](https://www.bivigam.com/hubfs/Layer_13.svg "Layer_13") 5 G AND 10 G VIAL SIZES provide increased flexibility and convenient administration ![Icon for fill-finish](https://www.bivigam.com/hubfs/Layer_14.svg "Icon for fill-finish") ![Layer_14](https://www.bivigam.com/hubfs/Layer_14.svg "Layer_14") IN-HOUSE FILL-FINISH capabilities add to complete end-to-end control of critical manufacturing functions ![Icon for collection centers](https://www.bivigam.com/hubfs/Layer_15.svg "Icon for collection centers") ![Layer_15](https://www.bivigam.com/hubfs/Layer_15.svg "Layer_15") ADMA OPERATES 7 STATE-OF-THE-ART PLASMA COLLECTION CENTERS to ensure we meet the demands of the patients we serve ### To meet growing demand, ADMA Biologics has end-to-end control of critical manufacturing functions, expanded production scale, and fill-finish, and has built a state-of-the art plasma collection network FDA=US Food and Drug Administration; CFR=Code of Federal Regulations; cGMP=current good manufacturing practices. **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.