Intended For US Audiences Only.

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HIGH-QUALITY IVIG YOU CAN COUNT ON — IN EVERY VIAL WITH PRODUCT CHARACTERISTICS THAT ADDRESS YOUR PATIENTS’ UNIQUE NEEDS1


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NO ADDED SUGARS


(INCLUDING NO SUCROSE OR GLUCOSE)

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NO ADDED 
PRESERVATIVES

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STABILIZED AND BUFFERED WITH GLYCINE


(NO GLUCOSE OR PROLINE STABILIZERS)

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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
  • Within the first 24 months of shelf-life, 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


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ROUTINE AND ROBUST PRODUCT RELEASES

consistent, reliable, and uninterrupted raw material supply

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EXPANDED PRODUCTION SCALE

provides more IVIG supply than ever before

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5 G AND 10 G VIAL SIZES

provide increased flexibility and convenient administration

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IN-HOUSE FILL-FINISH

capabilities add to complete end-to-end control of critical manufacturing functions

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ADMA OPERATES 10 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 patients 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, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Use of immunoglobulin intravenous (IVIG) 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 preexisting 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.
Reference: 1. BIVIGAM Prescribing Information. ADMA Biologics; 2022.

Tap for important safety information for BIVIGAM