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Adverse reactions (ARs) within 72 hours after the end of a BIVIGAM infusion in ≥5% of patients2

Adverse reactions
No. of patients reporting adverse reactions
(% of patients)
No. of infusions with adverse reactions
(% of infusions)
Headache 27 (43%) 115 (15.4%)
Fatigue 15 (24%) 59 (7.9%)
Infusion-site reaction 5 (8%) 5 (0.7%)
Nausea 5 (8%) 8 (1.1%)
Sinusitis 5 (8%) 5 (0.7%)
Blood pressure increased 4 (6%) 5 (0.7%)
Diarrhea 4 (6%) 4 (0.5%)
Dizziness 4 (6%) 4 (0.5%)
Lethargy 4 (6%) 4 (0.5%)
Back pain 3 (5%) 3 (0.4%)
Blood pressure diastolic decreased 3 (5%) 5 (0.7%)
Fibromyalgia* 3 (5%) 17 (2.3%)
Migraine 3 (5%) 8 (1.1%)
Myalgia 3 (5%) 4 (0.5%)
Pharyngolaryngeal pain 3 (5%) 3 (0.4%)

*Symptoms occurring under preexisting fibromyalgia.

  • The total number of ARs was 431 (a rate of 0.58 ARs per infusion)
  • Fifty-nine patients (94%) had an adverse reaction at some time during the study. The proportion of patients who had at least one adverse reaction was the same for both the 3- and 4-week cycles2
  • The most common adverse reactions to BIVIGAM (reported in >5% of patients in clinical study) were headache, fatigue, infusion-site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy2
  • Seven patients (11.1%) experienced 11 serious adverse reactions2
      • Two of these were related serious adverse reactions (vomiting and dehydration) that occurred in 1 patient

  • One patient withdrew from the study due to treatment-related adverse reactions (lethargy, headache, tachycardia, and pruritus)2


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®


  • 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.
References: 1. Wasserman RL. A new intravenous immunoglobulin (BIVIGAM®) for primary humoral immunodeficiency. Expert Rev Clin Immunol. 2014;10(3):325-337. 2BIVIGAM Prescribing Information. ADMA Biologics; 2022. 

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