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Safety

In a 52-week, prospective, open-label, single-arm, multicenter, phase 3 study (n=63) of adult and pediatric patients with PI.1

  • Seven patients (11.1%) experienced 11 serious adverse reactions1
    • 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)1

Most common adverse reactions reported in a study of 63 patients receiving BIVIGAM

Adverse Reactions No. Patients Reporting Adverse Reactions (%)
At least 1 adverse reaction 59 (94%)
Headache 32 (51%)
Sinusitis 24 (38%)
Fatigue 18 (29%)
Upper respiratory tract infection 16 (25%)
Diarrhea 13 (21%)
Cough 14 (22%)
Bronchitis 12 (19%)
Pyrexia 12 (19%)
Nausea 9 (14%)

  • 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 lethargy1
  • 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 cycles1
  • The total number of adverse reactions was 431 (a rate of 0.58 ARs per infusion)1

Adverse reactions within 72 hours after the end of a BIVIGAM infusion in ≥5% of patients1

Adverse Reactions No. of Patients Reporting Adverse Reactions
(% of Patients)
[n=63]
No. Infusions with Adverse Reactions
(% of Infusions)
[n=746]
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 5 (8%) 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.

References:

1BIVIGAM Prescribing Information. Boca Raton, FL: ADMA Biologics; 2019.

Important Safety Information for BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid]

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 (SCID).

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 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.

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.

Thrombosis may occur following treatment with 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, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, administer BIVIGAM at the minimum dose and infusion rate practicable.

In patients at risk of developing acute renal failure, renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output need to be monitored.

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.

Passive transfer of antibodies with IGIV treatment may yield positive serological testing results, with the potential for misleading interpretation.

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 subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, 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 or call 1-800-FDA-1088.

For more information about BIVIGAM, please see full Prescribing Information.