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Flebogamma® DIF has proven tolerability and is an efficacious therapeutic option for treating patients with primary immune deficiency (PID)

Proven efficacy in PID1,2

Flebogamma® DIF has demonstrated efficacy in PID with a rate of serious bacterial infections/patient/year well below the acceptance criterion for IVIG effectiveness of ≤1.0 (FDA standard)1,2

Flebogamma DIF Acceptance Criteria

Proven tolerability in PID1,2

In the clinical trial of Flebogamma® DIF 5% in PID, more than 700 infusions were administered1

Approximately 10% of these infusions were associated with adverse events (AEs); the majority of them were mild to moderate in intensity and resolved in the physician's office1

Flebogamma DIF Adverse Events

The most common infusion-related AEs were headache, fever, injection site reactions, diarrhoea, and rigors1

In the clinical trial of Flebogamma® DIF 10% in PID, more than 600 infusions were administered2. The majority of AEs suspected to be treatment-related were graded as mild to moderate in intensity2

Flebogamma DIF Adverse Reactions

The most common (reported by >10% of subjects) potentially treatment-related adverse events were headache, rigors, fever, tachycardia, hypotension, back pain, and myalgia. No serious treatment-related AEs occurred2

In patients with risk factors, tolerability is particularly important

In a recent prospective study, which included patients with immunodeficiency, autoimmune disease and bone marrow transplant (BMT), both Flebogamma® DIF 5% and 10% were well tolerated3

Table Tolerability

Frequency of infusions with potentially treatment-related AEs with Flebogamma® DIF 5% was low (2.2%) and no headaches were reported3

Percentage and type of Flebogamma® DIF 10% AEs reported in this study fell well within the ranges of AEs reported in other IVIG clinical studies3

Flebogamma® DIF 5% may be an appropriate choice for many of your patients including those who cannot tolerate a 10% IVIG3

inprimary-references

References:

  1. Berger M, Flebogamma 5% DIF. Investigators. A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency diseases (PID) patients of Flebogamma 5% DIF, the next generation of Flebogamma. J Clin Immunol. 2007;27(6):628-633.
  2. Berger M, Pinciaro PJ, Althaus A, et al. Efficacy, pharmacokinetics, safety, and tolerability of Flebogamma 10% DIF, a high-purity human intravenous immunoglobulin, in primary immunodeficiency. J Clin Immunol. 2010;30(2):321-329.
  3. Alsina L, Mohr A, Montañés M, et al. Surveillance study on the tolerability and safety of Flebogamma® DIF (10% and 5% intravenous immunoglobulin) in adult and pediatric patients. Pharmacol Res Perspect. 2017 Oct;5(5).