The Flebogamma® DIFference

Flebogamma® DIF is a highly purified IVIG with trace amounts of immunoglobulin A (IgA) and sodium, making it suitable for patients with certain risk factors

  • Osmolality, sodium, sugar, and IgA content affect the clinical tolerability in your patients. Choose the right product based on your patients' needs:
    • Hyperosmolar solutions administered intravenously may cause fluid shifts leading to hemodynamic changes, thromboembolic incidents, or renal complications1
    • Low sodium preparations make it appropriate for patients with restricted sodium intake; higher incidences of adverse events and thromboembolic complications may be seen with increased salt concentrations2
    • Sugar content may be linked to adverse events, including renal failure or insufficiency; as many as 90% of IVIG-associated renal adverse events have been associated with products containing sucrose2
    • Patients with selective IgA deficiency may be at risk for developing anti-IgA antibodies2,3
Table IVIG Product Characteristics Table IVIG Product Characteristics

Flebogamma® DIF is a highly purified IVIG with high functional integrity of the IgG molecule4

  • Flebogamma® DIF:
    • Is preservative-free
    • Has osmolality within the normal physiological range (240-370 mOsm/kg)5
    • Contains trace amounts of sodium (<3.2 mmol/l)6
    • Uses sorbitol as stabiliser (no sucrose, no maltose, and no glucose)5
    • Is one of the IVIGs with the lowest concentrations of IgA (trace amounts)*,6

*Mean values (mg/ml):
Flebogamma® DIF 5%: 0.0032±0.002, n=277
Flebogamma® DIF 10%: 0.0031±0.0003, n=114

 
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References:

  1. Shah S. Pharmacy considerations for the use of IGIV therapy. Am J Health Syst Pharm. 2005;62(16 Suppl 3):S5-S11.
  2. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6(4):592-599.
  3. NIH consensus conference. Intravenous immunoglobulin. Prevention and treatment of disease. JAMA. 1990;264(24):3189-3193.
  4. Data on file. Instituto Grifols, S.A.
  5. Flebogamma® DIF EU SmPC.
  6. Siegel J. Immune globulins: therapeutic, pharmaceutical, cost, and administration considerations. Pharmacy Practice News. Special Edition, Educational Reviews. January 2014.
  7. Ochs HD, Siegel J. Stabilizers used in intravenous immunoglobulin products: a comparative review. Pharmacy Practice News. Special Report. August 2010.