SAFETY in therapy

Distinct and recognized formulation

Intravenous iron sucrose contains no dextran or modified dextran

  • No test dose required
  • No black box warning
  • Consistently ranked the #1 prescribed intravenous iron since 20031

Well-established profile

  • Long proven safety record with over 60 years of worldwide clinical experience2-5
  • Proven tolerability in adult HDD patients intolerant to iron dextran, ferric gluconate, or both3-5

 

Safety studied in adult HDD patients with prior intolerance to intravenous iron dextran3

The safety and efficacy of Venofer (iron sucrose injection, USP) in HDD patients who had experienced intolerance to iron dextran were examined in a single-arm, two period, open-label, multicenter study. Following an observation period, patients received 100 mg Venofer either by intravenous injection or infusion for 10 consecutive dialysis sessions over 3-4 weeks. A test dose was not required.

Study included 23 HDD patients with ongoing intravenous EPO therapy, Hb <11g/dL, and:

  • 16 patients had a history of mild reactions to iron dextran
  • 7 patients had a history of severe anaphylactoid reactions to iron dextran
  • 11 patients had a history of allergy to at least 1 medication in addition to iron dextran

Adverse drug events (ADEs) and blood pressures were recorded at each of 10 dialysis sessions during which Venofer was administered:

  • Blood pressure was recorded immediately before and at intervals of 15 and 60 minutes after Venofer administration
  • Net blood pressure change was computed, and results were compared with those seen during observation sessions before dialysis and at intervals of 15 and 60 minutes after starting dialysis

Safety results: Venofer was well tolerated3

  • There were no anaphylactic reactions, no serious adverse drug reactions, and no patients discontinued from the study due
    to adverse drug reactions
  • Three mild adverse events considered related or possibly related to Venofer were reported in 2 patients:
       Metallic taste (1 patient with 2 events)
       Pruritus (1 patient)
  • There was no discernible effect on blood pressure during or after Venofer therapy