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  Iron Deficiency
  Chronic Renal Failure
  Managing Iron Deficiency Anemia
  Key Learnings

Clinical Efficacy and Safety

Since Venofer® (iron sucrose injection, USP) was first approved in Switzerland in 1950, a large body of evidence in the form of study reports and publications has been produced that demonstrates the safety and efficacy of intravenous iron sucrose. The clinical evaluation of Venofer® is based on results from 86 studies1-86 involving approximately 5773 subjects. More than 5000 patients were treated with Venofer® in these studies. The results demonstrate that Venofer® is effective therapy for the treatment of iron deficiency anemia in patients receiving erythropoietin and for iron deficiency such as occurs during erythropoietin therapy. The incidence of serious adverse reactions is low. Clinical trials submitted to the US Food and Drug Administration support the safety of Venofer® (1282 patients).9-11,21,22 Based on use in an estimated 2 million patients that received Venofer® worldwide between 1992 and 2002, only 83 hypersensitivity reactions have been reported, including serious or life threatening reactions. Venofer® is well tolerated in the vast majority of patients, including those with a history of anaphylactoid reactions to iron dextran. Venofer® is easy to administer either as a slow injection or as an infusion. A test dose is not required.

Review of Selected Clinical Trials in End-Stage Renal Disease (Chosen From 86 Studies)

Study A10,87
Study A was a multicenter, open-label, historically controlled study in 101 hemodialysis patients (77 patients with Venofer® (iron sucrose injection, USP) treatment and 24 in the historical control group) with iron deficiency anemia. Eligibility for Venofer® treatment included patients undergoing chronic hemodialysis 3 times weekly, receiving erythropoietin, hemoglobin concentration greater than 8.0 and less than 11.0 g/dL for at least 2 consecutive weeks, transferrin saturation <20%, and serum ferritin <300 ng/mL. The erythropoietin dose was to be held constant throughout the study. The protocol did not require administration of a test dose; however, some patients received a test dose at the physician’s discretion. Exclusion criteria included significant underlying disease, asthma, active inflammatory disease, or serious bacterial or viral infection. Venofer® 5 mL (one vial) containing 100 mg of elemental iron was administered through the dialysis line at each dialysis session either as a slow injection or a saline-diluted slow infusion for a total of 10 dialysis sessions with a cumulative dose of 1000 mg elemental iron. A maximum of 3 vials of Venofer® was administered per week. No additional iron preparations were allowed until after the day 57 evaluation. The mean change in hemoglobin from baseline to day 24 (end of treatment), day 36, and day 57 was assessed.

  • Four of the 77 patients (5%) had 6 adverse events believed to be related to Venofer®, including diarrhea (2 patients), abdominal pain, nausea, constipation, and taste perversion
  • No hypersensitivity reactions were seen, including in any of 10 patients who had shown previous intolerance/allergy to iron dextran

The historical control population consisted of 24 patients similar to patients treated with Venofer® (iron sucrose injection, USP) who were off intravenous iron for at least 2 weeks and who had received erythropoietin therapy with hematocrit averaging 31% to 36% for at least 2 months prior to study entry.87 Patient age and serum ferritin level were similar between treatment and historical control patients. The mean baseline hemoglobin and hematocrit were higher, and the erythropoietin dose was lower in the historical control population than in the Venofer®-treated population.

  • Patients in the Venofer®-treated population showed a statistically significantly greater increase in hemoglobin and hematocrit than did patients in the historical control population
      • —At the 2-week follow-up, patients in the Venofer®-treated population showed a significantly (P<.01) greater increase in hemoglobin (1.3 g/dL) and hematocrit (3.6%) than did patients in the historical control population (Hb, -0.6 g/dL; Hct, -1.2%)
      —At the 5-week follow-up, Venofer®-treated patients showed a significantly (P<.05) greater increase in hemoglobin (1.2 g/dL) than did patients in the historical control group (-0.1 g/dL)
      —At the end of treatment, patients in the Venofer®-treated population showed a significantly (P<.01) greater increase in hemoglobin (1.0 g/dL) and hematocrit (3.1%) than did patients in the historical control group (Hb, 0 g/dL; Hct, -0.3%)
  • Serum ferritin increased significantly (P=.001) at endpoint of study from baseline in the Venofer®-treated population (165.3 ng/mL) compared with the historical control population (-27.6 ng/mL). Transferrin saturation also increased significantly (P=.0016) at endpoint of study from baseline in the Venofer®-treated population (8.8%) compared with the historical control population (-5.1%)

The authors concluded that doses of 100 mg Venofer® (iron sucrose injection, USP) given IV in 10 consecutive dialysis sessions for a total dose of 1000 mg were effective and safe in dialysis patients with iron deficiency anemia receiving supplemental erythropoietin therapy.

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Study B11
The safety and efficacy of Venofer® (iron sucrose injection, USP) in hemodialysis patients who had experienced intolerance to iron dextran were also examined in a single-arm, 2-period, open-label, multicenter study by Van Wyck et al. Sixteen patients with Hb <11 g/dL and a history of mild reactions and 7 patients with a history of severe anaphylactoid reactions to iron dextran were included. Following an observation period, patients received 100 mg Venofer® either by intravenous injection or infusion for 10 consecutive dialysis sessions over 3 to 4 weeks. A test dose was not required; however, some patients received a test dose at the physician’s discretion. Since the study was primarily a safety study, efficacy assessments were limited to changes from baseline to day 24 (end of treatment evaluation).

  • There were no hypersensitivity 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 iron sucrose were reported in 2 patients:
      • —Taste perversion (metallic taste, 1 patient twice)
      —Pruritus (1 patient)
  • Mean hemoglobin increased from 10.4 g/dL to 11.5 g/dL at day 24 (P<.05, increase of 11.0%)
  • Mean hematocrit increased from 32.8% to 36.4% at day 24 (P<.05, increase of 11.0%)
  • MCV, MCHC, serum iron, TSAT, and serum ferritin also increased significantly, and total iron binding capacity (TIBC) decreased significantly

The authors concluded that Venofer® is safe and effective in the management of anemia in hemodialysis patients receiving supplemental erythropoietin sensitive to iron dextran and can be administered without a test dose by IV push or infusion.

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Study C9
A study of the safety and efficacy of Venofer® (iron sucrose injection, USP) or the combination of Venofer® and erythropoietin was performed in an open, single-arm, 2-period, multicenter study by Van Zyl-Smit et al in South Africa. One hundred thirty-one patients were enrolled. All suffered from hemodialysis-associated anemia, were undergoing maintenance hemodialysis (2 to 3 sessions per week), had an Hb ≤10.0 g/dL, serum transferrin saturation ≤20%, and serum ferritin ≤200 ng/mL. A first dose of 50 mg of Venofer® was administered at the first hemodialysis session, followed by doses of 100 mg of iron during dialysis 3 times weekly until an individually calculated dose, based upon baseline hemoglobin and body weight, was administered. Patients were then followed for an additional 4 weeks, in a no-treatment observation period.

The modified intent-to-treat population consisted of 130 patients. Mean hematologic and iron parameters at baseline and following treatment with Venofer® (iron sucrose injection, USP) are given below:

  • Mean hemoglobin increased from 7.2 g/dL to 9.0 g/dL at observation week 2 and 9.2 g/dL at observation week 4 (P<.0001, maximum increase of 28%)
  • Mean hematocrit increased from 22.5% to 27.9% at observation week 2 and 28.5% at observation week 4 (P<.0001, maximum increase of 27%)
  • Mean serum ferritin increased from 65.1 ng/mL to 512.7 ng/mL at observation week 2 and 440.2 ng/mL at observation week 4 (P<.0001, maximum increase of 687%)
  • Mean serum transferrin saturation increased from 11.4% to 27.7% at observation week 2 and 27.6% at observation week 4 (P<.0001, maximum increase of 143%)

Adverse events (>1%) that were reported to be possibly related to Venofer® were hypotension (13%), nausea (3%), increased liver function test (2%), pneumonia (2%), and vomiting (2%). Hypotension was also associated with hemodialysis itself and occurred with similar frequency during the treatment period and during the observation period when no iron was given.

The authors concluded that Venofer® was safe and effective in the treatment of patients with hemodialysis-associated anemia.

Postmarketing Safety Study 121
Six hundred sixty-five (665) chronic hemodialysis patients were treated with Venofer® (iron sucrose injection, USP) doses of 100 mg at each dialysis session for up to 10 consecutive sessions for their iron deficiency or on a weekly basis for 10 weeks for maintenance of iron stores. A total of 8583 doses of iron were administered. Eighty (80) patients with previous intolerance to other IV iron products (63 iron dextran, 5 ferric gluconate, 12 both) were included. There were no drug-related deaths, serious adverse drug reactions, or withdrawals due to serious adverse reactions. There were 2 nonserious adverse reactions reported (constipation 1, pruritus 1). Prior history of IV intolerance did not affect adverse drug reaction rates.

Postmarketing Safety Study 222
Three hundred eighty-six (386) patients were exposed to a single dose of Venofer® 100 mg IV by slow injection over 2 minutes or 200 mg IV by slow injection over 5 minutes. No study drug-related serious adverse events (SAEs) were reported. Three patients experienced unrelated SAEs during the study. Two patients experienced adverse events that led to premature discontinuation from the study. No anaphylactic reactions were observed during the study. History of iron intolerance had no impact on the occurrence of adverse events. Only 1 patient with a history of iron intolerance reported a transient taste disturbance.

IMPORTANT SAFETY INFORMATION
Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Hypersensitivity reactions have been reported with injectable iron products. Hypotension has been reported frequently in patients receiving intravenous iron. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered. In multidose efficacy studies (N=231), the most frequent adverse events, whether or not related to Venofer® administration, were hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. In postmarketing safety studies (N=1051), the most frequent adverse events reported (>1%) were congestive heart failure, sepsis, and taste perversion.
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