Venofer® iron sucrose injection, USP Millions Prescribed.
Millions Treated.®


Effective iron management across the dialysis spectrum

Improving Hb and iron stores in adult HDD and PDD patients

Venofer improves hemoglobin (Hb) without increasing epoetin requirements in HDD-CKD1,2

After a 1 g total treatment course1

Days after initiating iron therapy

*Denotes statistically significant change from baseline (P<.05).

Primary end point achieved

  • 78% (60/77) (95% CI, 68.5 to 87.3) attained target Hb level >11.0 g/dL at 1 or more intervals within 5 weeks after completing Venofer therapy

Venofer improves iron status in HDD-CKD1,2

Improvement in iron status1

Days after initiating iron therapy

Days after initiating iron therapy

*Denotes statistically significant change from baseline (P<.05).

After a 1 g total treatment course

  • Significant increases in: transferrin saturation (TSAT), serum ferritin, serum iron
  • Significant decrease in total iron-binding capacity (TIBC)

Venofer improves anemia and iron indices in HDD patients intolerant to other intravenous iron dextran and/or ferric gluconate1-3

Improved anemia and iron indices1

Days after initiating iron therapy

Days after initiating iron therapy

In iron deficient HDD patients with intravenous iron dextran intolerance after a 1 g total treatment course:

  • Statistically significant increases in mean Hb, hematocrit, serum ferritin, and TSAT were observed from baseline to end of treatment (day 24)

Although epoetin doses decreased slightly, the difference from baseline did not reach statistical significance.

Venofer replenishes iron stores and increases Hb in PDD patients4

Peak Hb increase was higher in patients receiving Venofer plus ESA than in patients treated with ESA alone

Cumulative response—percentage of patients achieving change in Hb≥1.0 g/dL1

Time after initiating treatment (days)

Change in TSAT

Time after initiating treatment (days)

Change in ferritin

Time after initiating treatment (days)

  • + = between treatment groups
  • *,*** = within treatment groups

Less anemia intervention for Venofer PDD-CKD patients4

Anemia intervention occurred later and less often for Venofer treated patients*

Time to anemia intervention

Time (days)

Time (days)

  • *Anemia intervention defined as an increase in ESA dose, administration of nonprotocol intravenous iron or red blood cell transfusion.
  • Results shown are for the ITT population (N=104)


Venofer (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).


Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer. Hypotension following administration of Venofer may be related to rate of administration and/or total dose delivered.

Venofer is contraindicated in patients with known hypersensitivity to Venofer. Do not administer to patients with evidence of iron overload.

In multi-dose efficacy studies in hemodialysis dependent (HDD)–CKD patients (N=231), the most frequent adverse events (>2%) whether or not related to Venofer administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%), hypertension (6.5%), chest pain (6.1%), pain in extremity (5.6%), and diarrhea (5.2%).

In the study of peritoneal dialysis dependent (PDD)-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer, reported by ≥2% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract infections, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer treated patients (27/47) receiving 0.5 mg/kg Venofer experienced a treatment–emergent adverse reaction, 11% of which were serious. The most common treatment–emergent adverse reactions (>2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).

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