No dextran or modified dextran
No test dose required

Venofer® (iron sucrose injection, USP) is used intravenously to replenish body iron stores in patients with iron deficiency anemia. Venofer® is an iron replacement product indicated in the treatment of iron deficiency anemia in adult and pediatric patients 2 years and older with chronic kidney disease (CKD)1

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

Non-dextran Formula
Venofer® is a brown, sterile, aqueous complex of polynuclear iron (III)-hydroxide in sucrose containing 20 mg elemental iron per mL. It contains no dextran or modified dextran.

A Test Dose Is Not Required
Unlike iron dextran products, Venofer® does not require a test dose prior to therapy. Staff vigilance when administering any intravenous iron product is recommended.

Over 50 Years of Worldwide Clinical Experience
More than 100 clinical studies and a long history of the use of iron sucrose injection worldwide have established the efficacy and safety of Venofer® in patients with iron deficiency anemia from CKD.2-125 Between 1992 and February 2012, over 13 million patients have been treated with more than 260 million units (100 mg equivalents) in more than 84 countries.2

Large Safety Database
A large safety database on Venofer® (iron sucrose injection, USP) is available from clinical trial reports, publications, and post-marketing surveillance.

Data on the safety of Venofer® have been collected since its introduction to the European market (Switzerland) in 1950 and during a modern clinical development program begun in 1992. Serious hypersensitivity reactions, including anaphylactic type reactions, some of which have been life-threatening and fatal, have occurred with Venofer®.1 See Important Safety Information below.

Administration
Venofer® may be dosed in the office or outpatient setting. It may be administered either by undiluted IV push injection or IV infusion. This option gives healthcare providers the flexibility to deliver iron therapy in the most convenient way for the patient.

Convenient Single-use Vials
Venofer® is available in 50 mg/2.5 mL, 100 mg/5 mL and 200 mg/10 mL single use vials. One 5-mL vial of Venofer® provides 100 mg of elemental iron as iron sucrose, the National Kidney Foundation-Kidney Dialysis Outcomes Quality Initiative (NKF-KDOQI) recommended dose for a single dialysis session in adult CKD patients.126 Each vial is barcoded with its National Drug Code (NDC) to help prevent medication errors.






For more complete information about Venofer® (iron sucrose injection, USP) you may view and download the Formulary Monograph here.







*Based on IMS Health, IMS National Sales Perspective™ (October 2012) 3rd quarter 2012 results-dollar volume ($) and units (100 mg equivalents).



 






IMPORTANT SAFETY INFORMATION

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 total dose delivered.

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

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance (7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (> 5%) 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-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer® administration, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, 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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Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
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