Venofer® (iron sucrose injection, USP) is a brown, sterile, aqueous complex of polynuclear
iron (III)-hydroxide in sucrose for intravenous use. It contains no preservatives
or dextran polysaccharides. Venofer® is indicated in the treatment of iron deficiency
anemia in non-dialysis dependent chronic kidney disease (CKD) patients
receiving or not receiving an erythropoietin and in hemodialysis or peritoneal dialysis
dependent chronic kidney disease patients receiving an erythropoietin.1
• Over 50 years of worldwide clinical experience2
Venofer® is used to replenish body iron stores in patients with iron deficiency anemia.
Clinical trials and the long history of the use of iron sucrose injection worldwide
has established the efficacy and safety of this drug in patients with iron deficiency
anemia from chronic renal failure. Since 1992, over 90 million doses (100mg
equivalents) have been sold in 79 countries.
The clinical evaluation of Venofer® is based on results from more than 100 studies3-
124 involving more than 7,000 subjects. More than 5,000 patients were treated with
Venofer®. These studies demonstrate the effectiveness of Venofer® in the treatment
of iron deficiency anemia alone and in combination with an erythropoietin.
• Large safety database
A large safety database on Venofer® is available from clinical trial reports,
publications, and postmarketing surveillance.
Data on the safety of Venofer® has been collected since its introduction to the
European market (Switzerland) in 1950 and during a modern clinical development
program begun in 1990. These data, and the data observed in worldwide postmarketing
surveillance, suggest that most adverse events are mild to moderate and
similar to those seen in patients with chronic renal failure not receiving intravenous
iron.1
• Serious adverse reactions related to Venofer are uncommon
The incidence of serious adverse reactions is low. Clinical trials presented to
the U.S. Food and Drug Administration supporting the safety and efficacy of
Venofer® were conducted in 1,496 patients.11-13,23-24,92,123,124 Based on an estimated use
in 4.6 million patients that received Venofer® worldwide between 1992 and August
2005, only 108 hypersensitivity reactions have been reported, including serious or
life threatening reactions.2
• Contains no dextran polysaccharides
Venofer® (iron sucrose injection, USP) contains no dextran polysaccharides, which
are associated with antibody-induced anaphylaxis to iron dextran.
• Indicated for the treatment of iron deficiency anemia in hemodialysis,
peritoneal dialysis, and non-dialysis dependent CKD patients
Venofer® (iron sucrose injection, USP) is indicated in the treatment of iron deficiency
anemia in non-dialysis dependent-CKD patients receiving or not receiving an
erythropoietin and in hemodialysis and peritoneal dialysis dependent-CKD patients
receiving an erythropoietin.1
• Safely administered to hemodialysis patients intolerant to other IV
iron products
In four US Clinical trials in hemodialysis-dependent CKD patients, a total of 130
patients who were intolerant to other IV iron products (109 intolerant to iron dextran
alone, 6 intolerant to ferric gluconate alone, 15 intolerant to both) were successfully
treated with Venofer®. There were no discontinuations or serious adverse drug
reactions. A total of 8 patients experienced one or more non-serious related
adverse events. The most common were taste disturbance (4) and nausea (3).125
• 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 IV iron products. Hypotension
has been reported frequently in hemodialysis dependent-CKD patients receiving IV
iron, and has also been reported in non-dialysis and peritoneal dialysis dependent-
CKD patients receiving IV iron. Hypotension following administration of Venofer®
may be related to rate of administration and total dose delivered.
In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the
most frequent adverse events (>5%), whether or not related to Venofer® (iron
sucrose injection, USP) administration, were hypotension, cramps/leg cramps, nausea,
headache, graft complications, vomiting, dizziness, hypertension, chest pain
and diarrhea. In post-marketing safety studies in hemodialysis dependent-CKD
patients (N=1,051), the most frequent adverse events reported (>1%) were congestive
heart failure, sepsis and taste perversion. In multi-dose efficacy studies in nondialysis
dependent-CKD patients (N=91), the most frequent adverse events (>5%)
whether or not related to Venofer® administration, were taste disturbance, peripheral
edema, diarrhea, constipation, nausea, dizziness, and hypertension. In the study of
peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse
events, whether or not related to Venofer®, reported by >5% of these patients were
diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema
and nausea.
• Convenient single dose vials, preservative free
The difficulties associated with glass ampules, such as breakage, splintering, and
bodily injury to staff, have been eliminated. One 5 mL vial of Venofer® provides 100
mg of iron as iron sucrose, the NKF-K/DOQI recommended dose for a single dialysis
session. Venofer® contains no preservatives such as benzyl alcohol. Each
Venofer® vial is bar coded with its National Drug Code to help prevent medication
errors.
• Administered by slow injection or by infusion
Venofer® is simple to administer. Venofer® may be administered either by undiluted
IV push injection or by IV infusion1. This option gives healthcare providers the flexibility
to deliver iron therapy in the most convenient way for the patient.
• A test dose is not required
Venofer®, unlike iron dextran products, does not require a test dose prior to initiation
of therapy.11,12 However, in two US clinical trials in hemodialysis patients, some
patients received a test dose at the physician’s discretion.
• Non Dialyzable
Results of an in vitro study found that Venofer® was not significantly removed by
either high efficiency or high flux dialyzers.
• Dissociated by reticuloendothelial system (RES)
Following Venofer® administration, the iron sucrose complex of Venofer® is picked
up from the circulation and dissociated by the reticuloendothelial system (RES)1.
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