WARNING
THE PARENTERAL USE OF COMPLEXES OF IRON AND CARBOHYDRATES HAS RESULTED IN ANAPHYLACTIC-TYPE REACTIONS. DEATHS ASSOCIATED WITH SUCH ADMINISTRATION HAVE BEEN REPORTED. THEREFORE, INFeD SHOULD BE USED ONLY IN THOSE PATIENTS IN WHOM THE INDICATIONS HAVE BEEN CLEARLY ESTABLISHED AND LABORATORY INVESTIGATIONS CONFIRM AN IRON DEFICIENT STATE NOT AMENABLE TO ORAL IRON THERAPY. BECAUSE FATAL ANAPHYLACTIC REACTIONS HAVE BEEN REPORTED AFTER ADMINISTRATION OF IRON DEXTRAN INJECTION, THE DRUG SHOULD BE GIVEN ONLY WHEN RESUSCITATION TECHNIQUES AND TREATMENT OF ANAPHYLACTIC AND ANAPHYLACTOID SHOCK ARE READILY AVAILABLE.
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INFED SUMMARY
B1
INFeD®
(IRON DEXTRAN INJECTION USP)
INFeD (iron dextran injection, USP) is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.
Intravenous or intramuscular injections of iron dextran are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.
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NEWS HIGHLIGHTS
Published Studies Related to Infed (Iron Dextran)
Lipid peroxidation products formation with various intravenous iron preparations in chronic kidney disease. [2009]
The role of intravenous iron in contributing to oxidative stress and endothelial dysfunction in chronic kidney disease (CKD) is debatable. The present study assessed differences in fasting plasma malondialdehyde (pMDA) levels 30 minutes before and after intravenous infusion of low molecular weight iron dextran (ID) (n = 19), iron-sucrose (IS) (n = 20), and sodium ferrigluconate complex (SFGC) (n = 20) in stage 3 and 4 CKD patients...
Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. [2007.09]
Non-dextran intravenous (i.v.) iron preparations seem to differentially affect proteinuria in patients with chronic kidney disease. To study effects of ferric gluconate and iron sucrose on proteinuria, we conducted a crossover trial in 12 patients with stage 3-4 chronic kidney disease...
Iron therapy in the pediatric hemodialysis population. [2004.06]
Iron therapy maintains iron stores and optimizes the response to recombinant human erythropoietin (r-HuEPO) in patients with end-stage renal failure. Information is limited, however, regarding the preferential route of iron administration in pediatric patients receiving hemodialysis.therapy allowed for a significant improvement in iron stores.
Single-dose pharmacokinetics of sodium ferric gluconate complex in iron-deficient subjects. [2004.05]
STUDY OBJECTIVES: To determine the single-dose pharmacokinetics of intravenous sodium ferric gluconate complex in sucrose injection (SFGC) in iron-deficient human volunteers, and to assess iron transport... CONCLUSIONS: Iron derived from SFGC appears to be rapidly transferred to a bioavailable iron compartment as transferrin-bound iron after digestion in the RES. At the doses administered in this study, liberation of potentially toxic, free iron was not detectable.
Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. [2004.04.01]
PURPOSE: Recombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients... CONCLUSION: rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added.
Clinical Trials Related to Infed (Iron Dextran)
Trial Comparing the Safety of Two Different Intravenous Iron Formulations [Recruiting]
The purpose of this trial is to compare the safety profile using equal doses of intravenous
iron dextran versus iron sucrose. The researchers hypothesize that significantly more
patients receiving intravenous iron dextran (using the current intermediate molecular weight
product) will have severe adverse outcomes than patients receiving iron sucrose in the adult
non-hemodialysis outpatient population. Secondly, since these severe reactions may require
additional nursing time and physician interventions that may negate any cost advantage of
iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than
iron dextran.
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia [Recruiting]
The objective of this study is to evaluate the safety of FCM in patients with anemia who are
not dialysis dependent.
Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer [Recruiting]
RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red
blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known
whether epoetin alfa or epoetin beta are more effective when given with or without iron
infusion in treating anemia in patients with cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare
how well they work with or without iron infusion in treating anemia in patients with cancer.
Darbepoetin Alfa With or Without IV Iron [Not yet recruiting]
2 diffierent doses of darbepoetin alfa will be administered subcutaneous (SC) on a Q3W
schedule with or without the administration of intravenous (IV) iron supplementation in the
treatment of anemia in subjects with non myeloid malignancies receiving multicycle
chemotherapy and have hemoglobin levels ≤10. 0 g/dL.
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