DEFEROXAMINE SUMMARY
Vitamin C:
Deferoxamine mesylate for injection, USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration.
Deferoxamine mesylate for injection is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.
Acute Iron Intoxication
Deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis.
Chronic Iron Overload
Deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). Long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis.
Iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. The drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated.
Deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.
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NEWS HIGHLIGHTS
Published Studies Related to Deferoxamine
Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial. [2009.04]
A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8-12 h) at 50 mg/kg per day for the remaining 3 d/week was compared with DFP alone at 75 mg/kg, administered 7 d/week during a 5-year follow-up...
Inflammation and oxidant-stress in beta-thalassemia patients treated with iron chelators deferasirox (ICL670) or deferoxamine: an ancillary study of the Novartis CICL670A0107 trial. [2008.06]
BACKGROUND: We assessed whether oxidant-stress and inflammation in beta-thalassemia could be controlled by the novel oral iron chelator deferasirox as effectively as by deferoxamine... CONCLUSIONS: Iron chelation therapy with deferoxamine or with deferasirox was equally effective in decreasing iron burden and malondialdehyde. The possible differential effect of the two chelators on inflammation warrants further investigation.
Patient-reported outcomes of deferasirox (Exjade, ICL670) versus deferoxamine in sickle cell disease patients with transfusional hemosiderosis. Substudy of a randomized open-label phase II trial. [2008]
BACKGROUND/AIMS: There is increasing evidence demonstrating the value of transfusions in sickle cell disease (SCD). However, resultant iron overload can be life threatening if untreated. Chelation therapy with deferoxamine requires parenteral infusions that can negatively impact quality of life and adherence to treatment... CONCLUSIONS: Patients with SCD are therefore more satisfied with deferasirox, which has a lower impact on daily activities than deferoxamine. Given the high levels of satisfaction, it is likely that quality of life will be improved. These results also suggest that treatment adherence with deferasirox may be better than with deferoxamine, which should lead to improved long-term outcomes. 2008 S. Karger AG, Basel.
Prospective evaluation of patient-reported outcomes during treatment with deferasirox or deferoxamine for iron overload in patients with beta-thalassemia. [2007.05]
BACKGROUND: Iron chelation therapy (ICT) with deferoxamine (DFO), the current standard for the treatment of iron overload in patients with transfusion-dependent disorders such as beta-thalassemia, requires regular subcutaneous or intravenous infusions. This can lead to reduced quality of life and poor adherence, resulting in increased morbidity and mortality in iron-overloaded patients with beta-thalassemia. Deferasirox is an orally administered iron chelator that has been approved for use in the United States, Switzerland, and other countries. OBJECTIVE: This analysis was conducted to compare patient-reported outcomes (PROs) during receipt of DFO infusions or once-daily oral therapy with deferasirox (ICL670)... CONCLUSIONS: In this study, patient-reported satisfaction and convenience were significantly higher for the once-daily, oral ICT deferasirox than for DFO infusions. Among patients who had received DFO before the study, the majority indicated a preference for deferasirox over DFO. Most patients receiving deferasirox indicated that they would be willing to continue taking it. These results suggest that deferasirox had a positive impact on patients' daily lives.
A randomized, placebo-controlled, double-blind trial of the effect of combined therapy with deferoxamine and deferiprone on myocardial iron in thalassemia major using cardiovascular magnetic resonance. [2007.04.10]
CONCLUSIONS: In comparison to the standard chelation monotherapy of deferoxamine, combination treatment with additional deferiprone reduced myocardial iron and improved the ejection fraction and endothelial function in thalassemia major patients with mild to moderate cardiac iron loading.
Clinical Trials Related to Deferoxamine
Safety & Efficacy of ICL670 Vs. Deferoxamine in Beta-Thalassemia Patients With Iron Overload Due to Blood Transfusions [Completed]
The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is
as effective and as safe as deferoxamine in preventing accumulation of iron in the body while
a patient is undergoing repeated blood transfusions.
Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions [Completed]
The purpose of this study is to determine if the new orally active iron chelator, ICL670, is
as safe as deferoxamine in preventing accumulation of iron in the body while a patient is
undergoing repeated blood transfusions.
Efficacy Study in Removing Excess Iron From the Heart [Completed]
The purpose of this study is to determine whether deferiprone has superior efficacy in
removing excess iron from the heart when compared with deferoxamine.
Deferoxamine for the Treatment of Hemochromatosis [Active, not recruiting]
When patients receive repeated blood transfusions the level of iron in the patient's blood
can rise. When iron is processed in the body a protein known as hemosiderin can begin
collecting in the organs. If too much hemosiderin collects in the organs they can begin to
malfunction. This condition is called transfusional hemochromatosis.
An organ of particular importance in transfusional hemochromatosis is the heart. Patients
born with diseases requiring blood transfusions at birth begin to develop heart problems in
their teens. These patients typically only live for 17 years. Adults that require
transfusions can begin experiencing heart problems after 100-200 units of backed red blood
cells.
Deferoxamine (Desferal) is a drug that binds to iron and allows it to be excreted from the
body. It is the only effective way to remove iron from patients who have been overloaded
with iron because of multiple transfusions. Previous studies have lead researchers to
believe that deferoxamine, when given as an injection under the skin (subcutaneous), can be
delay or prevent heart complications.
Researchers plan to continue studying patients receiving deferoxamine as treatment for the
prevention of heart complications associated with repeated blood transfusions. In this study
researchers will attempt;
1. To determine if deferoxamine, given regularly, can indefinitely prevent the heart,
liver, and endocrine complications associated with transfusional hemochromatosis
2. To determine whether heart disease caused by transfusional hemochromatosis can be
reversed by intensive treatment with deferoxamine.
Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion [Recruiting]
Iron overload has been associated with greater brain injury in ischemia/reperfusion
experimental stroke models and ischemic stroke patients, especially in those treated with
thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a
neuroprotective action in ischemia/reperfusion animal models.
Primary objective: To evaluate the security and tolerability of deferoxamine endovenous
treatment in acute ischemic stroke patients treated with iv. tPA.
Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus
(10 mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To
evaluate the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic
transformation and brain edema development.
Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical
trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15: 5); 2nd: bolus+40 mg/Kg/day
vs. Placebo (n=15: 5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15: 5). These doses will be
increased according to security results of the previous stage. Patients will be continuously
monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and
30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine
concentrations will be measured along time after the injection in a subgroup of patients to
the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic
transformation and brain edema. The NIH Stroke Scale will be evaluated during
hospitalization, and the Rankin score at discharge and 3 months.
If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke
patients, it may be a new therapy option to lower the brain injury after ischemia and
reperfusion.
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