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Desferal (Deferoxamine Mesylate) - Summary

 
 



DESFERAL SUMMARY

Desferal, deferoxamine mesylate USP, is an iron-chelating agent, available in vials for intramuscular, subcutaneous, and intravenous administration.

Desferal is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.

Desferal 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.

Desferal 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 Desferal slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis.

Iron mobilization with Desferal 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.

Desferal 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 Desferal (Deferoxamine)

High dose deferoxamine in intracerebral hemorrhage (HI-DEF) trial: rationale, design, and methods. [2013]
to move DFO forward to Phase III efficacy evaluation... CONCLUSIONS: The Hi-Def trial is expected to advance our understanding of the

The Effects of N-Acetylcysteine and Deferoxamine on Plasma Cytokine and Oxidative Damage Parameters in Critically Ill Patients With Prolonged Hypotension: A Randomized Controlled Trial. [2011.11.01]
Reactive oxygen species and inflammation have been implicated in renal tubule cell injury. However, there is some controversy concerning whether antioxidants might attenuate oxidative damage and inflammation in humans after hypotension in the setting of critical illness... NAC plus DFX administration was able to decrease plasma markers of oxidative damage and creatinine levels at hospital discharge.

Sequential alternating deferiprone and deferoxamine treatment compared to deferiprone monotherapy: main findings and clinical follow-up of a large multicenter randomized clinical trial in -thalassemia major patients. [2011]
In beta-thalassemia major (beta-TM) patients, iron chelation therapy is mandatory to reduce iron overload secondary to transfusions.These data suggest that alternating sequential L1-DFO treatment may be useful for some beta-TM patients who may not be able to receive other forms of chelation treatment.

The effects of deferoxamine mesylate on iron elimination after blood transfusion in neonatal foals. [2010.11]
BACKGROUND: Hepatic failure is one of the more common complications in foals requiring blood transfusion to treat neonatal isoerythrolysis.

Comparison of low-dose deferoxamine versus standard-dose deferoxamine for treatment of aluminium overload among haemodialysis patients. [2010.05]
BACKGROUND: Patients on maintenance haemodialysis are at high risk of aluminium overload. While deferoxamine (DFO) has potential adverse effects, lower DFO dosages may afford good efficacy with fewer side effects. We evaluated the therapeutic response of low-dose (2.5 mg/kg/week) DFO among haemodialysis patients with aluminium overload... CONCLUSIONS: Low-dose DFO may offer similar therapeutic effects as standard-dose DFO therapy.

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Clinical Trials Related to Desferal (Deferoxamine)

Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation [Terminated]
The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

Iron Balance Study of Deferasirox, Deferoxamine and the Combination of Both [Recruiting]
Subjects with thalassemia major require regular transfusion therapy to sustain life. The iron present in the transfused blood remains in the body where it can cause a variety of organ dysfunctions. Lifelong iron chelation therapy is needed to maintain iron balance but its effectiveness varies greatly. Like that of deferoxamine (Desferal, DFO) the mainstay of chelation therapy for 30 years, the effectiveness of deferasirox (Exjade, ICL670), the newly approved, orally effective iron chelating drug, is not satisfactory in all subjects. Even with good compliance, the iron excretion induced by a given drug exhibits wide subject-to-subject variability. There is often persistent iron overload of extra hepatic tissues such as the heart and pancreas leading to cardiac disease and diabetes. Combining the drugs may be a better approach in those subjects at increased risk. The iron balance studies proposed will permit an assessment of the potential of such a combination to place subjects in net negative iron balance and the relative effectiveness of the combination in relation to that of the individual drugs, an additive effect being expected. With such information, physicians will be able to design individualized chelation regimens that maximize effectiveness while minimizing side effects by adjusting the ratio and/or the dosing schedule of the two drugs.

High-Dose Deferoxamine in Intracerebral Hemorrhage [Suspended]
The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for brain hemorrhage.

Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion [Completed]
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.

Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload [Completed]
This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart. Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.

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Reports of Suspected Desferal (Deferoxamine) Side Effects

Pyrexia (9)Vomiting (8)Sepsis (8)Serum Ferritin Increased (7)Dyspnoea (7)Nausea (7)Diarrhoea (7)Asthenia (7)Infection (6)Oedema Peripheral (5)more >>


Page last updated: 2014-11-30

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