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Ferriprox (Deferiprone) - Summary

 
 



WARNING: AGRANULOCYTOSIS/NEUTROPENIA

  • Ferriprox can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions]

  • Measure the absolute neutrophil count (ANC) before starting Ferriprox therapy and monitor the ANC weekly on therapy. Interrupt Ferriprox therapy if neutropenia develops. [see Warnings and Precautions ]

  • Interrupt Ferriprox if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions ]

  • Advise patients taking Ferriprox to report immediately any symptoms indicative of infection. [see Warnings and Precautions]

 

FERRIPROX SUMMARY

Ferriprox (deferiprone) tablets contain 500 mg deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a synthetic, orally active, iron-chelating agent.

FERRIPROX® (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Approval is based on a reduction in serum ferritin levels. There are no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms, functioning, or increased survival [see Clinical Studies].

Limitation of Use:

  • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with other chronic anemias.

See all Ferriprox indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ferriprox (Deferiprone)

Deferiprone (L1) as an adjuvant therapy for Plasmodium falciparum malaria. [2002]
course and final outcome... CONCLUSION: Deferiprone (L1) seems to be a promising agent

Assessment of the effect of the oral iron chelator deferiprone on asymptomatic Plasmodium falciparum parasitemia in humans. [1998]
While the parenteral iron-chelating agent desferrioxamine B has anti-malarial activity in humans, the usefulness of an orally active chelator for this indication has not been investigated previously in vivo. We conducted a prospective, double-blind, placebo-controlled, cross-over trial of deferiprone (L1; CP20; 1,2-dimethyl-3-hydroxypyridin-4-one) in 25 adult Zambians with asymptomatic Plasmodium falciparum parasitemia...

Oral deferiprone for iron chelation in people with thalassaemia. [2013]
CONCLUSIONS: In the absence of data from randomised controlled trials,

Long-term treatment with deferiprone enhances left ventricular ejection function when compared to deferoxamine in patients with thalassemia major. [2013]
Transfusion and iron chelation treatment have significantly reduced morbidity and improved survival of patients with thalassemia major. However, cardiac disease continues to be the most common cause of death... However, because of limitations related to the design of this study, these findings should be confirmed in a prospective, randomized clinical trial.

The effect of combined therapy with deferoxamine and deferiprone on serum ferritin level of beta-thalassemic patients. [2012]
CONCLUSION: Combined therapy with deferoxamine and deferiprone significantly

more studies >>

Clinical Trials Related to Ferriprox (Deferiprone)

Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox� in Patients With Sickle Cell Disease [Completed]
The objective of this study is to evaluate the pharmacokinetics of deferiprone and its 3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in patients with sickle cell disease.

Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers [Active, not recruiting]
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.

A Two-arm Efficacy and Safety Study of Deferiprone in Patients With Pantothenate Kinase-associated Neurodegeneration (PKAN) [Active, not recruiting]
A multi-center, placebo controlled, double-blind trial comparing the efficacy and safety of 18 months of treatment with deferiprone versus placebo in patients with PKAN. This investigator-initiated trial is funded by the European Commission's Seventh Framework Programme (FP7/2007-2013, HEALTH-F2-2011, grant agreement No. 277984) to the TIRCON consortium (Treat Iron-Related Childhood-Onset Neurodegeneration) and by the FDA OOPD (Dr. Elliott Vichinsky)

A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers [Completed]
Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.

more trials >>


Page last updated: 2014-11-30

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