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FDA Approves Jadenu (deferasirox ) to Simplify Treatment Administration for Patients with Chronic Iron Overload

Posted 30 Mar 2015 by Drugs.com

Basel, March 30, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole. Many patients with sickle cell disease, thalassemia or myelodysplastic syndromes need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu oral tablets can be taken in a single step, with or without a light meal, simplifying administration of treatment for chronic iron overload. Exjade is a dispersible tablet that must be mixed in liquid ... Read more

Related support groups: Exjade, Deferasirox, Iron Overload

FDA Approves Exjade to Remove Excess Iron in Patients with Genetic Blood Disorder

Posted 23 Jan 2013 by Drugs.com

January 23, 2013 – The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs. The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade. The agency previously cleared FerriScan for measuring liver iron concentration (LIC), but its use in Exjade clinical studies to select patients for therapy, and to manage therapy, defined its role as an imaging companion diagnostic necessary for Exjade’s safe and effective use. F ... Read more

Related support groups: Thalassemia, Exjade, Deferasirox, Iron Overload Disease

Exjade Approved for Inherited Blood Disorder

Posted 23 Jan 2013 by Drugs.com

WEDNESDAY, Jan. 23 – Exjade (deferasirox) has been approved by the U.S. Food and Drug Administration to remove excess iron in the blood among people with a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). Too much iron in the blood can damage vital organs, the agency said Wednesday in a news release. Thalassemia typically leads to the production of fewer red blood cells and less hemoglobin, a protein that carries oxygen throughout the body. NTDT is a milder form of thalassemia that unlike other forms, does not require frequent blood transfusions. Thalassemia affects about 1,000 people in the United States, the FDA said. The FDA previously approved Exjade to treat chronic iron overload among people who require blood transfusions. The drug is produced by Novartis, East Hanover, N.J. More information The U.S. National Heart Lung and Blood Institute has more ... Read more

Related support groups: Thalassemia, Exjade, Deferasirox

FDA Medwatch Alert: Exjade (deferasirox)

Posted 13 Dec 2007 by Drugs.com

[UPDATE 12/13/2007] Novartis informed healthcare professionals of changes made to the WARNINGS, ADVERSE REACTIONS, and DOSAGE and ADMINISTRATION sections of prescribing information for Exjade Tablets for Oral Suspension. The WARNINGS and ADVERSE REACTIONS sections of the labeling were revised to include information about postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure.[Posted 05/22/2007] Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in ... Read more

Related support groups: Exjade

FDA Medwatch Alert: Exjade (deferasorix) Tablets For Oral Suspension

Posted 22 May 2007 by Drugs.com

[Posted 05/22/2007] Novartis and FDA notified healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the product labeling for Exjade, a drug used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. Cases of acute renal failure, some with a fatal outcome, have been reported following the post marketing use of Exjade. Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders. Additionally, there were post marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with Exjade where some of the patients died. The relationship of these episodes to treatment with Exjade is uncertain. Most of these patients had preexisting hematologic disorders that are ... Read more

Related support groups: Exjade

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Related Condition Support Groups

Iron Overload, Thalassemia, Hemosiderosis

Exjade Patient Information at Drugs.com