Novartis has informed HealthCare Provider about the December 2006 changes made to the WARNINGS and ADVERSE REACTIONS sections of the Exjade ( Deferasirox ) tablets for oral suspension prescribing information.

Exjade is indicated for the treatment of chronic iron overload due to blood transfusions ( transfusional hemosiderosis )in patients 2 years of age and older.

In the U.S. package insert for Exjade, the following information has been added to the WARNINGS section.

Renal

Cases of acute renal failure,some with a fatal outcome, have been reported following the postmarketing use of Exjade.
Most of the fatalities occurred in patients with multiple co-morbidities and who were in advanced stages of their hematological disorders.
Particular attention should be given to monitoring serum creatinine in patients who:are at increased risk of complications,have preexisting renal conditions,are elderly, have co-morbid conditions,or are receiving medicinal products that depress renal function.
Serum creatinine should be assessed in duplicate before initiating therapy to establish a reliable pre-treatment baseline,due to variations in measurements. Serum creatinine should be monitored monthly thereafter.
Patients with additional renal risk factors should be monitored weekly during the first month after initiation or modification of therapy,and monitored monthly thereafter.

Cytopenias ( formerly Pancytopenia )

There have been postmarketing reports ( both spontaneous and from clinical trials )of cytopenias, including agranulocytosis,neutropenia and thrombocytopenia, in patients treated with Exjade. Some of these patients died.
The relationship of these episodes to treatment with Exjade is uncertain.
Most of these patients had preexisting hematologic disorders that are frequently associated with bone marrow failure.
In line with the standard clinical management of such hematological disorders, blood counts should be monitored regularly.
Interruption of treatment with Exjade should be considered in patients who develop unexplained cytopenia.
Reintroduction of therapy with Exjade may be considered,once the cause of the cytopenia has been elucidated.

Source: FDA, 2007

XagenaMedicine2007


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