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FDA Date: 2/18/10
Exjade (deferasirox) FDA Drug Safety Communication
Follow-Up to the Early Communication about an Ongoing Safety Review of Deferasirox (marketed as Exjade)
Exjade (deferasirox): Boxed Warning: Novartis Oncology and FDA notified healthcare professionals about recent changes in the prescribing information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:
- Renal impairment, including failure
- Hepatic impairment, including failure
- Gastrointestinal hemorrhage
In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high-risk myelodysplastic syndromes, underlying renal or hepatic impairment, or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI.