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Novartis Oncology and FDA notified healthcare professionals this week about recent changes in the prescribing information (PI) for Exjade, a medication indicated for the treatment of chronic iron overload due to blood transfusions in patients age 2 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; and
- gastrointestinal hemorrhage
In some reported cases, these reactions were fatal.
The adverse reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts, according to FDA.
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.
To read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter and revised PI, click here.
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