Photo courtesy of the CDC
The US Food and Drug Administration (FDA) has approved a label change for Jadenu, an oral formulation of the iron chelator Exjade (deferasirox).
Jadenu comes in tablet form, and the previous label stated that Jadenu tablets must be swallowed whole.
Now, the medication can also be crushed to help simplify administration for patients who have difficulty swallowing whole tablets.
Jadenu tablets may be crushed and mixed with soft foods, such as yogurt or applesauce, immediately prior to use.
The label notes that commercial crushers with serrated surfaces should be avoided for crushing a single 90 mg tablet. The dose should be consumed immediately and not stored.
Jadenu was granted accelerated approval from the FDA earlier this year.
It is approved to treat patients 2 years of age and older who have chronic iron overload resulting from blood transfusions, as well as to treat chronic iron overload in patients 10 years of age and older who have non-transfusion-dependent thalassemia.
The full prescribing information for Jadenu can be found at http://www.pharma.us.novartis.com/product/pi/pdf/jadenu.pdf.
