JADENU may cause renal toxicity including failure, hepatic toxicity including failure, and GI hemorrhage. JADENU therapy requires close patient monitoring, including renal/hepatic laboratory tests.
INDICATION
Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
JADENU® (deferasirox) tablets and JADENU® Sprinkle (deferasirox) granules are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Limitations of Use
IMPORTANT SAFETY INFORMATION for JADENU® (deferasirox) Tablets and JADENU® Sprinkle (deferasirox) granules
WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE
Renal Failure
Hepatic Failure
Gastrointestinal Hemorrhage
CONTRAINDICATIONS
JADENU is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Renal Toxicity, Renal Failure, and Proteinuria
Hepatic Toxicity and Failure
Gastrointestinal (GI) Ulceration, Hemorrhage, and Perforation
Bone Marrow Suppression
Increased Risk of Toxicity in the Elderly
Hypersensitivity
Severe Skin Reactions
Skin Rash
Auditory and Ocular Abnormalities
Overchelation
ADVERSE REACTIONS
Please see full Prescribing Information for JADENU® (deferasirox) tablets and JADENU® Sprinkle (deferasirox) granules, including Boxed WARNING.