Caution patients about potential loss of effectiveness of drugs metabolized by CYP3A4 (e.g., cyclosporine, simvastatin, hormonal contraceptive agents) when Exjade is administered with these drugs.

Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with potent UGT inducers.

Perform careful monitoring of glucose levels when repaglinide is used concomitantly with Exjade.An interaction between Exjade and other CYP2C8 substrates like paclitaxel cannot be excluded.

Advise patients that blood tests will be performed because EXJADE may affect your kidneys, liver, or blood. The blood tests will be performed every month or more frequently if you are at increased risk of complications (e.g., pre-existing kidney condition, are elderly, have multiple medical conditions, or are taking medicine that affects your organs). There have been reports of severe kidney and liver problems, blood disorders, stomach bleeds and death in patients taking Exjade.

Skin rashes may occur during Exjade treatment and if severe treatment should be interrupted. Serious allergic reactions (which include swelling of the throat) have been reported in patients taking EXJADE, usually within the first month of treatment. If reactions are severe, advise patients to stop taking EXJADE and contact their doctor immediately.

Certain patients should not receive Exjade. These include patients with severe (Child-Pugh C) hepatic impairment, creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal, patients with poor performance status and high-risk myelodysplastic syndromes or advanced malignancies, patients with platelet counts <50 x 109/L, and those with hypersensitivity to deferasirox or any component of Exjade.

Manufactured by:

Novartis Pharma Stein AG

Stein, Switzerland

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

© Novartis

T2011-106

PRINCIPAL DISPLAY PANEL

Package Label – 125 mg Tablets for Oral Suspension

Rx OnlyNDA 0078-0468-15

EXJADE® (deferasirox)

Tablets for Oral Suspension

125 mg per tablet

30 Tablets

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

PRINCIPAL DISPLAY PANEL

Package Label – 250 mg Tablets for Oral Suspension

Rx OnlyNDA 0078-0469-15

EXJADE® (deferasirox)

Tablets for Oral Suspension

250 mg per tablet

30 Tablets

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

PRINCIPAL DISPLAY PANEL

Package Label – 500 mg Tablets for Oral Suspension

Rx OnlyNDA 0078-0470-15

EXJADE® (deferasirox)

Tablets for Oral Suspension

500 mg per tablet

30 Tablets

DO NOT CHEW OR SWALLOW WHOLE

*Tablets MUST be dispersed in water,

orange or apple juice prior to ingestion.

EXJADE
deferasirox tablet, for suspension
Pro