HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Exjade safely and effectively. See full prescribing information for Exjade.
EXJADE® (deferasirox) tablets for oral suspension
Initial U.S. Approval: 2005
WARNING: RENAL, HEPATIC FAILURE AND/OR GASTROINTESTINAL HEMORRHAGE

See full prescribing information for complete boxed warning

Exjade may cause:

renal impairment, including failure

hepatic impairment, including failure

gastrointestinal hemorrhage
In some reported cases, these reactions were fatal. These reactionswere more frequently observed in patients with advanced age, high risk myelodysplastic syndromes (MDS), underlying renal or hepatic impairment or low platelet counts (<50 x 109/L). Exjade therapy requires close patient monitoring, including laboratory tests ofrenal and hepatic function. (4, 5)
 
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 08/2011

Warnings and Precautions (5.2)08/2011

INDICATIONS AND USAGE
Exjade is an iron chelating agent indicated for the treatment of chronic iron overload due to blood transfusions in patients 2years of age and older. (1)

Individualize the decision to initiate Exjade therapy based on consideration of the anticipated clinical benefit and risks of the therapy, taking into consideration factors such as the life expectancy and comorbidities of the patient. (1)

The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established. (1)

DOSAGE AND ADMINISTRATION
Recommended initial daily dose is 20mg/kg body weight, taken on an empty stomach at least 30minutes before food. (2.1)

Calculate dose to the nearest whole tablet. (2.1)

Do not chew or swallow the tablets whole. (2.1)

Disperse tablets by stirring in an appropriate amount of water, orange juice, or apple juice. (2.1)

Consider increasing theinitial dose of Exjade dose to 30 mg/kg when co-administered with potent UGT inducers or withcholestyramine. (2.2)

Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. (2.2)

Reduce the starting dose by 50% in patients with moderate (Child-Pugh B) hepatic impairment. (2.2)

DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 125mg, 250mg, 500mg. (3)

CONTRAINDICATIONS
Creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. (4)

Poor performance status and high-risk MDS or advanced malignancies. (4, 5.7)

Platelet counts < 50 x 109/L. (4)

Known hypersensitivity to deferasirox or any component of Exjade. (4)

WARNINGS AND PRECAUTIONS
Exjade is not recommended in patients with severe hepatic impairment (Child-Pugh C). (5.2)

Exjade may cause hepatic failure. Monitor hepatic function during Exjade therapy. (5.2)

Fatal and non-fatal gastrointestinal bleeding, ulceration, and irritation may occur during Exjade treatment. Use caution in patients who are taking Exjade in combination with drugs that have known ulcerogenic or hemorrhagic potential, such as NSAIDs, corticosteroids, oral bisphosphonates, and anticoagulants. (5.3)

Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia have been reported. Monitor blood counts during Exjade therapy. (5.4)

Serious hypersensitivity reactions have been r