Rx Item-Exjade 250Mg Tab 30 By Novartis Healthcare

EXJADE- deferasirox tablet, for suspension
Novartis Pharmaceuticals Corporation

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

Exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
Measure serum creatinine and determine creatinine clearance in duplicate prior to initiation of therapy and monitor renal function at least monthly thereafter. For patients with baseline renal impairment or increased risk of acute renal failure, monitor creatinine weekly for the first month, then at least monthly. Consider dose reduction, interruption, or discontinuation based on increases in serum creatinine [see Dosage and Administration (2.4, 2.5), Warnings and Precautions (5.1)].


Hepatic Failure

Exjade can cause hepatic injury including hepatic failure and death.
Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
Avoid use of Exjade in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].
Gastrointestinal Hemorrhage

Exjade can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
Monitor patients and discontinue Exjade for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE

1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. This indication is based on a reduction of liver iron concentrations and serum ferritin levels [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established [see Indications and Usage (1.3)].

1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. This indication is based on achievement of an LIC less than 5 mg Fe/g dw [see Clinical Studies (14)]. An improvement in survival or disease-related symptoms has not been established.

RX ITEM-Exjade 250Mg Tab 30 By Novartis
NDC 00078-0469-15 UPC/GTIN No.3-00780-46915-9 Mfg.Part No.27364 Exjade 250mg Tab 30 by Novartis Healthcare

Exjade 250Mg Tab 30 By Novartis Healthca
BRAND: EXJADE NDC: 00078-0469-15,78046915 UPC: 3-00780-46915-9,300780469159 Specialty Healthcare Exjade 250mg Tab 30 by Novartis Healthcare

DEFERASIROX ORAL TAB DISP
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Exjade 250mg Tab 30 by Novartis Healthcare