Rx Item-Jadenu deferasirox ORAL 360Mg Tab 30 By Novartis

For: Iron Overload

Jadenu (deferasirox) is a tablet formulation of Exjade, an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

JADENU- deferasirox tablet, film coated
JADENU- deferasirox granule
Novartis Pharmaceuticals Corporation

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

JADENU 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 (CLcr) 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

JADENU 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 JADENU 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

JADENU 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 JADENU 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)
JADENU 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 approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
JADENU 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 approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg Fe/g dw) and serum ferritin levels [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

RX ITEM-Jadenu 360Mg Tab 30 By Novartis
NDC 00078-0656-15 UPC/GTIN No.3-00780-65615-3 Mfg.Part No.65615

Jadenu 360Mg Tab 30 By Novartis
BRAND: JADENU NDC: 00078-0656-15,78065615 UPC: 3-00780-65615-3,300780656153 Novartis Pharma Corp

DEFERASIROX ORAL TABLET 3
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