deferasirox 360 mg
1 INDICATIONS AND USAGE Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox tablets are 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 (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2) Limitations of Use: The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload) Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes Deferasirox tablets are 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. 1.3 Limitations of Use The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established.
Sun Pharmaceutical Industries, Inc.
OVAL BLUE S104
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEFERASIROX tablets 90 mg are light blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S102’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-768-83).
DEFERASIROX tablets 180 mg are medium blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S103’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-769-83).
DEFERASIROX tablets 360 mg are dark blue oval biconvex film-coated tablets with beveled edges, debossed with ‘S104’ on one side and plain on the other side. They are available in bottles of 30 tablets (NDC 57664-770-83). Store
DEFERASIROX tablets at 20°C-25°C (68°F-77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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