deferasirox 90 MG Oral Tablet
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.
Zydus Pharmaceuticals (USA) Inc.
OVAL WHITE 1275
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deferasirox 360 MG Oral Tablet
Zydus Pharmaceuticals (USA) Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEFERASIROX tablets, 90 mg are white to off-white-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1275" on one side and plain on other side and are supplied as follows: NDC 70710-1275-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1275-1 in bottles of 100 tablets.
DEFERASIROX tablets, 180 mg are light blue-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1276" on one side and plain on other side and are supplied as follows: NDC 70710-1276-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1276-1 in bottles of 100 tablets.
DEFERASIROX tablets, 360 mg are blue-colored, oval-shaped, biconvex, film-coated tablets, debossed with "1277" on one side and plain on other side and are supplied as follows: NDC 70710-1277-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1277-1 in bottles of 100 tablets. Storage Store
DEFERASIROX tablets at 25°C (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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