deferasirox tablet film coated
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 when administered with other iron chelation therapy have not been established.
teva pharmaceuticals usa, inc.
OVAL BLUE TV D21
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deferasirox tablet film coated
teva pharmaceuticals usa, inc.
deferasirox tablet film coated
teva pharmaceuticals usa, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Deferasirox 90 mg tablets are light blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D22” on the other side. Tablets are available in bottles of 30 (NDC 0093-3517-56). Deferasirox 180 mg tablets are medium blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D17” on the other side. Tablets are available in bottles of 30 (NDC 0093-3516-56). Deferasirox 360 mg tablets are dark blue, film-coated, modified oval shape tablets, debossed with “TV” on one side and “D21” on the other side. Tablets are available in bottles of 30 (NDC 0093-3515-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
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