deferasirox 125 MG Tablet for Oral Suspension
1 INDICATIONS AND USAGE Deferasirox tablets for oral suspension 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 for oral suspension 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 and a serum ferritin greater than 300 mcg/L. ( 1.2 ) L imitations of Use: The safety and efficacy of deferasirox 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 for oral suspension 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 for oral suspension 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.
actavis pharma, inc.
ROUND WHITE logo 454
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEFERASIROX is provided as 125 mg, 250 mg, and 500 mg Tablets For Oral Suspension. 125 mg – white to off-white, round, unscored tablets, debossed with and 454 on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 45963-454-30) with a child-resistant closure. 250 mg – white to off-white, round, unscored tablets, debossed with and 455 on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 45963-455-30) with a child-resistant closure. 500 mg – white to off-white, round, unscored tablets, debossed with and 456 on one side and plain on the other side. Tablets are supplied in bottles of 30 (NDC 45963-456-30) with a child-resistant closure. Store at 25°C (77°F); excursions are permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 9c6b4e1d-figure-06 9c6b4e1d-figure-07 9c6b4e1d-figure-08
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