deferasirox 360 MG Oral Tablet
1 INDICATIONS AND USAGE Deferasirox is 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 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 (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.
Amneal Pharmaceuticals NY LLC
OVAL BLUE AC36
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Amneal Pharmaceuticals NY LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
DEFERASIROX tablets, 90 mg are supplied as light blue colored, oval shaped, film-coated tablets debossed with “AC34” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 69238-1486-3
DEFERASIROX tablets, 180 mg are supplied as blue colored, oval shaped, film-coated tablets debossed with “AC35”on one side and plain on other side. They are available as follows: Bottles of 30: NDC 69238-1487-3
DEFERASIROX tablets, 360 mg are supplied as dark blue to blue colored, oval shaped, film-coated tablets debossed with “AC36”on one side and plain on other side. They are available as follows: Bottles of 30: NDC 69238-1488-3 Store
DEFERASIROX tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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