Deferasirox
Product manufactured by Zydus Pharmaceuticals (Usa) Inc.
Indications and Purposes
| 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. This Indication Is Approved Under Accelerated Approval Based On A Reduction Of Liver Iron Concentrations (To Less Than 5 Mg Fe/g Dw) And Serum Ferritin Levels. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 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. This Indication Is Approved Under Accelerated Approval Based On A Reduction Of Liver Iron Concentrations (To Less Than 5 Mg Fe/g Dw) And Serum Ferritin Levels [See Clinical Studies ( 14 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. 1.3 Limitations Of Use The Safety And Efficacy Of Deferasirox Tablets When Administered With Other Iron Chelation Therapy Have Not Been Established. |
All Formulated Excipients (0 Total)
None
Active Ingredients ( 1 Total)
| Name | Structure | ZINC ID(s) |
|---|---|---|
| 1. Deferasirox |
|
ZINC1481815 |