Deferasirox
Product manufactured by Actavis Pharma, Inc.
Indications and Purposes
| 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. This Indication Is Based On Achievement Of An Lic Less Than 5 Mg Fe/g Dw. An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. ( 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. This Indication Is Based On Achievement Of An Lic Less Than 5 Mg Fe/g Dw [See Clinical Studies (14)]. An Improvement In Survival Or Disease-Related Symptoms Has Not Been Established. 1.3 Limitations Of Use The Safety And Efficacy Of Deferasirox 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 |