Exjade® (Chinese brand name: Enruige®) is the commercial brand name of Deferasirox Dispersible Tablets, an oral once-daily iron chelating agent developed by Novartis. It is an orally active tridentate iron chelator that selectively binds excess non-transferrin bound iron and labile plasma iron, promoting iron excretion via feces to relieve chronic iron overload and protect heart, liver and renal organs from iron-mediated toxic injury.
Main Indications
Treatment of chronic iron overload caused by frequent blood transfusions in patients aged 2 years and older with beta-thalassemia major and other transfusion-dependent anemias;
Treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia syndromes.
Clinical Research
Global multicenter phase III pivotal trials verified that oral deferasirox achieves durable iron burden reduction in liver and cardiac tissue with convenient once-daily oral administration, markedly improving patient medication adherence compared with traditional subcutaneous deferoxamine infusion therapy;
Registration clinical trials enrolling Chinese thalassemia patients confirmed sustained iron-lowering efficacy, predictable pharmacokinetic performance and consistent safety profiles matching global multinational trial datasets;
Long-term real-world follow-up studies in Chinese thalassemia centers demonstrated continuous control of serum ferritin levels and decreased incidence of iron-induced hepatic and cardiac complications under long-term oral chelation treatment.
Common Side Effects
Severe adverse reactions: Acute renal failure, hepatic failure, severe gastrointestinal hemorrhage, severe anaphylaxis and angioedema, cytopenias;
Common mild adverse reactions: Increased serum creatinine, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, rash, pruritus, elevated liver transaminase, headache, proteinuria.
Approval Status in China
Exjade® (Deferasirox Dispersible Tablets, 125mg per tablet, 28 tablets per box, Novartis original preparation) obtained NMPA marketing approval in June 2010 for chronic iron overload treatment after repeated blood transfusion. It is a prescription oral iron chelator for long-term outpatient management of thalassemia and transfusion-dependent anemia patients.
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