Last reviewed 2026-04-20 · How we verify

Exjade (DEFERASIROX)

Exjade works by binding to iron in the body and removing it through the urine.

Deferasirox (Exjade), marketed by Novartis, is a leading treatment for chronic iron overload, with a key composition patent expiring in 2028. Its primary strength lies in its mechanism of action, effectively binding and removing excess iron through urine, offering a convenient oral alternative to injectable deferoxamine. The primary risk is competition from off-patent deferoxamine, which has five generics available, and deferiprone, a patent-protected competitor with a patent expiry in 2029.

At a glance

Mechanism of action

Deferasirox is an orally active chelator that is selective for iron (as Fe3+). It is tridentate ligand that binds iron with high affinity in 2:1 ratio. Although deferasirox has very low affinity for zinc and copper, there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

Approved indications

• Chronic Iron Overload
• beta Thalassemia

Boxed warnings

• WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1 , 2.4 , 2.5 ), Warnings and Precautions (5.1) , Adverse Reactions (6.1 , 6.2 )]. Hepatic Failure Deferasirox can cause hepatic injury including hepatic failure and death. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.2 )]. Gastrointestinal Hemorrhage Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts. Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage [see Warnings and Precautions ( 5.3 )]. WARNING: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE See full prescribing information for complete boxed warning. Deferasirox may cause serious and fatal: acute kidney injury, including acute renal failure requiring dialysis and renal tubular toxicity including Fanconi syndrome (5.1) hepatic toxicity, including failure (5.2) gastrointestinal hemorrhage (5.3) Deferasirox therapy requires close patient monitoring, including laboratory tests of renal and hepatic function. (5)

Common side effects

• Increases in serum creatinine
• Diarrhea
• Abdominal pain
• Nausea
• Vomiting
• Rash
• Creatinine Increased
• SGPT/ALT levels greater than 5 times the ULN

Drug interactions

• cholestyramine
• colesevelam
• colestipol
• fosphenytoin
• phenobarbital
• phenytoin
• primidone
• rifampicin
• ritonavir
• theophylline
• tizanidine

Key clinical trials

• Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.
• Combination of Thalidomide and Hydroxyuria in Transfusion Dependent Thalasemmia (PHASE2)
• Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation (PHASE2)
• Early Screening and Treatment of Heart Complication in Sickle Cell Disease (PHASE2)
• Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia (PHASE3)
• Risk Factors and Measures to Prevent Liver and Pancreas Complications in Pediatric Patients After HSCT
• Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical Study (NA)
• Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Exjade CI brief — competitive landscape report
• Exjade updates RSS · CI watch RSS
• Novartis portfolio CI