Deferasirox 500 mg Film-Coated Tablets

Oral Iron Chelator – Hematologic Support Agent / Chelating Agent

ATC Code: V03AC03

WHO Essential Medicines List: ✔️ Yes

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Product Description

Deferasirox is an oral tridentate iron chelating agent used to reduce chronic iron overload in patients receiving long-term blood transfusions (transfusional hemosiderosis) and in patients with non-transfusion-dependent thalassemia (NTDT) syndromes. It binds selectively to ferric iron (Fe³⁺), forming a stable complex that is eliminated primarily via feces.

Deferasirox offers a convenient once-daily oral alternative to parenteral iron chelators and is recognized globally for improving iron-related outcomes in thalassemia and myelodysplastic syndromes (MDS). The molecule is included on the WHO Model List of Essential Medicines.

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Available Presentation

• Strength per tablet: 500 mg
• Formulation: Film-coated oral tablet
• Volume: Solid oral dose form
• Packaging: Box of 28 tablets (4-week cycle)
• Dilution Required: ❌ No
• Storage Conditions: Store below 30°C; protect from moisture

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Indications

• Treatment of chronic iron overload due to repeated blood transfusions in patients aged ≥2 years
• Treatment of chronic iron overload in patients with NTDT syndromes when associated with increased liver iron concentration (LIC ≥5 mg Fe/g dry weight) and serum ferritin >300 mcg/L

Uses

• Primary Use: Hematologic – Iron chelation therapy
• Disease Areas: β-thalassemia major, Sickle cell anemia, Myelodysplastic syndromes (MDS), Aplastic anemia
• Organ Protection: Reduces cardiac and hepatic iron overload

Off-Label / Investigational Uses

• Iron overload in rare anemias not officially approved by regulatory authorities
• Combination therapy to reduce chelator resistance (investigational)

Pediatric Use

Approved for use in children ≥2 years with iron overload due to transfusions. Dosage should be weight-based and adjusted based on serum ferritin and iron studies.

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Regulatory and Safety Profile

• ATC Code: V03AC03
• WHO Essential Medicines List: ✔️ Yes
• Pharmacologic Class: Iron Chelating Agent
• Black Box Warning (U.S. FDA): ✔️ Yes
  • Renal failure, including fatalities
  • Hepatic failure, including fatalities
  • Gastrointestinal hemorrhage, especially in elderly patients
• Regulatory Status: Registered in multiple countries; available as originator and generic

Contraindications

• Hypersensitivity to Deferasirox or excipients
• Severe renal impairment (CrCl <40 mL/min)
• High-risk MDS patients not receiving transfusions
• Platelet count <50,000/mm³

Common Side Effects

• Nausea, vomiting, abdominal pain, diarrhea
• Serum creatinine elevation, proteinuria
• Liver enzyme elevation
• Skin rash
• Rare: auditory or visual disturbances

Monitoring Parameters

• Serum ferritin every 3 months
• Renal function (serum creatinine, BUN) weekly during initiation, then monthly
• Liver function tests monthly
• Urinalysis for proteinuria monthly
• Annual audiometry and ophthalmology evaluation