Wendiping Deferasirox Granules

1. Indications and Usage
Deferasirox granules are indicated for chronic iron overload due to blood transfusions in patients 2 years and older with transfusion-dependent anemias, and for chronic iron overload in patients 10 years and older with non-transfusion-dependent thalassemia syndromes.
2. Dosage and Administration
Transfusion-Dependent Anemias: The recommended starting dose is 20 mg/kg of body weight once daily. Dose adjustments should be made in 5 mg/kg increments based on serum ferritin levels and tolerability.
Non-Transfusion-Dependent Thalassemia: The recommended starting dose is 10 mg/kg of body weight once daily.
Administration: The granules must be dispersed in a small amount of water, apple juice, or orange juice (approximately 100-200 mL) and taken immediately. The suspension must not be swallowed whole. It should be taken once daily at approximately the same time, at least 30 minutes before food.
3. Mechanism of Action
Deferasirox is a high-affinity trivalent iron chelator. It binds to free iron in the body to form a stable, water-soluble complex that is subsequently excreted primarily in the feces and to a lesser extent in the urine, thereby reducing total body iron stores.
4. Safety and Warnings
Renal and Hepatic Toxicity: Deferasirox can cause renal, hepatic, and bone marrow toxicity. Renal function must be monitored monthly, and liver function tests should be monitored regularly, especially during the first year of treatment.
Gastrointestinal Hemorrhage: There is an increased risk of gastrointestinal hemorrhage, particularly in patients with mucosal lesions or coagulopathy.
Death and Serious Adverse Events: Serious adverse events, including death, have been reported, most commonly in patients with Myelodysplastic Syndromes (MDS) or high-risk MDS.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequently reported adverse reactions include diarrhea, nausea, vomiting, abdominal pain, skin rash, and elevated serum creatinine.
Clinical Research: Clinical trials have demonstrated that deferasirox effectively reduces iron overload, as evidenced by decreased serum ferritin levels and liver iron concentration.
6. Drug Interactions
Antacids: Concomitant use with aluminum-containing antacids is not recommended due to potential interactions.
CYP2C8 Inhibitors: Drugs that inhibit CYP2C8 may increase the exposure to deferasirox.
UGT Inducers: Concomitant use with UDP-glucuronosyltransferase (UGT) inducers (e.g., rifampin) may decrease deferasirox exposure.
7. Pharmaceutical Information
Composition: The active ingredient is deferasirox. Common granule strengths include 125 mg/sachet and 500 mg/sachet.
Appearance: The granules are typically yellow to pale yellow.
Storage: Store in a dry place at controlled room temperature, protecting from moisture.