Desirox
Cipla, India
$40.00-
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INDICATIONS AND USAGE（适应症）
Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
Deferasirox tablet is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Deferasirox tablet is 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.
DOSAGE（服用剂量）
Transfusional Iron Overload
Deferasirox tablet therapy should only be considered when a patient has evidence of chronic transfusional iron overload. The evidence should include the transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40 kg person or more in individuals weighing more than 40 kg), and a serum ferritin consistently greater than 1,000 mcg/L.
Prior to starting therapy, or increasing dose, evaluate:
Serum ferritin level
Baseline renal function:
Obtain serum creatinine in duplicate (due to variations in measurements).
Calculate the estimated glomerular filtration rate (eGFR). Use a prediction equation appropriate for adult patients (e.g., CKD-EPI, MDRD method) and in pediatric patients (e.g., Schwartz equations).
Obtain urinalyses and serum electrolytes to evaluate renal tubular function.
Serum transaminases and bilirubin
Baseline auditory and ophthalmic examinations
ADVERSE REACTIONS（不良反应）
Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome
Hepatic Toxicity and Failure
GI Hemorrhage
Bone Marrow Suppression
Hypersensitivity
Severe Skin Reactions
Skin Rash
Auditory and Ocular Abnormalities [see Warnings and Precautions
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/31df70cb-f6a0-4cba-a02c-dc9fa6bd63bd/spl-doc?hl=Deferasirox
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