去铁药地拉罗司片说明书

Common name: (Enrig)

Product name: Enrig

English name: Deferasirox Dispersible Tablets

Chinese Pinyin: Dilaluosi Fensanpian

【Ingredients】

The active ingredient of this product is deferasirox.

Chemical name: 4-[3,5-bis(2-hydroxyphenyl)-1H-[1,2,4]-triazol-1-yl]benzoic acid

Molecular formula: C21H15N3O4

Molecular weight: 373.4

[Character] 125mg: white to slightly yellow tablets, approximately 12 mm in diameter;

[Indications] It is used to treat chronic iron overload in beta-thalassemia patients older than 2 years old due to frequent blood transfusions (monthly administration of concentrated red blood cells ≥7ml/kg). For iron overload caused by other transfusion-dependent diseases, the safety and effectiveness data of this product in Chinese patients are limited, and it is recommended to take it as directed by the doctor.

【Specification】125mg

【Usage and Dosage】

Initial and maintenance treatment should be implemented by physicians experienced in treating chronic iron overload caused by blood transfusions. Individualized iron-depleting treatment decisions should be made based on the expected clinical benefits and risks of treatment with this product, while taking into account the patient's life expectancy and comorbidities. In patients requiring iron chelation therapy, it is recommended to initiate therapy with proven iron overload, for example after a transfusion of approximately 100 mL/kg of packed red blood cells (approximately 20 International Units for a patient weighing 40 kg) or when serum ferritin persists >1000ug/L.

The goals of iron chelation therapy are to remove iron introduced by transfusion and, if necessary, to reduce the existing iron load.

Starting dose

The recommended starting daily dose of this product is 20mg/kg

For patients who receive monthly transfusions of more than 14 mL/kg of packed red blood cells (i.e., approximately more than 4 international units/month in adults) and who need to reduce iron overload, a starting dose of 30 mg/kg/day may be considered.

For patients who receive monthly transfusions of less than 7 mL/kg of packed red blood cells (ie, approximately less than 2 international units/month for adults) and who need to maintain iron balance in the body, a starting dose of 10 mg/kg/day may be considered.

【Taboo】

1. People who are known to be allergic to the active ingredients or any excipients

2. It should not be used in combination with other iron chelation treatments because the safety of such combined use has not been established.

3. It is prohibited to be used in patients with creatinine clearance <40mL/min or serum creatinine >2 times the upper limit of normal for the corresponding age.

4. Patients with poor general condition, high-risk myelodysplastic syndrome (MDS) or advanced malignant tumors

5. Patients with myelodysplastic syndrome (MDS) whose platelet count is <50×109/L.

[Geriatric Use] Clinical studies of deferasirox included 431 patients aged ≥65 years. Most of the above patients had myelodysplastic syndrome (MDS) (n=393). In these studies, elderly patients experienced adverse reactions more frequently than younger patients. Elderly patients should be closely monitored for early symptoms or signs of adverse reactions that may require dose adjustment. Elderly patients are at increased risk for deferasirox toxicity due to reduced hepatic, renal, and cardiac function and a greater frequency of comorbidities or other medications.

[Drug Overdose] Cases of drug overdose (taking 2-3 times the prescribed amount for several weeks) have been reported. One case report reported that an overdose resulted in subclinical hepatitis, which resolved after discontinuation of the drug, with no long-term effects. Thalassemia patients with iron overload can tolerate a single dose of 80 mg/kg with only mild nausea and diarrhea. A single dose of 40 mg/kg was well tolerated by healthy volunteers.

Signs of acute overdose include nausea, vomiting, headache, and diarrhea. Treatment of overdose includes induction of vomiting, gastric lavage, and symptomatic treatment.

[Storage] Moisture-proof, sealed and stored below 30°C (Enrige), out of reach of children.

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