Deferasirox中文的说明书

Chinese instruction manual

[Drug Name] Deferasirox, Enrig, Deferasirox, Desirox

[Indications] Deferasirox is used for patients with iron accumulation due to long-term blood transfusion (such as thalassemia or other rare anemias). It is suitable for children over two years old and adults.

(1) Deferasirox can be used to treat reversible renal insufficiency caused by Fanconi syndrome.

(2) For the treatment of secondary hemochromatosis.

(3) Can be used to treat porphyria cutaneous tarda.

(4) For the treatment of myelodysplastic syndrome.

(5) For the treatment of iron overload caused by blood transfusion in patients with chronic anemia 2 years and older during treatment.

【Dosage】Recommended for patients with iron accumulation, such as those who require long-term blood transfusion (blood transfusion volume reaches 100 ml/kg) and whose serum ferritin exceeds 1000 μg/L;

Corresponding to body weight, it is initially recommended to take a daily dose of 20 mg/kg of Deferasirox. Depending on the improvement in serum ferritin indicators, patients may need to adjust or increase the dose of Deferasirox. Generally, the dose will be increased in units of 5 mg/kg or 10 mg/kg, but the total dose should not exceed 30 mg/kg per day.

[drug overdose]

1. Cases of overdose (taking 2-3 times the prescribed dose 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.

2. Thalassemia patients with iron overload can tolerate a single dose of 80 mg/kg with only mild nausea and diarrhea.

3. A single dose of 40mg/kg can be well tolerated by healthy volunteers.

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

[Side Effects] Common: diarrhea, vomiting, headache, abdominal pain, fever, rash, increased serum creatinine, etc.

Other side effects: increased liver enzymes, cough, throat irritation, hives.

【Notes】

1. Deferasirox may cause rash. Generally, the rash will disappear automatically without the need to adjust the dosage or stop the medication. If the condition is serious or persistent, the medication should be stopped.

2. The patient’s vision or hearing may be affected.

3. It should be taken 30 minutes before meals.

4. It should be taken at the same time every day.