恩瑞格详细说明书

Detailed instructions

Generic name: Deferasirox

Product name: Enrig

Full names: Deferasirox, Enrig, Deferasirox, Desirox

Indications:

It is used to treat chronic iron overload in patients with β-thalassemia older than 6 years old due to frequent blood transfusions (monthly administration of concentrated red blood cells ≥7mL/kg);

For children under 6 years old and iron overload caused by other transfusion-dependent diseases, the safety and effectiveness data of Enrig in Chinese patients are limited, and it is recommended to use it with caution based on the specific conditions of the patients.

【Usage and Dosage】

It is recommended for patients with iron accumulation, such as those who require long-term blood transfusions (blood transfusions up to 100 ml/kg) and whose serum ferritin exceeds 1000 μg/L. According to the body weight, it is initially recommended to take a daily dose of 20 mg/kg of deferasirox. Depending on the improvement of serum ferritin indicators, patients may need to adjust or increase the dose of Enriga, which is usually 5 mg/kg or 10 mg/kg. The dose is adjusted in units of kilograms, but the total dose should not exceed 30 mg/kg per day.

【Adverse reactions】

Common adverse reactions: diarrhea, vomiting, headache, abdominal pain, fever, rash, increased serum creatinine, etc. Other adverse reactions: increased liver enzymes, cough, throat inflammation, urticaria. It should not be taken with aluminum-containing drugs (such as gastric acid neutralizers).

【Save】

Enrige medicines should be stored in an environment below 30°C. Do not share this medication with anyone who has the same symptoms as you. Keep away from children.

【Notes】

1. Enriga may cause a rash. Generally, the rash will disappear automatically without the need to adjust the dose 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.

[Drug interactions]

1. Avoid combination with strong inducers of UDP-glucuronosyltransferase (UGT) (such as rifampicin, phenytoin, sedatives and hypnotics, protease inhibitors) and cholestyramine.

2. It cannot be administered at the same time as aluminum-containing antacids. Not to be combined with other iron chelation treatments.

3. Be careful with repaglinide, drugs with potential ulcerogenic effects such as NSAIDs, cortisones, or oral bisphosphonates, drugs metabolized by CYP3A4 (such as cyclosporine, simvastatin, hormonal contraceptives). Pause at least 5 days before performing Gallium-67 imaging.