地拉罗司 使用说明

It is an iron chelator indicated for the treatment of chronic iron overload caused by transfusion in patients 2 years of age and older. This indication was approved under accelerated approval based on reductions in hepatic iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials. Today we will take a look at the instructions for use of deferasirox.

Generic name: Deferasirox

Product name: Enrig

Full names: Deferasirox, Enrig, Deferasirox, Desirox

Indications: For the treatment of chronic iron overload in patients with beta-thalassemia older than 6 years old due to frequent blood transfusions (monthly administration of concentrated red blood cells ≥7 mL/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 situation of the patient.

Usage and Dosage: Starting dose: The recommended starting daily dose of deferasirox is 20 mg/kg. For patients who receive monthly transfusions of more than 14 mL/kg of packed red blood cells (i.e., more than 4 units/month in adults) and who need to reduce excess iron exposure, 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 (i.e., less than 2 units/month in adults) and who need to maintain body iron balance, a starting dose of 10 mg/kg/day may be considered. In patients who have already responded well to deferoxamine therapy, an initial dose of Enriga equivalent to half the deferoxamine dose may be considered. (For example, a patient receiving deferoxamine 40 mg/kg/day, 5 days a week or equivalent, may start with 20 mg/kg if switched to Enriga.)

How to take: Deferasirox should be taken on an empty stomach at least 30 minutes before a meal, once a day, preferably at the same time every day. Tablets should not be chewed or swallowed whole. Deferasirox should not be taken with aluminum-containing antacids, and the dose (mg/kg) needs to be calculated and rounded to the nearest whole tablet. Completely dissolve the tablets in water, apple juice or orange juice (100-200mL) by stirring until a clear suspension is obtained and then drink it. The remaining medicine must be added with a small amount of water, apple juice or orange juice and mixed well before taking. Not recommended for dissolution in carbonated drinks or milk as it can cause foaming and slow dispersion.

Precautions: 1. Use with caution in elderly patients with reduced liver and kidney function, pregnant and lactating women, and children under 6 years old. Not suitable for use by children under 2 years old. 2. During the medication period, liver and kidney function indicators, platelet count, hearing and vision need to be monitored regularly.

Contraindications 1. It is prohibited for those 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; patients with poor general condition, high-risk myelodysplastic syndrome (MDS) or advanced malignant tumors; patients with platelet count <50x109/L.

The above is the content of the instructions for use, I hope it can help you!