恩瑞格适应症有什么呢？

The chemical name is 4-[3,5-bis(2-hydroxyphenyl)-1,2,4-triazol-1-yl]benzoic acid. It is an iron chelator product developed by the Swiss pharmaceutical company Novartis. It is the first oral iron-removing agent approved by the US FDA for routine use. It is approved for use in patients ≥2 years old with chronic iron overload caused by blood transfusion. In Europe, it is recommended as a first-line drug for patients with thalassemia iron overload over 6 years old. Today let’s take a look at Enrig’s indications.

On January 23, the U.S. Food and Drug Administration (FDA) approved a new indication for Enriga (defesirol) for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT). NTDT is a mild form of thalassemia that does not require frequent blood transfusions. But over time, NTDT patients are at risk for iron overload, which can lead to fatal organ damage. The FDA also approved the marketing of FerriScan as an imaging companion diagnostic reagent from Enrig. The FDA has previously approved FerriScan for the detection of liver iron concentration (LIC), but its use in Enrig clinical studies is to screen patients for clinical treatment and manage treatment. Its use is limited to imaging and diagnostic reagents necessary for the safe and effective application of Enrig.

Enrig was previously approved for the treatment of iron overload due to transfusion in patients 2 years of age and older, and this approval allows Enrig to be used in patients with NTDT iron overload. Enrig should be used in patients with NTDT who have at least 5 mg of iron per 1 g of desiccated liver tissue. Enrig's new indication was approved by the FDA through the accelerated approval process, which allows patients to have early access to this promising new drug to treat serious or life-threatening diseases, while the company conducts additional studies to ensure Enrig's clinical effectiveness.

The commonly used starting dose of Enrig is 20 mg/(kg·d). If there is a large amount of blood transfusion and the iron increase is >0.5 mg/(kg·d) or the iron load before treatment is high, the recommended dose is 30 mg/(kg·d). If the iron increase is <0.3 mg/kg, 10-15 mg/kg/d is enough to control the condition. Administer on an empty stomach 30 minutes before meals and should be completely dissolved in water or apple or orange juice. Lower doses of Enrego [5-10 mg/(kg·d)] can only be used in young patients with mild iron overload and few blood transfusions, or in elderly patients who have not received satisfactory results from chelation therapy in the past; patients using deferasole 20 and 30 mg/(kg·d) need to carefully monitor body iron reserves, because body iron levels may continue to rise in 50% and 10% of patients. In addition, the frequency of blood transfusion can also affect the effect of Enrig in controlling liver concentration. When the iron intake is greater than 0.5mg/(kg·d), only 47% of patients who receive the same dose of Enrig have a reduction in liver concentration.

The above is the content of the indications, I hope it can help you!