Desirox国内上市没?
It was approved by the FDA in November 2005 for use in patients 2 years and older with chronic iron overload caused by blood transfusions.
Desirox was approved by the European Commission in December 2012 for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndrome who require chelation therapy due to contraindications or insufficiency of deferoxamine mesylate therapy.
On January 23, 2013, the FDA approved a new indication for Desirox for the treatment of chronic iron overload in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT).
So, has Desirox been launched in China?
In 2010, Desirox was approved for marketing in China for the treatment of chronic iron overload in beta-thalassemia patients older than 6 years old due to frequent blood transfusions (monthly dosage 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.
Patients taking Desirox need to note:
1. Desirox is associated with potentially severe reductions in white blood cell and platelet counts, especially in people with pre-existing blood abnormalities.
2. Desirox can cause hearing loss and eye disease only in rare cases. You should have a complete hearing and eye exam before starting to use Desirox and, thereafter, annual checkups.
3. People taking Desirox have experienced gastrointestinal bleeding and ulcers, including some children and adolescents. Taking Desirox with blood thinners or other drugs that irritate the gastrointestinal tract, such as corticosteroids and bisphosphonates, increases the risk.
4. Use may cause skin rash. If the condition is severe, the medication may need to be stopped temporarily and then restarted at a lower dose.
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