Deferasirox中文版说明书

Chinese version manual

Generic name: Deferasirox

Product name: Enrig

Full names: Deferasirox, Enrig, Deferasirox, Desirox

Deferasirox (deferasirox, Enrig) indications:

1. Patients with chronic iron overload transfusion hemosiderinosis secondary to blood transfusion who are 2 years old or older will develop symptoms of chronic iron overload when serum ferritin continues to be >1000 L. At this time, iron chelation therapy should be started.

2. Patients receiving ASCT can also be given iron chelator therapy when iron overload occurs;

3. Can be used to treat reversible renal insufficiency caused by Fanconi syndrome.

Deferasirox (Deferasirox, Enrig) dosage:

The common starting dose 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 disease. Administer on an empty stomach 30 minutes before meals and should be completely dissolved in water or apple or orange juice.

Lower doses of Deferasirox (Deferasirox, Enriga) [5-10 mg/(kg·d)] can only be used for young patients with mild iron overload and few blood transfusions, or elderly patients who have not received satisfactory results from chelation therapy in the past; patients using Deferasirox 20 and 30 mg/(kg·d) need to carefully monitor body iron stores, because body iron levels may continue to rise in 50% and 10% of patients.

In addition, the frequency of blood transfusions can also affect the effect of Deferasirox (Deferasirox, Enrig) in controlling liver concentrations. When the iron intake is greater than 0.5 mg/(kg·d), only 47% of patients who received the same dose of Deferasirox (Deferasirox, Enrig) achieved a reduction in liver concentrations.

Deferasirox (Deferasirox, Enrig) side effects: Common adverse reactions: diarrhea, vomiting, headache, abdominal pain, fever, rash, increased serum creatinine, etc. Other adverse reactions: increased liver enzymes, cough, throat inflammation, urticaria.

Deferasirox (Deferasirox, Enrig) Precautions:

1. Deferasirox (Deferasirox, Enriga) may cause rash. Generally, the rash will disappear automatically without the need to adjust the dosage or stop the medication; if the situation 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. Deferasirox (Deferasirox, Enrig) ​​dispersible tablets should be avoided combined with strong inducers of UDP-glucuronosyltransferase (UGT) (such as rifampicin, phenytoin, sedatives and hypnotics, protease inhibitors) and cholestyramine. Nor should it be administered with aluminum-containing antacids. Deferasirox dispersible tablets should not be combined with other iron chelation treatments.

4. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme have also been reported; the risk of other skin reactions including drug reactions with eosinophilia and systemic symptoms cannot be excluded. 

Myelosuppression: Cytopenia (including agranulocytosis, neutropenia, thrombocytopenia, and worsening anemia) (some fatal) has been reported; patients with pre-existing blood disorders may be at increased risk; monitor blood counts regularly. Interrupt treatment in patients who develop cytopenia; may restart once cause of cytopenia is determined; if platelet count<50,000/mm3 is disabled. 

6. Gastrointestinal events: Gastrointestinal bleeding (including death) may occur; more common in patients with advanced hematological malignancies and/or elderly patients with low platelet counts; discontinue treatment for suspected gastrointestinal bleeding or ulceration. Monitor patients closely for signs/symptoms of gastrointestinal ulceration/bleeding while taking Deferasirox.

The above is the content of the instructions for (Deferasirox, Enrego), I hope it can help you!