JADENU

DEFERASIROX BIOGARAN is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 mL/kg/mois of red blood cell concentrates) in patients aged 6 years and older with beta-thalassemia major.

DEFERASIROX BIOGARAN is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:

· pediatric patients aged 2 to 5 years with beta-thalassemia major with chronic iron overload due to frequent blood transfusions (≥ 7 mL/kg/mois of red blood cell concentrates),

· adult and pediatric patients aged 2 years and older with beta-thalassemia major with chronic iron overload due to infrequent blood transfusions (< 7 mL/kg/mois of red blood cell concentrates),

· adult and pediatric patients aged 2 years and older with other types of anemias.

DEFERASIROX BIOGARAN is also indicated for the treatment of chronic iron overload requiring iron chelation therapy in patients aged 10 years and older with non-transfusion-dependent thalassemia syndromes, when deferoxamine therapy is contraindicated or inadequate.

Pregnancy

For deferasirox, there are no data on the use of this medicine in pregnant women. Studies conducted in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3). The potential clinical risk is unknown.

As a precaution, it is recommended not to use DEFERASIROX BIOGARAN during pregnancy unless there is an absolute necessity.

DEFERASIROX BIOGARAN may decrease the efficacy of hormonal contraceptives (see section 4.5). For women of childbearing potential, it is recommended to use additional or alternative non-hormonal contraceptive methods when using DEFERASIROX BIOGARAN.

Breastfeeding

In animal studies, deferasirox is rapidly excreted and in significant quantities in breast milk. However, no effect has been noted in offspring. It is unknown whether deferasirox is excreted in human breast milk. The intake of DEFERASIROX BIOGARAN during breastfeeding is not recommended.

Fertility

No data on fertility is available in men. In animals, no adverse effect on fertility has been demonstrated in males or females (see section 5.3).

DEFERASIROX BIOGARAN has a minor influence on the ability to drive vehicles and use machines. Patients suffering from uncommon side effects such as dizziness must exercise caution when driving vehicles or using machines (see section 4.8).