United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s exjade® (deferasirox) tablets for oral suspension. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets for oral suspension when administered with other iron chelation therapy have not been established. deferasirox tablets for oral suspension are contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1, 5.3)] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelatio

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox when administered with other iron chelation therapy have not been  established. deferasirox  is contraindicated in patients with: ·         estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; ·         poor performance status; [see warnings and precautions (5.1, 5.3)] ·         high-risk myelodysplastic syndromes; (this patient population was not studied and is not expected to benefit from chelation th

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s jadenu® (deferasirox) tablets. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; • poor performance status [see warnings and precautions (5.1, 5.3)]; • high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); • advanced malignancies [see warnings and precautions (5

United States - English - NLM (National Library of Medicine)

msn laboratories private limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5) , warnings and precautions (5.1) ]; - poor performance status [see warnings and precautions (5.1, 5.3 )]; - high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); - advanced maligna

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: -   estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; -   poor performance status [see warnings and precautions (5.1, 5.3)]; -   high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); -   adv

United States - English - NLM (National Library of Medicine)

msn laboratories private limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.  deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets for oral suspension  when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5) , warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1 , 5.3 )] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not

United States - English - NLM (National Library of Medicine)

dr. reddy's laboratories inc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusiondependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5) , warnings and precautions (5.1) ]; - poor performance status [see warnings and precautions (5.1, 5.3 )]; - high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); - advanced malignan

United States - English - NLM (National Library of Medicine)

bionpharma inc. - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m 2  [see dosage and administration ( 2.5) , warnings and precautions ( 5.1)] ; - poor performance status;  [see warnings and precautions (

United States - English - NLM (National Library of Medicine)

dr. reddy's laboratories inc - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.  deferasirox tablets for oral suspension are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. the safety and efficacy of deferasirox tablets for oral suspension  when administered with other iron chelation therapy have not been established. deferasirox is contraindicated in patients with: - estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5) , warnings and precautions (5.1)]; - poor performance status; [see warnings and precautions (5.1 , 5.3 )] - high-risk myelodysplastic syndromes; (this patient population was not studied and is not

United States - English - NLM (National Library of Medicine)

zydus lifesciences limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. this indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg fe/g dw) and serum ferritin levels [ see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: -   est