Deferasirox Oral

1 INDICATIONS AND USAGE Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) 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 (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [see Warnings and Precautions ( 5.1 , 5.6)] Hepatic Toxicity and Failure [see Warnings and Precautions ( 5.2 , 5.6)] GI Hemorrhage [see Warnings and Precautions ( 5.3 )] Bone Marrow Suppression [see Warnings and Precautions ( 5.4 )] Hypersensitivity [see Warnings and Precautions ( 5.7 )] Severe Skin Reactions [see Warnings and Precautions ( 5.8 )] Skin Rash [see Warnings and Precautions ( 5.9 )] Auditory and Ocular Abnormalities [see Warnings and Precautions ( 5.10 )] In patients with transfusional iron overload, the most frequently occurri...

8.1 Pregnancy Risk Summary There are no studies with the use of deferasirox in pregnant women to inform drug-associated risks. Administration of deferasirox to rats during pregnancy resulted in decreased offspring viability and an increase in renal anomalies in male offspring at doses that were about or less than the recommended human dose on a mg/m 2 basis. No fetal effects were noted in pregnant rabbits at doses equivalent to the human recommended dose on an mg/m 2 basis. Deferasirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE Renal Failure • Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. • Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m2. 5 WARNINGS AND PRECAUTIONS Acute Kidney Injury: Measure serum creatinine in duplicate before starting therapy. Monitor renal function during deferasirox therapy and reduce dose or interrupt therapy for toxicity. ( 2.1 , 2.4 , 5.1 ) Hepatic Toxicity: Monitor hepatic function. Reduce dose or interrupt therapy for toxicity. ( 5.2 ) Fatal and Nonfatal Gastrointestinal (GI) Bleeding, Ulceration, and Irritation: Risk may be greater in patients who are taking deferasirox in combination with drugs that have known ulcerogenic or hemorrhagic potential. ( 5.3 ) Bone Marrow Suppression: Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events; monitor blood counts during deferasirox therapy. Interrupt therapy for toxicity. 4 CONTRAINDICATIONS 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 ( 5.1 , 5.3 )] ; High-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); Advanced...