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Renal failure: Acute renal failure (including fatalities and case requiring dialysis) may occur; observed more frequently in patients with comorbid conditions and advanced hematologic malignancies. Obtain serum creatinine and calculate CrCl in duplicate at baseline prior to initiation and monitor at least monthly thereafter; in patients with underlying renal dysfunction or at risk for acute renal failure, monitor creatinine weekly during the first month and then at least monthly thereafter. Dose reduction, interruption or discontinuation should be considered for serum creatinine elevations. Monitor serum creatinine and/or CrCl more frequently if creatinine levels are increasing. May cause proteinuria; monitor monthly although the clinical significance of proteinuria is unknown. Renal tubular damage, including Fanconi syndrome, has also been reported, primarily in pediatric/adolescent patients with beta-thalassemia and serum ferritin level less than 1,500 mcg/L.
Hepatic failure: Hepatic injury and failure (including fatalities) may occur. Monitor transaminases and bilirubin at baseline, every 2 weeks for 1 month, then at least monthly thereafter. Hepatitis and elevated transaminases have also been reported. Hepatotoxicity is more common in patients older than 55 years and in patients with significant comorbidities (eg, cirrhosis, multiorgan failure). Reduce dose or temporarily interrupt treatment for severe or persistent increases in transaminases/bilirubin.
Heart failure: The Canadian labeling recommends against use in patients with acute heart failure associated with iron overload (has not been studied).
Gastrointestinal events: GI hemorrhage (including fatalities) may occur; observed more frequently in elderly patients with advanced hematologic malignancies and/or low platelet counts; discontinue treatment for suspected GI hemorrhage or ulceration. Other GI effects including irritation and ulceration (sometimes complicated with GI perforation, including fatalities) have been reported. Use caution with concurrent medications that may increase risk of adverse GI effects (eg, NSAIDs, corticosteroids, anticoagulants, oral bisphosphonates). Monitor patients closely for signs/symptoms of GI ulceration/bleeding.
Bone marrow suppression: Cytopenias (including agranulocytosis, neutropenia, thrombocytopenia and worsening anemia) have been reported (some fatal); risk may be increased in patients with preexisting hematologic disorders; monitor blood cell counts regularly. Interrupt treatment in patients who develop cytopenias; may reinitiate once cause of cytopenia has been determined; use is contraindicated if platelet count less than 50,000/mm3.
Dermatologic toxicity: May cause skin rash (dose related); mild to moderate rashes may resolve without treatment interruption; for severe rash, interrupt and consider restarting at a lower dose with dose escalation and oral steroids. Severe skin reactions, including Stevens-Johnson and erythema multiforme, have also been reported; if suspected, discontinue immediately and evaluate. Do not reintroduce therapy.
Auditory disturbances: Decreased hearing and high frequency hearing loss have been reported (rare) with use; perform auditory testing prior to initiation and regularly (every 12 months) during use. If abnormalities develop monitor more closely and consider dose reduction or treatment interruption.
Ocular disturbances: Lens cataracts, intraocular pressure elevation and retinal disorders have been reported (rare) use; perform ophthalmic testing prior to initiation and regularly (every 12 months) during use. If abnormalities develop, monitor more closely and consider dose reduction or treatment interruption.
Other minerals: Deferasirox has a low affinity for binding with zinc and copper, may cause variable of disease in the serum concentration of these trace minerals.
Hypersensitivity reactions: Hypersensitivity reactions, including severe reactions (anaphylaxis and angioedema) have been reported; onset is usually within the first month of treatment. Discontinue if severe.
Renal function impairment: Use with caution in patients with renal impairment. Dosage modification or treatment discontinuation may be required; reductions in initial dose are recommended for patients with CrCl 40 to 60 ml/minute; use is contraindicated in patients with a CrCl less than 40 mL/minute or serum creatinine more than 2 times age-appropriate ULN.
Hepatic function impairment: Avoid use in patients with severe (Child-Pugh class C) hepatic impairment; a dose reduction is required in patients with moderate (Child-Pugh class B) hepatic impairment. Monitor patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) impairment closely for efficacy and for adverse reactions requiring dosage reduction.
Monitoring: Serum ferritin (baseline, monthly thereafter), iron levels (baseline), CBC with differential, serum creatinine and CrCl (2 baseline assessments then monthly thereafter; in patients who are at increased risk of complications [eg, preexisting renal conditions, elderly, comorbid conditions or receiving other potentially nephrotoxic medications]: weekly for the first month then at least monthly thereafter); liver iron concentration (non-transfusion-dependent thalassemia; baseline, every 6 months); urine protein (monthly); monitor serum creatinine and/or CrCl more frequently if creatinine levels are increasing; serum transaminases (ALT/AST) and bilirubin (baseline every 2 weeks for the first month, then monthly); baseline and annual auditory and ophthalmic examination (including slit-lamp examinations and dilated fundoscopy): performance status (in patients with hematologic malignancies); signs/symptoms of GI ulcers or hemorrhage; cumulative number of RBC units receive.
Use in Elderly: Use with caution due to the higher incidence of toxicity (eg, hepatotoxicity) and fatal events during use; monitor elderly patients closely.
