Derm: rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), ERYTHEMA MULTIFORME, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.
EENT: ↑intraocular pressure, cataracts, hearing loss, lens opacities, retinal disorders.
GI: diarrhea, nausea , vomiting, ↑ liver enzymes, abdominal pain, drug-induced hepatitis, GI BLEEDING/ULCERATION, GI PERFORATION, HEPATOTOXICITY.
GU: ↑serum creatinine, RENAL FAILURE, renal failure.
Hemat: agranulocytosis, neutropenia, thrombocytopenia, worsening anemia.
MS: arthralgia.
Neuro: headache, dizziness.
Resp: cough.
Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).
Chronic Iron Overload Due to Blood Transfusions
- PO (Adults and Children 2 yr): Exjade: 20 mg/kg once daily; adjusted by 510 mg/kg every 36 mo on the basis of serum ferritin levels (not to exceed 40 mg/kg/day); Jadenu: 14 mg/kg once daily; adjusted by 3.57 mg/kg every 36 mo on the basis of serum ferritin levels (not to exceed 28 mg/kg/day).
Hepatic Impairment
- (Adults and Children 2 yr): Moderate hepatic impairment (Child-Pugh B): ↓initial dose by 50%.
Renal Impairment
- (Adults and Children 2 yr): CCr 4060 mL/min: ↓initial dose by 50%.
Chronic Iron Overload in Non-Transfusion Dependent Thalassemia Syndromes
- PO (Adults and Children 10 yr): Exjade: 10 mg/kg once daily; if baseline liver iron concentration >15 mg/g of liver dry weight, consider ↑ dose to 20 mg/kg/day after 4 wk. If liver iron concentration remains >7 mg/g of liver dry weight after 6 mo, ↑ dose to 20 mg/kg/day (maximum dose). If liver iron concentration is 37 mg/g of liver dry weight after 6 mo, continue therapy with no more than 10 mg/kg/day. When liver iron concentration <3 mg/g of liver dry weight, may discontinue therapy (restart when liver iron concentration >5 mg/g of liver dry weight); Jadenu: 7 mg/kg once daily; if baseline liver iron concentration >15 mg/g of liver dry weight, consider ↑ dose to 14 mg/kg/day after 4 wk. If liver iron concentration remains >7 mg/g of liver dry weight after 6 mo, ↑ dose to 14 mg/kg/day (maximum dose). If liver iron concentration is 37 mg/g of liver dry weight after 6 mo, continue therapy with no more than 7 mg/kg/day. When liver iron concentration <3 mg/g of liver dry weight, may discontinue therapy (restart when liver iron concentration >5 mg/g of liver dry weight).
Hepatic Impairment
- (Adults and Children 10 yr): Moderate hepatic impairment (Child-Pugh B): ↓initial dose by 50%.
Renal Impairment
- (Adults and Children 2 yr): CCr 4060 mL/min: ↓initial dose by 50%.
Therapeutic Classification: antidotes
Pharmacologic Classification: chelating agents
Absorption: Well absorbed (70%) following oral administration, absorption is less in children.
Distribution: Unknown.
Protein Binding: 99%.
Metabolism/Excretion: Mostly metabolized by the liver, followed by enterohepatic recycling. 84% excreted in feces (deferasirox and metabolites); minimal renal excretion.
Half-life: 816 hr.