Exjade (Deferasirox)

Exjade Information:

Exjade (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.Exjade should be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Tablets should not be chewed or swallowed whole. Exjade should not be taken with aluminum-containing antacid products. Doses (mg/kg per day) should be calculated to the nearest whole tablet. Tablets should be completely dispersed by stirring in water, orange juice, or apple juice until a fine suspension is obtained. Doses of <1 g should be dispersed in 3.5 ounces of liquid and doses of ≥1 g in 7.0 ounces of liquid. After swallowing the suspension, any residue should be resuspended in a small volume of liquid and swallowed. The recommended initial daily dose of Exjade is 20 mg/kg body weight. After commencing initial therapy, it is recommended that serum ferritin be monitored every month and the dose of Exjade adjusted if necessary every 3 to 6 months based on serum ferritin trends. Dose adjustments should be made in steps of 5 or 10 mg/kg and should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). If the serum ferritin falls consistently below 500 mcg/L, consideration should be given to temporarily interrupting therapy with Exjade. Doses of Exjade should not exceed 30 mg/kg per day since there is limited experience with doses above this level. Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported. In one case, this resulted in hepatitis which resolved without long-term consequences after a dose interruption. Single doses up to 80 mg/kg/day in iron overloaded β- thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy volunteers, single doses of up to 40 mg/kg/day were tolerated. There is no specific antidote for Exjade. In case of overdose, induce vomiting and gastric lavage. The decision to remove accumulated iron should be individualized based on anticipated clinical benefit and risks of Exjade therapy. In patients who are in need of iron chelation therapy, it is recommended that therapy with Exjade (deferasirox) be started when a patient has evidence of chronic iron overload, such as the transfusion of approximately 100 mL/kg of packed red blood cells (approximately 20 units for a 40-kg patient) and a serum ferritin consistently >1000 mcg/L. The bioavailability (AUC) of deferasirox was variably increased when taken with a meal. Deferasirox should be taken on an empty stomach 30 minutes before eating. Exjade tablets for oral suspension can be dispersed in water, orange juice, or apple juice.