2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended initial daily dose of Exjade is 20 mg/kg body weight.
Take Exjade once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. Do not chew tablets or swallow them whole. Do not take Exjade with aluminum-containing antacid products. Calculate doses (mg/kg per day) to the nearest whole tablet. Completely disperse tablets by stirring in water, orange juice, or apple juice until a fine suspension is obtained. Disperse doses of <1 g in 3.5 ounces of liquid and doses of ≥1 g in 7.0 ounces of liquid. After swallowing the suspension, resuspend any residue in a small volume of liquid and swallow.
Individualize the decision to remove accumulated iron 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.
2.2 Dose Modifications
After commencing initial therapy, monitor serum ferritin every month and adjust the dose of Exjade if necessary every 3-6 months based on serum ferritin trends. Make dose adjustments in steps of 5 or 10 mg/kg and tailor adjustments to the individual patient's response and therapeutic goals (maintenance or reduction of body iron burden). In patients not adequately controlled with doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2500 mcg/L and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered. Doses above 40 mg/kg are not recommended.
If the serum ferritin falls consistently below 500 mcg/L, consider temporarily interrupting therapy with Exjade.
The risk of toxicity of Exjade may be increased when inappropriately high doses are given in patients with low iron burden or with serum ferritin levels that are only slightly elevated. The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.
Increase the dose of Exjade and monitor serum ferritin levels and clinical response for further dose modification when it is used concomitantly with potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir). Doses above 40 mg/kg are not recommended.
3 DOSAGE FORMS AND STRENGTHS
125 mg tablets
Off-white, round, flat tablet with beveled edge and imprinted with "J" and "125" on one side and "NVR" on the other.
250 mg tablets
Off-white, round, flat tablet with beveled edge and imprinted with "J" and "250" on one side and "NVR" on the other.
500 mg tablets
Off-white, round, flat tablet with beveled edge and imprinted with "J" and "500" on one side and "NVR" on the other.