Exjade (Deferasirox) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.  

Starting Dose

The recommended initial daily dose of Exjade is 20 mg/kg body weight.

Maintenance

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.

Administration Instructions

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.

HOW SUPPLIED

Exjade^® (deferasirox) Tablets for Oral Suspension

125 mg

Off-white, round, flat tablet with beveled edge and imprinted with “J” and “125” on one side and “NVR” on the other.

Bottles of 30 tablets …………………………………………….………………. (NDC 0078-0468-15)

250 mg

Off-white, round, flat tablet with beveled edge and imprinted with “J” and “250” on one side and “NVR” on the other.

Bottles of 30 tablets …………………………………………….………………. (NDC 0078-0469-15)

500 mg

Off-white, round, flat tablet with beveled edge and imprinted with “J” and “500” on one side and “NVR” on the other.

Bottles of 30 tablets …………………………………………….………………. (NDC 0078-0470-15)

Storage

Store at 25°C (77°F). Excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture. 

Manufactured by:

Novartis Pharma Stein AG

Stein, Switzerland

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

REV:   DECEMBER 2007

©Novartis