A total of 195patients were treated in this study: 132 with Exjade and 63 with deferoxamine. 44% of patients were <16years of age and 91% were Black. At end of study, the mean change in LIC (as measured by magnetic susceptometry by a superconducting quantum interference device) in the per protocol-1 (PP-1) population, which consisted of patients who had at least one postbaseline LIC assessment, was -1.3 mg Fe/g dry weight for patients receiving Exjade (n=113) and -0.7mg Fe/g dry weight for patients receiving deferoxamine (n=54).

16 HOW SUPPLIED/STORAGE AND HANDLING
Exjade is provided as 125mg, 250mg, and 500mg tablets for oral suspension.

125mg

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………………………………………………………………..(NDC0078-0468-15)

250mg

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………………………………………………………………..(NDC0078-0469-15)

500mg

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………………………………………………………………..(NDC0078-0470-15)

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

17 PATIENT COUNSELING INFORMATION
Advise patients to take Exjade once daily on an empty stomach at least 30minutes prior to food, preferably at the same time every day. Instruct patients to completely disperse the tablets in water, orange juice, or apple juice, and drink the resulting suspension immediately. After the suspension has been swallowed, resuspend any residue in a small volume of the liquid and swallow.

Advise patients not to chew tablets or swallow them whole.

Advise patients who experience diarrhea or vomiting to maintain adequate hydration.

Caution patients not to take aluminum-containing antacids and Exjade simultaneously.

Because auditory and ocular disturbances have been reported with Exjade, conduct auditory testing and ophthalmic testing before starting Exjade treatment and thereafter at regular intervals [see Warnings and Precautions(5.8)].

Caution patients experiencing dizziness to avoid driving or operating machinery [see Adverse Reactions(6.1)].

Caution patients about the potential for the development of GI ulcers or bleeding when taking Exjade in combination with drugs that have ulcerogenic or hemorr