Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 162.5 mg of white to almost white granules, equivalent to 90 mg deferasirox.

Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 325 mg of white to almost white granules, equivalent to 180 mg deferasirox.

Supplied in cartons containing 30 child resistant foil sachets. Each sachet contains 650 mg of white to almost white granules, equivalent to 360 mg deferasirox.

Deferasirox is contraindicated in patients with:

The following clinically significant adverse reactions are also discussed in other sections of the labeling:

Cases of overdose (2 to 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. In one pediatric case, a dose of 2-3 times the prescribed dose for 6 days resulted in acute renal failure requiring hemofiltration and acute liver injury/failure, which were reversible with intensive care support. Single doses of deferasirox up to 80 mg per kg per day with the tablet for oral suspension formulation in iron-overloaded beta-thalassemic patients have been tolerated with nausea and diarrhea noted. In healthy subjects, single doses of up to 40 mg per kg per day with the tablet for oral suspension formulation were tolerated.

Early signs of acute overdose are digestive effects such as abdominal pain, diarrhea, nausea, and vomiting. Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation. An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.

Deferasirox is an iron-chelating agent provided as a granules for oral use. Deferasirox is designated chemically as 4-[3,5-bis(2-hydroxyphenyl)-1

Deferasirox is a white to slightly yellow powder. It has a molecular formula C

Deferasirox was evaluated in healthy subjects. There are no clinical data in patients with deferasirox. Deferasirox contains the same active ingredient as deferasirox tablets for oral suspension. The following information is based on clinical trials conducted with deferasirox tablets for oral suspension.

Study 6 (NCT00873041) was an open-label trial of deferasirox tablets for oral suspension for the treatment of patients previously enrolled on Study 5, including cross-over to active treatment for those previously treated with placebo. The starting dose of deferasirox tablets for oral suspension in Study 6 was assigned based on the patient’s LIC at completion of Study 5, being 20 mg/kg/day for an LIC exceeding 15 mg Fe/g dw, 10 mg/kg/day for LIC 3 to 15 mg Fe/g dw, and observation if the LIC was less than 3 mg Fe/g dw. Patients could continue on 5 mg/kg/day if they had previously exhibited at least a 30% reduction in LIC. Doses could be increased to a maximum of 20 mg/kg/day after 6 months if the LIC was more than 7 mg Fe/g dw and the LIC reduction from baseline was less than 15%. The primary efficacy endpoint in Study 6 was the proportion of patients achieving an LIC less than 5 mg Fe/g dw. A total of 133 patients were enrolled. Twenty patients began Study 6 with an LIC less than 5 mg Fe/g dw. Of the 113 patients with a baseline LIC of at least 5 mg Fe/g dw in Study 6, the target LIC (less than 5 mg Fe/g dw) was reached by 39 patients (35%). The responders included 4 (10%) of 39 patients treated at 20 mg/kg/day for a baseline LIC exceeding 15 mg Fe/g dw, and 31 (51%) of 61 patients treated at 10 mg/kg/day for a baseline LIC between 5 and 15 mg Fe/g dw. The absolute change in LIC at Week 52 by starting dose is shown in Table 5 below.

Deferasirox oral granules 90 mg are white to almost white granules in sachet. They are available in cartons of 30 sachets………………………………………………..(NDC 72205-176-30).

Deferasirox oral granules 180 mg are white to almost white granules in sachet.They are available in cartons of 30 sachets………………………………………………..(NDC 72205-075-30).

Deferasirox oral granules 360 mg are white to almost white granules in sachet. They are available in cartons of 30 sachets………………………………………………..(NDC 72205-076-30).

Store deferasirox oral granules at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).