Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 QT Prolongation
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
WARNING: RENAL, HEPATIC FAILURE AND/OR GASTROINTESTINAL HEMORRHAGE
Exjade may cause:
renal impairment, including failure
hepatic impairment, including failure
gastrointestinal hemorrhageIn some reported cases, these reactions were fatal. These reactionswere more frequently observed in patients with advanced age, high risk myelodysplastic syndromes (MDS), underlying renal or hepatic impairment or low platelet counts (<50 x 109/L) [see Contraindications (4), Warnings and Precautions (5.1- 5.7)]. Exjade therapy requires close patient monitoring, including measurement of:
serum creatinine and/or creatinine clearance prior to initiation of therapy and monthly thereafter; in patients with underlying renal impairment or risk factors for renal impairment, monitor creatinine and/or creatinine clearance weekly for the first month, then monthly thereafter;
serum transaminases and bilirubin prior to initiation of therapy, every two weeks during the first month and monthly thereafter.
1 INDICATIONS AND USAGE
Exjade (deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2years of age and older.In these patients, Exjade has been shown to reduce liver iron concentration and serum ferritin levels. Clinical trials to demonstrate increased survival or to confirm clinical benefit have not been completed [see Clinical Studies (14)].
Individualize the decision to initiate Exjade therapy based on consideration of the anticipated clinical benefit and risks of the therapy, taking into consideration factors such as the life expectancy and comorbidities of the patient [see Warnings and Precautions (5.1- 5.6) and Contraindications (4)].
The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
Prior to starting therapy, obtain baseline serum ferritin and iron levels. The risk for toxicity may be increased when Exjade is given to patients with low iron burden or with serum ferritin levels that are only slightly elevated [see Dose Modifications (2.2)].
The recommended initial daily dose of Exjade is 20mg/kg body weight.
Take Exjade once daily on an empty stomach at least 30minutes 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 <1g in 3.5ounces of liquid and doses of ≥1g in 7.0ounces 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 clin |
