Reports of serious adverse reactions, some with a fatal outcome, occurred in postmarketing experience, predominantly when the drug was administered to patients with advanced age, advanced disease or co-morbid conditions. Elderly patients have an increased risk of adverse events. (5.7)

ADVERSE REACTIONS
The most frequently occurring adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Based on Exjade’s mechanism of action, do not take Exjade with aluminum-containing antacid preparations. (7)

Use caution when Exjade is administered with midazolam and other drugs metabolized by CYP3A4. (7.1, 7.2)

Exjade increases repaglinide exposure. Consider repaglinide dose reduction and carefully monitor blood glucose levels when repaglinide is used concomitantly with Exjade. An interaction between Exjade and other CYP2C8 substrates cannot be excluded. (7.3)

The use of Exjade with theophylline should be avoided. Use caution when Exjade is administered with other drugs metabolized by CYP1A2. (7.4)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal studies, may cause fetal harm. (8.1)

Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.3)

Elderly: Closely monitor due to the greater frequency of decreased hepatic, renal, or cardiac function in these patients. These patients may need Exjade dose adjustments based on early signs and/or symptoms of toxicity. (8.5)

Hepatic Impairment: Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. (8.7) Reduce the starting dose in patients with moderate (Child-Pugh B) hepatic impairment by 50%. (8.7)
See 17 for PATIENT COUNSELING INFORMATION 
Revised: 08/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
WARNING: RENAL, HEPATIC FAILURE AND/OR GASTROINTESTINAL HEMORRHAGE
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Dose Modifications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Renal
5.2 Hepatic Dysfunction and Failure
5.3 Gastrointestinal
5.4 Cytopenias
5.5 Hypersensitivity
5.6 Rash
5.7 Co-morbidities5.8 Special Senses
5.9 Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience7 DRUG INTERACTIONS
7.1 Effect of Deferasirox on Drug Metabolizing Enzymes
7.2 Interaction with Midazolam and Other Agents Metabolized by CYP3A4
7.3 Interaction with Repaglinide and Other Agents Metabolized by CYP2C8
7.4 Interaction with Theophylline and Other Agents Metabolized by CYP1A2
7.5 Interaction with Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism
7.6 Interaction with Cholestyramine
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5