Label Changes for:

Exjade (deferasirox) Tablets for Oral Suspension

August 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009 and August 2011

 

August 2011

 

WARNINGS AND PRECAUTIONS

Hepatic Dysfunction and Failure
  • Avoid the use of Exjade in patients with severe (Child-Pugh C) hepatic impairment. For patients with moderate (Child-Pugh B) hepatic impairment, a 50% reduction in the starting dose is recommended [see Dosage and Administration (2.2), and Use in Specific Populations (8.7)]. Closely monitor patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment for efficacy and adverse reactions that may require dose titration. 

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

 

April 2009

Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Hepatic Dysfunction and Failure

 

DRUG INTERACTIONS

 

PATIENT COUNSELING INFORMATION

 

WARNINGS and PRECAUTIONS

  • Transaminases and bilirubin should be monitored before the initiation of treatment, every 2 weeks during the first month and monthly thereafter.

 

DRUG INTERACTIONS

  • Effect of Deferasirox on Drug Metabolizing Enzymes
    • Deferasirox inhibits human CYP3A4, CYP2C8, CYP1A2...
  • Interaction with Agents Metabolized by CYP2C8
    • In a healthy volunteer study, the concomitant administration of Exjade...
  • Interaction with Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism
    • In a healthy volunteer study, the concomitant administration of Exjade
  • Highlights Section
    • Increase the dose of Exjade and monitor serum ferritin levels and clinical response for further dose modification when it is used concomitantly with potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir).
    • 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.

 

PATIENT COUNSELING INFORMATION

  • Caution patients about potential loss of effectiveness of Exjade when administered with drugs that are potent UGT inducers (e.g. rifampicin, phenytoin, phenobarbital, ritonavir). Based on serum ferritin levels and clinical response, consider increases in the dose of Exjade when concomitantly used with potent UGT inducers.
  • Perform careful monitoring of glucose levels when repaglinide is used concomitantly with Exjade. An interaction between Exjade and other CYP2C8 substrates like paclitaxel cannot be excluded.

 

 

 

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