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U.S. Department of Health and Human Services

Safety

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Exjade (deferasirox) Tablets for Oral Suspension October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

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.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Renal
  • Gastrointestinal (new subsection)

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Table 1
    • Table 2
    • ...In the population of more than 5,000 patients who have been treated with Exjade during clinical trials...

DRUG INTERACTIONS

  • In healthy volunteers, the concomitant administration of Exjade and midazolam (a CYP3A4 probe substrate)...

PATIENT COUNSELING INFORMATION

  • Other Information

 

WARNINGS AND PRECAUTIONS

Renal:

...In the clinical studies, Exjade-treated patients experienced dose-dependent increases in serum creatinine. These increases occurred at a greater frequency compared to deferoxamine-treated patients (38% vs. 14%, respectively, in Study 1 and 36% vs 22%, respectively, in Study 3). Most of the creatinine elevations remained within the normal range [see Adverse Reactions (6.1)]. There have also been reports of renal tubulopathy in patients treated with Exjade...

Gastrointestinal:

Gastrointestinal (GI) irritation may occur during Exjade treatment. Upper GI ulceration and hemorrhage have been reported in patients, including children and adolescents, receiving Exjade [See Adverse Reactions (6.1)]. Physicians and patients should remain alert for signs and symptoms of GI ulceration and hemorrhage during Exjade therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. Use caution when administering Exjade in combination with drugs that have ulcerogenic or hemorrhagic potential, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants.
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