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U.S. Department of Health and Human Services

Safety

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Hepsera (adefovir dipivoxil) Tablets


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Clinical Resistance (new subsection)

ADVERSE REACTIONS

  • Clinical Trials Experience
    • For 65 patients who chose to continue Hepsera for up to 240 weeks in Study 437, 6 had a confirmed increase in serum creatinine of >0.5 mg/dL from baseline with 2 patients discontinuing from the study due to the elevated serum creatinine concentration.
  • Postmarketing Experience (new subsection)

PATIENT COUNSELING INFORMATION

  • Lamivudine-resistant patients should use Hepsera in combination with lamivudine and not as Hepsera monotherapy [See Warnings and
    Precautions. (5.5)]

WARNINGS AND PRECAUTIONS

Clinical Resistance

Resistance to adefovir dipivoxil can result in viral load rebound which may result in exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to liver decompensation and possible fatal outcome.

In order to reduce the risk of resistance in patients with lamivudine resistant HBV, adefovir dipivoxil should be used in combination with lamivudine and not as adefovir dipivoxil monotherapy.

Long-term (144 week) data from Study 438 (n=124) show that patients with HBV DNA levels greater than 1000 copies/mL at Week 48 of treatment with Hepsera were at greater risk of developing resistance than patients with serum HBV DNA levels below 1000 copies/mL at Week 48 of therapy.

 

Label approved 05/27/2008 is not available on Drugs@FDA