Label Changes for:

Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets

November 2008

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

BOXED WARNING

WARNINGS AND PRECAUTIONS

  • Lactic Acidosis/Severe Hepatomegaly with Steatosis
  • Coadministration with Other Products
  • Decreases in Bone Mineral Density
  • Early Virologic Failure (new subsection)

ADVERSE REACTIONS

  • Postmarketing Experience (see highlighted label for specific changes)
    • Metabolism and Nutrition Disorders
    • Hepatobiliary Disorders
    • Musculoskeletal and Connective Tissue Disorders
    • Renal and Urinary Disorders
  • The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy...

PATIENT COUNSELING INFORMATION

  • Information for Patients
    • Patients should be advised that:
      • Truvada should not be administered with Hepsera [See Warnings and Precautions (5.4)].

PATIENT PACKAGE INSERT

  • Who should not take Truvada?
    • Do not take Truvada to treat your HIV infection if you are also taking Hepsera to treat your HBV infection.
  • What should I avoid while taking Truvada?
    • Truvada should not be used with Hepsera.
  • What are the possible side effects of Truvada?
    • "Flare-ups" of Hepatitis B Virus Infection...
    • Changes in bone mineral density (thinning bones)...
    • Other side effects with Truvada when used with other anti-HIV-1 medicines include...
    • The most common side effects of Emtriva or Viread when used with other anti-HIV-1 medicines...

BOXED WARNING

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals [See Warnings and Precautions (5.1)]...

WARNINGS AND PRECAUTIONS

Lactic Acidosis/Severe Hepatomegaly with Steatosis:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals.

Coadministration with Other Products:

...Truvada should not be administered with Hepsera (adefovir dipivoxil).

Decreases in Bone Mineral Density:

...Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures have been reported in association with the use of Viread [See Adverse Reactions (6.2)].

Early Virologic Failure:

Clinical studies in HIV-infected patients have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective than triple drug regimens containing two NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor. In particular, early virological failure and high rates of resistance substitutions have been reported. Triple nucleoside regimens should therefore be used with caution. Patients on a therapy utilizing a triple nucleoside-only regimen should be carefully monitored and considered for treatment modification.

 

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