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U.S. Department of Health and Human Services

Safety

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Viread (tenofovir disoproxil fumarate) Tablets November 2008

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
  • 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 PACKAGE INSERT

  • What are the possible side effects for Viread?
    • Marketing experience: Other side effects reported since Viread has been marketed include...
    • ...Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.
    • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response...

BOXED WARNING

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

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

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.