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U.S. Department of Health and Human Services

Safety

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Viread (tenofovir disoproxil fumarate) Tablets August 2008


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

  • Exacerbation of Hepatitis after Discontinuation of Treatment
  • Coadministration with Other Products
  • Patients Coinfected with HIV-1 and HBV
  • Decreases in Bone Mineral Density
  • Fat Redistribution
  • Immune Reconstitution Syndrome

ADVERSE REACTIONS

  • Adverse Reactions from Clinical Trials Experience
    • Clinical Trials in Patients with Chronic Hepatitis B
      • Treatment-Emergent Adverse Reactions
      • Laboratory Abnormailities
    • Table 8 (and text following Table 8)

DRUG INTERACTIONS

  • Drugs Affecting Renal Function
    • In the treatment of chronic hepatitis B, Viread should not be administered in combination with Hepsera (adefovir dipivoxil).

PATIENT COUNSELING INFORMATION

  • Information for Patients
  • Patients should be advised that:
    • The use of Viread has not been shown to reduce the risk of transmission of HIV-1 or HBV to others...
    • Viread should not be discontinued without first informing their physician.
    • If you have HIV-1 infection, with or without HBV coinfection, it is important to take Viread with combination therapy.
    • Severe acute exacerbations of hepatitis have been reported in patients who are infected with HBV or coinfected with HBV and HIV-1...
    • In patients with chronic hepatitis B, it is important to obtain HIV antibody testing prior to initiating Viread...
    • Viread should not be administered in combination with Hepsera...
    • Decreases in bone mineral density have been observed with the use of Viread in patients with HIV...
    • In the treatment of chronic hepatitis B, the optimal duration of treatment is unknown. The relationship between response and long-term prevention of outcomes such as hepatocellular carcinoma is not known.

PATIENT PACKAGE INSERT

  • What is Viread and how does it work?
    • Use in the Treatment of HIV-1 Infection
    • Use in the Treatment of Chronic Hepatitis B
  • Does Viread cure HIV-1 or AIDS?
  • Does Viread reduce the risk of passing HIV-1 or HBV to others?
  • Who should not take Viread?
  • What should I tell my healthcare provider before taking Viread?
  • How should I take Viread?
  • What are the possible side effects of Viread?

BOXED WARNING

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

...Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including Viread. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including Viread. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].

WARNINGS AND PRECAUTIONS

Exacerbation of Hepatitis after Discontinuation of Treatment

Discontinuation of anti-HBV therapy, including Viread, may be associated with severe acute exacerbations of hepatitis. Patients infected with HBV who discontinue Viread should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Coadministration with Other Products

...Viread should not be administered in combination with Hepsera (adefovir dipivoxil) [See Drug Interactions (7.4)].

Patients Coinfected with HIV-1 and HBV

Due to the risk of development of HIV-1 resistance, Viread should only be used in HIV-1 and HBV coinfected patients as part of an appropriate antiretroviral combination regimen.

HIV-1 antibody testing should be offered to all HBV-infected patients before initiating therapy with Viread. It is also recommended that all patients with HIV-1 be tested for the presence of chronic hepatitis B before initiating treatment with Viread.

Decreases in Bone Mineral Density

...The bone effects of Viread have not been studied in patients with chronic HBV infection.

Fat Redistribution

In HIV-infected patients redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving combination antiretroviral therapy...

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in HIV-infected patients treated with combination antiretroviral therapy, including Viread...