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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.|
|Sections Modified||Summary of Changes to Contraindications and Warnings|
WARNINGS AND PRECAUTIONS
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
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.
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...