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发表于 2002-9-26 04:01
HEPSERATM (adefovir dipivoxil) is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
Warnings:
1. Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with HEPSERA. Hepatic function should be monitored closely in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
2. In patients at risk of or having underlying renal dysfunction, chronic administration of HEPSERA may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment.
3. HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with HEPSERA, that may have activity against HIV.
4. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.
来源:http://www.hepsera.com/abouthepsera.asp
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