Adefovir Dipivoxil: ADVERSE REACTIONS

In: Main

25 Jun 2010

Table 5 lists all treatment-related clinical adverse events that occurred in 3% or more of the Hepsera™-treated patients compared with those receiving placebo. Increased asthenia, headache, and abdominal pain are the most frequently reported adverse events, followed by nausea and flatulence. Two other less commonly reported side effects are diarrhea and dyspepsia.

CONTRAINDICATIONS AND PRECAUTIONS

Hepsera™ is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. Severe acute exacerbation of hepatitis has been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with this drug. In clinical trials of Hep-sera™, exacerbations of hepatitis occurred in up to 25% of patients after discontinuation of therapy, with most of these events occurring within 12 weeks of discontinuation. Although most of the adverse events were resolved with re-initiation of treatment, severe hepatitis exacerbations and fatalities have been reported. Therefore, patients who discontinue drug therapy should be closely monitored for hepatic function at repeated intervals over a period of time. canadian cialis online

Table 5   Treatment-Related Adverse Events Reported in 3% or More of All Patients Given Adefovir Dipivoxil (ADV) in Pooled Studies 437 and 438 (0-48 Weeks)

ADV 10 mg (n = 294)

Placebo (n = 228)
Asthenia 13%

14%

Headache 9%

10%

Abdominal pain 9%

11%

Nausea 5%

8%

Flatulence 4%

4%

Diarrhea 3%

4%

Dyspepsia 3%

2%

Data from Hepsera™ prescribing informa­tion. Gilead Sciences, Inc., September 2002.4

PREGNANCY AND LACTATION

No data are available regarding the use of adefovir in pregnant patients; there are no data on whether it is excreted in breast milk. The drug should be used during pregnancy only if it is clearly needed and only after careful consideration of the risks and benefits. Mothers should be instructed not to breast-feed while they are taking Hepsera™.

CONCLUSION

It is expected that Hepsera™ will be used to treat adults with chronic HBV infection, patients with HIV/HBV co-infection, and patients with resistance. The recommended dose in patients with chronic hepatitis B and with adequate renal function is 10 mg, once daily, taken orally. The optimal duration of treatment is unknown. Hep-sera™ appears to offer a significant alternative to other HBV agents that are associated with high resistance. Resistance to Hepsera™ has not yet been documented, and it appears to be a potentially viable agent against HBV infection.


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