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Minimal (<1%) Resistance
‡
In Nucleoside-naïve Patients
coadministration of BARACLUDE (entecavir) with drugs that
•
Safety and effectiveness of BARACLUDE (entecavir) in
reduce renal function or compete for active tubular secretion pediatric patients below the age of 16 years have not been
may increase serum concentrations of either entecavir or established.
the coadministered drug.
•
The safety and efficacy of BARACLUDE in liver transplant
The most common adverse events of moderate to severe
recipients are unknown. Renal function must be carefully
intensity among patients treated with BARACLUDE in clinical
monitored both before and during treatment with
trials included: headache (4%), fatigue (3%), diarrhea (1%),
BARACLUDE in a liver transplant recipient who has
and dyspepsia (1%).
received or is receiving an immunosuppressant that may
The recommended dose of BARACLUDE is 0.5 mg once daily
affect renal function, such as cyclosporine or tacrolimus.
in nucleoside-naïve adults, and 1 mg once daily in lamivudine-
•Patients should be advised that treatment with BARACLUDE
refractory adults. BARACLUDE should be administered on
has not been shown to reduce the risk of transmission of HBV
an empty stomach (at least 2 hours after a meal and at least
to others through sexual contact or blood contamination.
2 hours before the next meal). The optimal duration of treat-
•There are no adequate and well-controlled studies of
ment with BARACLUDE for patients with chronic hepatitis B
BARACLUDE administered to pregnant women. BARACLUDE
infection and the relationship between treatment and long-
should be used during pregnancy only if clearly needed
term outcomes such as cirrhosis and hepatocellular carcinoma
and after careful consideration of the risks and benefits.
are unknown.
There are no studies on the effect of BARACLUDE on
transmission of HBV from mother to infant. Therefore,
appropriate interventions should be used to prevent
neonatal acquisition of HBV. Women should be instructed
not to breast-feed if they are taking BARACLUDE.
Please see Brief Summary of Full Prescribing Information,
including boxed WARNINGS, on the following page.
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