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本帖最后由 风雨不动 于 2012-4-14 15:27 编辑
FDA has approved changes in product labeling for Tyzeka® (telbivudine) 600
mg tablets and Tyzeka® (telbivudine) oral solution 100 mg/5 mL related to
a higher risk of developing resistance-associated substitutions in treated
patients. Indications and Usage-Under Section 1.1 Chronic Hepatitis B The
following points should be considered when initiating therapy with
Tyzeka”: • For HBeAg-positive patients, Tyzeka should only be initiated
in patients with HBV DNA less than 9 log10 copies/mL and ALT greater than
or equal to 2x Upper Limit of Normal (ULN) prior to treatment. • For
HBeAg-negative patients, Tyzeka should only be initiated in patients with
HBV DNA less than 7 log10 copies/mL prior to treatment. • On-treatment
response should guide continued therapy [see Dosage and Administration
(2.1) and Microbiology (12.4)]. Dosage and Administration-Under Section 2.1
Adults and Adolescents (16 years of age and older): Due to higher rates of
resistance that may develop with longer term treatment among patients with
incomplete viral suppression, treatment should only be initiated, if
pre-treatment HBV DNA and ALT measurements are known, in the following
patient populations: For HBeAg-positive patients, HBV DNA should be less
than 9 log10 copies/mL and ALT should be greater than or equal to 2x ULN
prior to treatment with Tyzeka. For HBeAg-negative patients, HBV DNA should
be less than 7 log10 copies/mL prior to treatment with Tyzeka.
HBV DNA levels should be monitored at 24 weeks of treatment to assure
complete viral suppression (HBV DNA less than 300 copies/mL). Alternate
therapy should be initiated for patients who have detectable HBV DNA after
24 weeks of treatment. Optimal therapy should be guided by further
resistance testing. Dosage and Administration-Under Section 2.4-Duration of
Therapy: For patients with incomplete viral suppression (HBV DNA greater
than or equal to 300 copies/mL) after 24 weeks of treatment, alternate
therapy should be instituted. HBV DNA should be monitored every 6 months to
assure continued response. If patients test positive for HBV DNA at any
time after their initial response, alternate treatment should be
instituted. Optimal therapy should be guided by resistance testing. For
more information on the role of Tyzeka in the treatment of of hepatitis,
please see the American Association for the Study of Liver Diseases (AASLD)
Practice Guidelines for Management of Chronic Hepatitis B Richard Klein
Office of Special Health Issues Food and Drug Administration Kimberly
Struble Division of Antiviral Drug Products Food and Drug Administration
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发表于 2011-4-2 05:31
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