Tyzeka
(telbivudine)
Articles
on Tyzeka (telbivudine)
Indication
TYZEKA® is indicated for the treatment of
chronic hepatitis B (CHB) in adult patients
with evidence of viral replication and either
evidence of persistent elevations in serum aminotransferases
(ALT or AST) or histologically active disease.
Important
Safety Information
Lactic
acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with
the use of nucleoside analogues alone or in
combination with antiretrovirals.
Severe
acute exacerbations of hepatitis B have been
reported in patients who have discontinued anti-hepatitis
B therapy, including TYZEKA. 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. If appropriate, resumption of anti-hepatitis
B therapy may be warranted.
Cases of myopathy/myositis have been reported
with TYZEKA use several weeks to months after
starting therapy. Myopathy has also been reported
with some other drugs in this class. Isolated
cases of rhabdomyolysis have been reported during
postmarketing use of TYZEKA. Physicians initiating
concomitant treatment with any drug associated
with myopathy should monitor patients closely
for any signs or symptoms of unexplained muscle
pain, tenderness, or weakness. TYZEKA therapy
should be interrupted if myopathy is suspected
and discontinued if myopathy is confirmed
Peripheral neuropathy has been reported with
telbivudine alone or in combination with pegylated
interferon alfa-2a and other interferons. Coadministration
of TYZEKA with pegylated interferon alfa-2a
may increase the risk and severity of peripheral
neuropathy. The safety and efficacy of telbivudine
in combination with pegylated interferons or
other interferons for the treatment of chronic
hepatitis B has not been demonstrated. TYZEKA
therapy should be interrupted if peripheral
neuropathy is suspected and discontinued if
peripheral neuropathy is confirmed
Because TYZEKA is eliminated primarily by renal
excretion, coadministration of TYZEKA with drugs
that affect renal function may alter plasma
concentrations of TYZEKA and/or the coadministered
drug. Dose adjustment is required in patients
with creatinine clearance <50 mL/min, including
those with end stage renal disease (ESRD) on
hemodialysis. TYZEKA should be administered
after hemodialysis
Safety and effectiveness of TYZEKA in pediatric
patients under the age of 16 years have not
been established
Most common adverse events (=5%) in the GLOBE
and NV-02B-015 trials, regardless of attributability
to TYZEKA, were fatigue (13%), increased creatine
kinase (CK) [11%], headache (10%), cough (6%),
diarrhea (6%), upper abdominal pain (6%), nausea
(5%), and pharyngolaryngeal pain (5%)
Peripheral neuropathy was reported as an adverse
event in <1% (2/847) of subjects receiving
TYZEKA monotherapy. Of TYZEKA-treated subjects
<1% (5/847) were diagnosed with myopathy/myositis
(presenting with muscular weakness)
Creatine kinase (CK) elevations were more frequent
among subjects on TYZEKA treatment. Grade 3
or 4 CK elevations occurred in 13% of patients
treated with TYZEKA
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