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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
Articles on Tyzeka (telbivudine) for the Treatment of Hepatitis
B
How
Long Do Chronic Hepatitis B Patients Need to be Treated
to Sustain HBeAg Seroconversion?
6-25-2010
Telbivudine
(Tyzeka) Produces Better Outcomes than Lamivudine
in Hepatitis B Patients with Decompensated Cirrhosis
4-30-2010
Long-term
Data Show Telbivudine (Tyzeka)
Suppresses HBV Viral Load and Leads to HBeAg Clearance in
Chronic Hepatitis B Patients
11-20-2009
Predictors
of Good Response to Telbivudine (Tyzeka)
for Chronic Hepatitis B
8-04-2009
Telbivudine
(Tyzeka) Continues to Produce Good Results for
Chronic Hepatitis B Patients after 3 Years
5-08-2009
Telbivudine
(Tyzeka) May Be Effective for Chronic Hepatitis
B Treatment after Failure of Adefovir (Hepsera)
3-10-2009
GLOBE
Trial 2-Year Data Shows Telbivudine (Tyzeka) Is More Effective
than Lamivudine (Epivir-HBV)
for Chronic Hepatitis B
2-27-2009
Does
Telbivudine (Tyzeka) Have
Activity Against HIV?
2-17-2009
Canadian
Health Officials Warn against Use of Tebivudine
(Tyzeka/Sebivo) in Combination with Interferons
3-18-2009
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