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