t treatment with these or other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. TYZEKA therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed. -- Because TYZEKA is eliminated primarily by renal excretion, co- administration of TYZEKA with drugs that affect renal function may alter plasma concentrations of TYZEKA and/or the coadministered drug. Dose interval adjustment is required in patients with creatinine clearance <50mL/min including those with end stage renal disease on hemodialysis. For patients on hemodialysis, telbivudine should be administered after hemodialysis. -- The safety and efficacy of TYZEKA in liver transplant recipients are unknown. If TYZEKA treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with TYZEKA. -- Patients should be advised that treatment with TYZEKA has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. -- Safety and effectiveness of TYZEKA in pediatric patients under the age of 16 years have not been established. -- Most common adverse events (>5%) in clinical studies, regardless of attributability to telbivudine, were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vo
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