Telbivudine Disease Interactions

Prolonged use of certain nucleoside reverse transcriptase inhibitors (NRTIs) such as zidovudine and telbivudine may commonly cause myopathy, including rare cases of rhabdomyolysis. The myopathy may be dose-related and is characterized by persistent, unexplained muscle aches and/or weakness in conjunction with increases in creatine phosphokinase (CPK) values. Therapy with these NRTIs should be administered cautiously in patients with preexisting myopathy or a myoneural disorder, since it may delay the recognition or confound the diagnosis of a drug-induced musculoskeletal effect. Patients should be advised to report promptly any unusual muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. NRTI therapy should be interrupted if drug-related myopathy is suspected, and discontinued if myopathy is diagnosed.

Telbivudine is removed by hemodialysis. Up to four hours of hemodialysis can reduce systemic telbivudine exposure by approximately 23%. Telbivudine should be administered after hemodialysis. Following dose interval adjustment for creatinine clearance, no additional dose modification is necessary during routine hemodialysis.

Telbivudine is primarily eliminated by the kidney. Compared to patients with normal renal function (CrCl above 80 mL/min), systemic exposure (AUC) of single-dose telbivudine increased by 26% in patients with moderate renal dysfunction (CrCl 30 to 49 mL/min) and 136% in patients with end-stage renal disease managed on hemodialysis. Renal clearance decreased by 66% and 91%, respectively, in patients with moderate and severe renal dysfunction (CrCl below 30 mL/min). Adjustment of the dosing interval is recommended for patients with CrCl below 50 mL/min, including patients on dialysis, in accordance with the manufacturer's product labeling.