Zeffix Dosage/Direction for Use

The recommended dosage of ZEFFIX is 100 mg once daily. ZEFFIX can be taken with or without food.
Patient compliance should be monitored while on ZEFFIX therapy.
Discontinuation of ZEFFIX may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occurs. Discontinuation may also be considered when loss of efficacy occurs, as indicated by recurrent signs of hepatitis.
If ZEFFIX is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see Precautions).
Discontinuation of treatment is not recommended in patients with decompensated liver disease. There are limited data regarding the maintenance of seroconversion long term after stopping treatment with ZEFFIX.
ZEFFIX should be used in accordance with available official recommendations.
Populations: Renal impairment: Lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance. The dosage should therefore be reduced for patients with a creatinine clearance of less than 50 ml/min.
Data available in patients undergoing intermittent haemodialysis (less than or equal to 4 hours dialysis 2 to 3 times weekly), indicate that following the initial dosage reduction of ZEFFIX to correct for the patient's creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
Hepatic impairment: Data obtained in patients with hepatic impairment, including those with end-stage liver disease awaiting transplant, show that ZEFFIX pharmacokinetics are not significantly affected by hepatic dysfunction.
Based on these data, no dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment.