LEZRA TABLET 2.5MG

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**DOSAGE AND ADMINISTRATION** **Adults** The recommended dose of Lezra is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Lezra should continue for 5 years or until disease relapse/recurrence occurs, whichever comes first. In patients with metastatic disease, treatment with Lezra should continue until tumor progression is evident. **Special populations** **Hepatic impairment** No dose adjustment of Lezra is required for patients with mild to moderate hepatic insufficiency (Child-Pugh score A or B). Insufficient data are available for patients with severe hepatic impairment, but patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision (see sections WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dosage adjustment of Lezra is required for patients with renal insufficiency with creatinine clearance (CLcr) ≥10 mL/min. Insufficient data are available in cases of renal insufficiency with CLcr <10 mL/min (see sections WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatrics** Lezra is not recommended for use in children and adolescents. The safety and efficacy of Lezra in children and adolescents aged up to 17 years have not been established. Limited data are available and no recommendation on a posology can be made. **Geriatric patients (65 years of age or older)** No dose adjustment is required for elderly patients. **Method of administration** Lezra should be taken orally and can be taken with or without food because food has no effect on the extent of absorption. **Missed dose** The missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose, the missed dose should be skipped, and the patient should go back to her regular dosage schedule. Doses should not be doubled because with daily doses over the 2.5 mg recommended dose, over-proportionality in systemic exposure was observed (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).