Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND www.viatris.co.nz Telephone 0800 168 169
The recommended dose of Letrole is 2.5 mg once daily.
In the adjuvant and extended adjuvant setting, treatment with Letrole should continue for 5 years or until tumour relapse occurs, whichever comes first.
In patients with metastatic disease, treatment with Letrole should continue until tumour progression is evident.
No dose adjustment is required for elderly patients.
No dosage adjustment is required for patients with renal impairment (creatinine clearance ≥10 mL/min.). Insufficient data are available to justify a dose advice in cases of renal insufficiency with a creatinine clearance less than 10 mL/min or in patients (see section 4.4 and 5.2).
No dose adjustment of letrozole is required for patients with mild to moderate hepatic insufficiency (Child-Pugh A or B). Insufficient data are available for patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh score C) should be kept under close supervision (see section 4.4 and 5.2).
Letrole is not recommended for use in children and adolescents. The safety and efficacy of Letrole 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.
Tablets to be swallowed whole. Do not halve the tablet. Dose equivalence when the tablet is divided has not been established.
A missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose (within 2 or 3 hours), 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 5.2).
Isolated cases of overdose with letrozole have been reported.
No specific treatment for overdose is known. Treatment should be symptomatic and supportive.
For further advice on management of overdose please contact the National Poisons Information Centre (0800 POISON or 0800 764 766).
3 years.
Store at or below 25°C.
PVC/PVdC/Aluminium blister. Pack size of 30 film-coated tablets.
No special requirements for disposal.
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