Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer.
The recommended dose of Letrozole is 2.5 mg once daily. No dose adjustment is required for elderly patients.
In patients with advanced or metastatic breast cancer, treatment with Letrozole 2.5 mg Film-coated tablets should continue until tumour progression is evident.
In the adjuvant and extended adjuvant setting, treatment with Letrozole 2.5 mg Film-coated tablets should continue for 5 years or until tumour relapse occurs, whichever is first.
In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered (see sections 4.4 and 5.1). In the neoadjuvant setting, treatment with Letrozole 2.5 mg Film-coated tablets could be continued for 4 to 8 months in order to establish optimal tumour reduction. If the response is not adequate, treatment with Letrozole 2.5 mg Film-coated tablets should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
Letrozole 2.5 mg Film-coated tablets is not recommended for use in children and adolescents. The safety and efficacy of Letrozole 2.5 mg Film-coated tablets 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.
No dosage adjustment of Letrozole 2.5 mg Film-coated tablets is required for patients with renal insufficiency with creatinine clearance≥10 ml/min. Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min (see sections 4.4 and 5.2).
No dose adjustment of Letrozole 2.5 mg Film-coated tablets 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 C) require close supervision (see sections 4.4 and 5.2).
Letrozole 2.5 mg Film-coated tablets should be taken orally and can be taken with or without food.
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.
Shelf life: 36 months.
This medicinal product does not require any special storage conditions.
Aluminium/Aluminium blister packs and PVC/PE/PVDC/aluminium blister packs.
Pack sizes: 10, 14, 28, 30, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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