Letrozol Labatec Filmtabletten 2.5mg 30 Stück

Description

Special instructions

Patients with severe hepatic dysfunction should be under continuous monitoring.

There are no data on the use of letrozole in patients with creatinine clearance less than 10 ml/min. Before starting the use of the drug in such patients, the ratio between the potential risk and expected effect of treatment should be carefully assessed.

Since the drug Letrozole is used only in postmenopausal patients, in case of unclear status of hormonal regulation of reproductive system it is recommended to determine the concentration of luteinising hormone (LH), follicle-stimulating hormone (FSH) and/or estradiol before treatment.

Increase of FSH level in serum leads to stimulation of follicle growth and may induce ovulation, in this regard, during the therapy with the drug, there is a potential possibility of pregnancy in perimenopausal and early postmenopausal women. In such cases, reliable contraceptive methods should be used until stable postmenopausal hormonal levels are established in this category of patients.

There are data on the development of osteoporosis and/or occurrence of bone fractures during the use of letrozole (see “Musculoskeletal and connective tissue adverse reactions”), therefore, careful monitoring of bone tissue condition during the whole period of drug administration is recommended.

It is recommended to avoid concomitant use of the drug with tamoxifen, other anti-estrogenic and estrogen-containing drugs, as these drugs may weaken the pharmacological effect of letrozole (see “Interaction with other medicinal products”). The mechanism of this interaction is not studied.

The drug is not indicated for therapy of breast cancer without receptors to steroid hormones (estrogen or progesterone).

Tendinitis and tendon rupture:

Tendon rupture may occur (with unknown frequency). Close monitoring of patients is required and appropriate measures (e.g. immobilisation) should be taken for the affected tendon.