Adjuvant therapy for hormone-positive breast cancer in early stages in postmenopausal women. Extended adjuvant therapy for early-stage breast cancer in postmenopausal women who received standard adjuvant therapy with tamoxifen. Treatment of common forms of breast cancer in postmenopausal women as a first-line drug.
Letrozol №100 Composition
active substance: letrozole;
1 tablet contains letrozole 2.5 mg
excipients: lactose monohydrate, corn starch sodium starch (type A); microcrystalline cellulose magnesium stearate shell Opadray II 85F32410 yellow: polyvinyl alcohol; macrogol 3350; talc titanium dioxide (E 171) iron oxide yellow (E 172).
Letrozol №100 Indications.
Adjuvant therapy for hormone-positive invasive breast cancer in early stages in postmenopausal women.
Expanded adjuvant therapy for early invasive breast cancer in postmenopausal women who have received standard adjuvant tamoxifen therapy for 5 years.
First-line therapy for hormone-dependent advanced breast cancer in postmenopausal women.
Treatment of common forms of breast cancer in postmenopausal women (natural or artificial) after relapse or progression of the disease, who received prior antiestrogen therapy.
Neoadjuvant therapy in postmenopausal women with hormone-positive, HER-2-negative breast cancer who are unsuitable for chemotherapy and are not indicated for urgent surgery.
The effectiveness of the drug for patients with hormone-negative breast cancer has not been proven.
Letrozol №100 Contraindications
– hypersensitivity to the active substance or to any of the excipients.
– premenopausal endocrine status.
– the reproductive age of the patient.
Letrozol №100 Method of administration and dosage.
Adults, including elderly patients. The recommended dose of letrozole is 2.5 mg once a day.
In the setting of adjuvant and extended adjuvant therapy, letrozole treatment should be continued for 5 years or until tumor recurrence, whichever comes first.
In patients with metastatic breast cancer or advanced breast cancer, letrozole treatment should be continued until signs of tumor progression appear.
In the setting of adjuvant therapy, a sequential treatment regimen should also be considered (letrozole for 2 years, then tamoxifen for 3 years).
In the setting of neoadjuvant therapy, letrozole treatment should be continued for 4 to 8 months in order to establish optimal tumor shrinkage. If the response to treatment is not sufficient, treatment with letrozole should be discontinued and surgery and / or other treatment options should be planned and discussed with the patient.
For elderly patients, dose adjustment of the drug is not needed.
Mode of application
Letrozole-Vista should be taken orally, regardless of food intake, since food does not affect the degree of absorption.
The missed dose should be taken as soon as the patient remembers it. However, if the patient remembers this shortly before taking the next dose (2-3 hours), the missed dose should be taken and the next dose should be taken according to the schedule. Do not take a double dose, because when taking a daily dose higher than the recommended 2.5 mg, a systemic exposure higher than the proportional one was observed.
The drug is not intended for use in children. The safety and efficacy of Letrozole-Vista treatment in children (under the age of 18) have not been established. The available data are limited, so it is not possible to develop a dosing recommendation.