Etruzil (letrozole) coated tablets 2.5 mg. №30


Manufacturer: Hungary

Adjuvant therapy for hormone-positive invasive breast cancer in early stages in postmenopausal women. Extended adjuvant therapy for early-stage invasive breast cancer in postmenopausal women who received standard adjuvant therapy with tamoxifen for 5 yEars and Nose. First-line therapy for hormone-dependent advanced breast cancer in postmenopausal women. Treatment of common forms of breast cancer in postmenopausal women (natural or artificially induced) after a relapse or progression of the disease, who received previous antiestrogen therapy. Neoadjuvant therapy in postmenopausal women with hormone-positive, HER2-negative breast cancer who are not suitable for chemotherapy and do not need emergency surgery. The effectiveness of the drug for patients with hormone-negative breast cancer has not been proven.



Etruzil Composition
The active ingredient is letrozole (one coated tablet contains 2.5 mg letrozole).

Excipients: lactose, monohydrate; microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silicon dioxide, hypromellose, talc, macrogol 8000, titanium dioxide (E171), iron oxide yellow (172).

Etruzil Contraindications
hypersensitivity to letrozole or to any excipients of the drug;
endocrine premenopausal status, pregnancy, lactation period;
severe liver failure;
preoperative use of the drug if the status of the receptors is negative or unknown;
women of reproductive age.

Mode of application
Adults, including elderly patients
The recommended dose of Etruzil is 2.5 mg once a day. In adjuvant and extended adjuvant therapy, treatment with Etrusil should be continued for 5 years or until a relapse occurs. Patients with metastases should be treated with Etruzil until signs of disease progression become evident. In the context of adjuvant treatment, the possibility of using a sequential therapy regimen (letrozole for 2 years, followed by a switch to tamoxifen for 3 years) should also be considered.

In neoadjuvant conditions, therapy with Etrusil should be continued for 4-8 months in order to achieve optimal tumor shrinkage. If the response to treatment is insufficient, therapy with Etruzil should be discontinued and planned surgery should be prescribed and / or further treatment options should be discussed with the patient.

For elderly patients, dose adjustment is not required.

Etruzil Method of use
The drug “Etrusil” 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 skipped 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.

Application features
The drug should not be used in children, since the efficacy and safety of letrozole for this category of patients has not been studied in clinical trials.

The influence of the drug “Etruzil” on the ability to drive vehicles and work with mechanisms is insignificant. Since during the treatment with the drug, patients experienced general weakness and dizziness, as well as in some cases – drowsiness, caution is recommended when driving or working with complex mechanisms.

Reported isolated cases of overdose with letrozole.

The specific treatment for overdose is unknown; treatment should be symptomatic and supportive.