Indication

Feremazol is indicated for:

• Adjuvant treatment of postmenopausal women with early-stage, hormone receptor-positive invasive breast cancer.
• Extended adjuvant treatment of postmenopausal women with early-stage, hormone receptor-positive invasive breast cancer who have previously received standard adjuvant treatment with tamoxifen for 5 years.
• First-line treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
• Treatment of advanced or recurrent breast cancer in postmenopausal women, either naturally or artificially induced, who have previously been treated with anti-estrogens.
• Neoadjuvant (pre-operative) treatment of postmenopausal women with hormone receptor-positive, HER2-negative breast cancer, when chemotherapy is not suitable and immediate surgery is not indicated.

Dosage and Method of Administration

Adults

The recommended dose of Feremazol is 2.5 mg once daily.

During adjuvant and extended adjuvant treatment, treatment with Feremazol should be continued for 5 years or until disease recurrence occurs.

In the adjuvant setting, the option of sequential treatment should also be considered (letrozole for 2 years followed by tamoxifen for 3 years).

In patients with metastatic disease, treatment with Feremazol should be continued until signs of disease progression appear.

During neoadjuvant (pre-operative) treatment, Feremazol is recommended for 4–8 months to achieve optimal tumor reduction. If the response is inadequate, treatment should be discontinued, surgery should be considered, and/or further treatment options should be discussed with the patient.

Patients with Hepatic Impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).

There are insufficient data in patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh Class C) should be kept under close medical supervision.

Patients with Renal Impairment

No dose adjustment is required in patients with mild or moderate renal impairment (creatinine clearance ≥10 mL/min).

There are insufficient data in patients with creatinine clearance <10 mL/min.

Pediatric Population

The safety and efficacy of letrozole in children and adolescents up to 18 years of age have not been established. The use of Feremazol in children and adolescents is not recommended.

Elderly Patients

No dose adjustment is required in elderly patients.

Oral Administration

Feremazol is administered orally. It may be taken with or without food, as food does not affect the absorption of the medicine.

If a dose is missed, the patient should take it as soon as she remembers. However, if the missed dose is remembered shortly before the next scheduled dose (within 2–3 hours), the missed dose should be skipped and the next dose taken according to the regular schedule.

It is not recommended to exceed the daily dose of 2.5 mg.

Packaging

10 tablets in a PVC/PVdC-coated and aluminum-foil blister pack.

Three blister packs, together with the package leaflet, are packaged in a cardboard box.

Storage Conditions

Store at a temperature not exceeding 25°C.

Keep in the original packaging to protect from moisture.

Keep out of the reach of children.

Shelf Life

2 years.

Do not use after the expiry date.

Prescription status

Prescription only.

Manufacturer 

Remedica Ltd., Cyprus

Aharnon Street, Limassol Industrial Estate,
3056 Limassol, Cyprus.