Letrozole

Aralet film-coated tablets are indicated for:

• Adjuvant therapy of hormone-positive invasive breast cancer in the early stages in postmenopausal women.
• Expanded adjuvant therapy of invasive breast cancer in the early stages of postmenopausal women who underwent standard adjuvant therapy with tamoxifen 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 artificially induced) after relapse or disease progression who have received prior antiestrogen therapy.
• Neoadjuvant therapy in postmenopausal women with hormone-positive, HER-2-negative breast cancer, which is not suitable for chemotherapy and is not indicated for emergency surgery.

Structure

Active ingredient: letrozole;

1 coated tablet contains letrozole - 2.5 mg;

Excipients: lactose monohydrate, microcrystalline cellulose, starch, corn starch, sodium starch (type A); silicon dioxide colloidal magnesium stearate

Film sheath: Opadry yellow 02B38014: hypromellose (E 464), iron oxide red (E 172), iron oxide yellow (E 172), talc, macrogol, titanium dioxide (E 171).

Contraindications

• Hypersensitivity to the active substance or to any other component of the drug.
• Endocrine status characteristic of the premenopausal period.
• Pregnancy, lactation period.
• Women of reproductive age.

Mode of application

Aralet 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 this. 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. A double dose should not be taken, since when taking a daily dose higher than the recommended 2.5 mg, a systemic exposure was observed that was higher than proportional.

Application features

Pregnant women

Not applicable.

Children

Not applicable.

Drivers

The effect of letrozole on the ability to drive vehicles and work with mechanisms is negligible. Since during treatment with the drug, patients showed general weakness and dizziness, in some cases drowsiness, patients should be warned that, if these symptoms occur, you should refuse to drive vehicles or work with mechanisms.

Overdose

Isolated cases of an overdose of the drug Aralet have been reported.

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

Side effects

Fatigue (including asthenia, malaise), peripheral edema, chest pain, fever, dry mucous membranes, thirst, generalized edema.

Interaction

Inhibitors of the activity of CYP3A4 and CYP2A6 can reduce the metabolism of letrozole and, thus, increase the concentration of letrozole in blood plasma. The simultaneous use of drugs that strongly inhibit these enzymes (potent CYP3A4 inhibitors include, but are not limited to: ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin; CYP2A6 (e.g., methoxalen)) can increase the exposure of letrozole. Therefore, patients who are shown potent inhibitors of CYP3A4 and CYP2A6 are advised to exercise caution in their use.

Storage conditions

It does not require special storage conditions.

Keep out of the reach of children.

Shelf life is 5 years.