Letrozole STELLA 2.5 mg

Rx

Indications

• Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.
• Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
• First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
• Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
• Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
• Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer.

Dosage

• Recommended dose: 2.5 mg once daily.
• No dose adjustment is required for elderly patients.
• In patients with advanced or metastatic breast cancer, treatment with Letrozole STELLA 2.5 mg should continue until tumour progression is evident.
• In the adjuvant and extended adjuvant setting, treatment with Letrozole STELLA 2.5 mg should continue for 5 years or until tumour relapse occurs, whichever is first.
• In the adjuvant setting, a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered.
• In the neoadjuvant setting, treatment with Letrozole STELLA 2.5 mg could be continued for 4 to 8 months in order to establish optimal tumour reduction. If the response is not adequate, treatment with Letrozole STELLA 2.5 mg should be discontinued and surgery scheduled and/or further treatment options discussed with the patient.
• Letrozole STELLA 2.5 mg is not recommended for use in children and adolescents.
• No dosage adjustment of Letrozole STELLA 2.5 mg is required for patients with renal insufficiency with creatinine clearance ≥ 10 mL/min. Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 mL/min.
• No dose adjustment of Letrozole STELLA 2.5 mg is required for patients with mild to moderate hepatic insufficiency (Child-Pugh A or B). Insufficient data are available for patients with severe hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) require close supervision.

Usage

• Letrozole STELLA 2.5 mg should be taken orally and can be taken with or without food.
• A missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose (within 2 or 3 hours), the missed dose should be skipped, and the patient should go back to her regular dosage schedule.
• Doses should not be doubled because with daily doses over the 2.5 mg recommended dose, over-proportionality in systemic exposure was observed.

• Hypersensitivity to letrozole or to any of the excipients of the drug,
• Premenopausal endocrine status,
• Pregnancy,
• Breast-feeding

Very common

• Hypercholesterolaemia,
• Hot flushes,
• Hyperhidrosis,
• Arthralgia,
• Fatigue (including asthenia, malaise).

Common

• Decreased appetite, increased appetite,
• Depression,
• Headache, dizziness,
• Palpitations,
• Hypertension,
• Nausea, dyspepsia1, constipation, abdominal pain, diarrhoea, vomiting,
• Alopecia, rash (including erythematous, maculopapular, psoriaform, and vesicular rash), dry skin,
• Myalgia, bone pain1, osteoporosis, bone fractures, arthritis,
• Vaginal haemorrhage,
• Peripheral oedema, chest pain,
• Weight increased.

• Only women of postmenopausal endocrine status should receive Letrozole STELLA 2.5 mg.
• The potential risk/benefit to patients in renal impairment should be carefully considered before administration of Letrozole STELLA 2.5 mg.
• Patients with severe hepatic impairment (Child-Pugh C), should therefore be kept under close supervision.
• Letrozole STELLA 2.5 mg is a potent oestrogen-lowering agent. Women with a history of osteoporosis and/or fractures, or who are at increased risk of osteoporosis, should have their bone mineral density formally assessed prior to the commencement of adjuvant and extended adjuvant treatment and monitored during and following treatment with letrozole. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. In the adjuvant setting, a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered depending on the patient’s safety profile.
• Tendonitis and tendon ruptures (rare) may occur. Close monitoring of the patients and appropriate measures (e.g. immobilisation) must be initiated for the affected tendon.
• Co-administration of Letrozole STELLA 2.5 mg with tamoxifen, other anti-oestrogens or oestrogen-containing therapies should be avoided as these substances may diminish the pharmacological action of letrozole.
• Letrozole STELLA 2.5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Letrozole STELLA 2.5 mg should only be used in women with a clearly established postmenopausal status. As there are reports of women regaining ovarian function during treatment with letrozole despite a clear postmenopausal status at start of therapy, the physician needs to discuss adequate contraception when necessary.
• Letrozole STELLA 2.5 mg is contraindicated during pregnancy and breast-feeding.
• Letrozole has minor influence on the ability to drive and use machines. Since fatigue and dizziness have been observed with the use of letrozole and somnolence has been reported uncommonly, caution is advised when driving or using machines.