Anastrozole STELLA 1 mg

Rx

Indications

• Adjuvant treatment of early breast cancer: Used for postmenopausal women with hormone receptor-positive early breast cancer.
• Advanced breast cancer: Used for advanced or metastatic breast cancer in postmenopausal women, including those who have continued to have breast cancer after taking Tamoxifen.
• Primary prevention of breast cancer in postmenopausal women at intermediate or high risk.

Dosage

• Recommended dose for adults including the elderly: One 1 mg tablet once a day.
• No dose change is recommended in patients with mild or moderate renal and hepatic impairment.
• In patients with severe renal and hepatic impairment, administration of anastrozole should be performed with caution.

Usage

• Oral administration.

• Patients with known hypersensitivity to anastrozole or to any of the excipients of the drug.
• Pregnant or breastfeeding women.
• Children and adolescents.

Very common

• Depression,
• Headache,
• Hot flushes,
• Nausea,
• Rash,
• Arthralgia/joint stiffness, arthritis, osteoporosis,
• Asthenia.

Common

• Anorexia, hypercholesterolaemia,
• Somnolence, carpal tunnel syndrome, sensory disturbances (including paraesthesia, taste loss and taste perversion),
• Diarrhoea, vomiting,
• Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase,
• Hair thinning (alopecia), allergic reactions,
• Bone pain, myalgia,
• Vaginal dryness, vaginal bleeding.

• Anastrozole should not be used in premenopausal women.
• Co-administration of tamoxifen or estrogen-containing therapies with anastrozole should be avoided as this may diminish its pharmacological action.
• Cardiovascular risks must be considered when starting anastrozole for primary prevention in healthy individuals as well as a potential cause of new onset/deterioration of these conditions in those already receiving treatment with anastrozole.
• Patients with severe osteoporosis or more than two vertebral fractures are not suitable for anastrozole use in primary prevention of breast cancer.
• Administration of anastrozole in patients with moderate and severe hepatic impairment, severe renal impairment should be performed with caution.
• Anastrozole is not recommended for use in children and adolescents as safety and efficacy have not been established.
• Anastrozole is contraindicated during pregnancy and breastfeeding.
• Anastrozole has no or negligible influence on the ability to drive and use machines. However, asthenia and somnolence have been reported with the use of anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.