Anastrozole 1 Eurodrug Special Precautions

General: Anastrozole should not be used in premenopausal women. The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patients where there is doubt about menopausal status. There are no data to support the use of anastrozole with LHRH analogues.
Co-administration of tamoxifen or estrogen-containing therapies with anastrozole should be avoided as this may diminish its pharmacological action (see Interactions and PHARMACOLOGY: Pharmacodynamics under Actions).
Effect on bone mineral density: As anastrozole lowers circulating estrogen levels it may cause reduction in bone mineral density with a possible consequent increased risk of fracture (see Adverse Reactions).
Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored. The use of specific treatments, e.g., bisphosphonates may stop further bone mineral loss caused by anastrozole in postmenopausal women and could be considered (see Adverse Reactions).
Hepatic impairment: Anastrozole has not been investigated in breast cancer patients with moderate or severe hepatic impairment. Exposure to anastrozole can be increased in subjects with hepatic impairment (see PHARMACOLOGY: Pharmacokinetics under Actions); administration of anastrozole in patients with moderate and severe hepatic impairment should be performed with caution (see Dosage & Administration). Treatment should be based on a benefit-risk evaluation for the individual patient.
Renal impairment: Anastrozole has not been investigated in breast cancer patients with severe renal impairment. Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min, see PHARMACOLOGY: Pharmacokinetics under Actions); in patients with severe renal impairment, administration of anastrozole should be performed with caution (see Dosage & Administration).
Hypersensitivity to lactose: This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: 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.
Use in Children: Anastrozole is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see PHARMACOLOGY: Pharmacodynamics under Actions).
Anastrozole should not be used in boys with growth hormone deficiency in addition to growth hormone treatment. In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see PHARMACOLOGY: Pharmacodynamics under Actions). Since anastrozole reduces estradiol levels, anastrozole must not be used in girls with growth hormone deficiency in addition to growth hormone treatment. Long-term safety data in children and adolescents are not available.