Presentation and Status in Health Basket
Film Coated Tablets
28 X 1 mg
Adults including the elderly: One 1 mg tablet to be taken orally once a day.
Children: Not recommended for use in children.
Renal Impairment: No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic Impairment: No dose change is recommended in patients with mild hepatic disease. For early disease, the recommended duration of treatment should be 5 years.
Treatment of advanced breast cancer in post-menopausal women. Efficacy has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. Adjuvant treatment of post-menopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive post-menopausal women who have received 2-3 years of adjuvant tamofen.
Pre-menopausal women. Pregnant or lactating women. Patients with severe renal impairment (creatinine clearance less than 20ml/min). Patients with moderate or severe hepatic disease. Patients with known hypersensitivity to anastrozole or to any of the excipients. Co-administration of tamoxifen or oestrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see Interactions with other medicinal products and other forms of interaction.
General: Arimidex 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 patient where there is doubt about menopausal status. There are no data to support the use of Arimidex with LHRH analogues. Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action.
Effect on bone mineral density: As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture. 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 Arimidex in postmenopausal women and could be considered.
Hepatic impairment: Arimidex 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; administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution. Treatment should be based on a benefit-risk evaluation for the individual patient.
Renal impairment: Arimidex 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); in patients with severe renal impairment, administration of Arimidex should be performed with caution.
Ischemic Cardiovascular Events: In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with this product in the ATAC trial (17% of patients on this product and 10% of patients on tamoxifen). Consider risk and benefits of therapy in patients with pre-existing ischemic heart disease.
Cholesterol: During the ATAC trial, more patients receiving this product were reported to have elevated serum cholesterol compared to patients receiving tamoxifen.
Paediatric population: Arimidex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients. Arimidex 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. Since anastrozole reduces estradiol levels, Arimidex 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. 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.
For full details see prescribing information.
Very common: (10%) Vascular: Hot flushes, mainly mild or moderate in nature. General Asthenia, mainly mild or moderate in nature Musculoskeletal and connective tissue disorders Arthralgia/Joint stiffness Arthritis Osteoporosis Nervous system Headache, mainly mild or moderate in nature Gastrointestinal Nausea, mainly mild or moderate in nature Skin and subcutaneous tissue disorders.
Common: ( 1% and < 10%) Musculoskeletal, connective tissue disorders and bone Bone pain back pain, Myalgia Reproductive system and breast: Vaginal dryness, mainly mild or moderate in nature. Vaginal bleeding, mainly mild or moderate in nature* Skin and subcutaneous tissue disordres: Hair thinning (Alopecia), mainly mild or moderate in nature. Allergic reactions Gastrointestinal: Diarrhoea, mainly mild or moderate in nature. Vomiting, mainly mild or moderate in nature Nervous system: Somnolence, mainly mild or moderate in nature. Depression Carpal Tunnel Syndrome**. Sensory disturbances (including paraesthesia, taste loss and taste perversion) Hepatobiliary disorders Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Metabolism and nutrition Anorexia, mainly mild in nature Hypercholesterolaemia, mainly mild or moderate in nature Respiratory Pharyngitis, Increased cough, Dyspnea, and lymphedema. Vascular hypertension insomnia increased cough.
For full details see prescribing information.
Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro. Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R– and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes. The enzymes mediating metabolism of anastrozole have not been identified. Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole. The effect of potent CYP inhibitors is unknown. A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with this product who also received other commonly prescribed drugs. There were no clinically significant interactions with bisphosphonates. Co-administration of tamoxifen or oestrogen-containing therapies with Armidex should be avoided as this may diminish its pharmacological action.
Pregnancy and Lactation
This produt is contraindicated in pregnant or lactating women.
There is limited clinical experience of accidental overdose. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of this product that results in life-threatening symptoms has not been established. There is no specific antidote to overdose and treatment must be symptomatic. In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because this product is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.