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ARIMIDEX (anastrozole) prescribing and dosage information
For full detailed regulatory information about ARIMIDEX, including a description of the ingredients in ARIMIDEX tablets, the ARIMIDEX dosage and ARIMIDEX safety and efficacy, please see the ARIMIDEX UK Summary of Product Characteristics (SmPC). As prescribing information may vary from country to country, please see the local ARIMIDEX prescribing information for country-specific details.
Abbreviated Summary of Product Characteristics (SmPC)
Name of the medicinal product1
ARIMIDEX 1-mg film-coated tablets.
Qualitative and quantitative composition1
Each ARIMIDEX tablet contains 1 mg of anastrozole.
Pharmaceutical form1
Film-coated, white, round, biconvex tablet with logo on one side and dosage strength on the other.
Therapeutic indications1
- Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women.
- Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
- Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
Posology and method of administration1
Adults including the elderly, one 1 mg tablet orally once a day.
Postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.
Paediatric population: not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Renal impairment: No dose change is recommended in patients with mild or moderate renal impairment. In patients with severe renal impairment, administration of Arimidex should be performed with caution.
Hepatic impairment: No dose change is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment.
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
Contraindications1
- Pregnant or breast-feeding women.
- Patients with known hypersensitivity to anastrozole or to any of the excipients.
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
Interaction with other medicinal products and other forms of interaction1
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 Arimidex who also received other commonly prescribed medicinal products. There were no clinically significant interactions with bisphosphonates. Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action.
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
ARIMIDEX (anastrozole) side effects1
To date it is estimated that total ARIMIDEX patient exposure equates to over 5.9 million patient-years.2 ARIMIDEX is generally well tolerated. The ARIMIDEX UK Summary of Product Characteristics (SmPC) details the side effects of ARIMIDEX, the majority of information being derived from the ATAC trial.1
The most frequently reported adverse reactions (with a frequency of ≥10%) are1: Headache, Hot Flushes, Nausea, Rash, Arthralgia/joint stiffness, Arthritis, Osteoporosis, Asthenia.
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
Please refer to your local SmPC for full details of safety and tolerability.
References
- ARIMIDEX UK SmPC. Last updated 7th Oct 2011. http://www.medicines.org.uk/emc/medicine/3845/SPC/Arimidex+1mg+Film-Coated+Tablet/
As there may be local variations in the approved label, please consult the local ARIMIDEX prescribing information before use.
- AstraZeneca, Data on file; ADX2810102.
