Arimidex 1mg x 30tabs

Each film-coated tablet contains 1 mg anastrozole.

Excipients with known effect

Each film-coated tablet contains 93 mg of lactose monohydrate (see section 4.4).

For the full list of excipients, see section 6.1.

Film-coated tablet.

White, round, biconvex film-coated tablets of about 6.1 mm marked with ‘A’ on one side and ‘Adx1’ on the other side.

Arimidex is indicated for the:

• Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.

• 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.

Posology

The recommended dose of Arimidex for adults including the elderly is one 1 mg tablet once a day.

For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.

Special populations

Pediatric population

Arimidex is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).

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 (see sections 4.4 and 5.2).

Hepatic impairment

No dose change is recommended in patients with mild hepatic disease. Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).

Method of administration

Arimidex should be taken orally.

Arimidex is contraindicated in:

• Pregnant or breastfeeding women.

• Patients with known hypersensitivity to anastrozole or to any of the excipients listed in section 6.1.

General

Arimidex should not be used in premenopausal women. 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 analogs.

Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see sections 4.5 and 5.1).

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 (see section 4.8).

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 (see section 4.8).

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 (see section 5.2); administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2). 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, see section 5.2); in patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2).

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 (see section 5.1).

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 (see section 5.1). 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, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 the 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 (see section 5.1).

Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.4 and 5.1).

Pregnancy

There are no data from the use of Arimidex in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Arimidex is contraindicated during pregnancy (see section 4.3).

Breastfeeding

There are no data on the use of Arimidex during lactation. Arimidex is contraindicated during breastfeeding (see section 4.3).

Fertility

The effects of Arimidex on fertility in humans have not been studied. Studies in animals have shown reproductive toxicity (see section 5.3).

Arimidex has no or negligible influence on the ability to drive and use machines. However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving or operating machinery while such symptoms persist.

The following table presents adverse reactions from clinical trials, post-marketing studies, or spontaneous reports. Unless specified, the frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer given adjuvant treatment for five years (the Arimidex, Tamoxifen, Alone or in Combination [ATAC] study).

Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), and very rare (<1/10,000). The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.