ARIMIDEX (Anastrozole)

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28 Tablets
Strength :
1 mg

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Arimidex has pioneered new standards in the hormonal treatment of breast cancer in postmenopausal women and is currently the world’s leading aromatase inhibitor, with well over 1 million patient years’ experience.

Mature (long-term) data from the ATAC trial reveals a new standard of care for early breast cancer.

Definitive data from the ATAC Completed Treatment Analysis with over 68 months follow up now confirm that 5 years primary adjuvant therapy with Arimidex, rather than tamoxifen demonstrates:

Superior efficacy

Increasing efficacy benefits beyond 5 years
Trend for reduction in breast cancer mortality
Superior tolerability

Completed 5-year tolerability profile superior to tamoxifen
Known, predictable and manageable safety profile
Arimidex is now established as a more effective and better tolerated treatment than tamoxifen in the primary adjuvant therapy of postmenopausal women with hormone-sensitive early breast cancer, given for the first 5 years following surgery when the risk of recurrence is at its highest.

Arimidex is a proven first-line choice for postmenopausal women with advanced breast cancer:

Significant efficacy and tolerability benefits over tamoxifen
Tamoxifen can produce a clinical benefit following Arimidex
Arimidex is the only aromatase inhibitor with mature survival benefit over megestrol acetate

Arimidex is the most selective aromatase inhibitor:

Free from significant effects on adrenal function
No clinically significant effect on lipids
No androgenic effect
Arimidex™ (anastrozole) prescribing information
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Warnings and Precautions
Undesirable effects

This text is based on the European Union Summary of Product Characteristics. The indications for Arimidex™ may vary between countries, please consult your local product information before prescribing

Arimidex™, 1 mg, tablets
Arimidex is a trade mark, property of the AstraZeneca group.

Abbreviated Prescribing Information:
See local Prescribing Information for full details, as Prescribing Information may vary from country to country.

1. Treatment of advanced breast cancer in postmenopausal women.

2. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer*.

* Quoted from the US Prescribing Information, approved September 2002.

Dosage: Adults including elderly: 1 mg to be taken orally once a day. No change in dose is recommended in renal or hepatic impairment. Children:Not recommended.

Contra-indications: Arimidex must not be administered during pregnancy or lactation. Known hypersensitivity to the active substance or to any of the excipients of this product.

Warnings and Precautions: Arimidex is not recommended for use in children or pre-menopausal women. Arimidex has not been investigated in patients with severe hepatic or severe renal impairment. Asthenia and somnolence have been reported with use of Arimidex, and caution should be observed when driving or operating machinery while such symptoms persist.

Interactions: Tamoxifen and/or oestrogen containing therapies should not be co-administered, as they would diminish the pharmacological action of Arimidex.

Undesirable effects

Frequency System Organ Class Adverse Reaction
Very common (≥ 10%) Vascular: Hot flushes, mainly mild or moderate in nature.
(≥1-10%) General: Asthenia, mainly mild or moderate in nature.
Musculoskeletal, connective tissue and bone: Joint pain/stiffness, mainly mild or moderate in nature.
Reproductive system and breast: Vaginal dryness, mainly mild or moderate in nature.
Skin and subcutaneous tissue: Hair thinning, mainly mild or moderate in nature.
Rash, mainly mild or moderate in nature.
Gastrointestinal: Nausea, mainly mild or moderate in nature.
Diarrhoea, mainly mild or moderate in nature.
Nervous system: Headache, mainly mild or moderate in nature.
Uncommon (≥0.1-1%) Reproductive system and breast: Vaginal bleeding, mainly mild or moderate in nature*.
Metabolism and nutrition: Anorexia, mainly mild in nature.
Hypercholesterolemia, mainly mild or moderate in nature.
Gastrointestinal: Vomiting, mainly mild or moderate in nature.

Nervous system: Somnolence, mainly mild or moderate in nature.
Very rare ( Stevens-Johnson syndrome.

Vaginal bleeding has been reported uncommonly, mainly in patients with advanced breast cancer. Elevated gamma-GT and alkaline phosphatase have been reported uncommonly, but a causal relationship has not been established.

Presentation: Tablets containing 1 mg anastrozole.

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