Full Prescribing Information

ADVERSE REACTIONS

Adjuvant Treatment

Serious adverse reactions with anastrozole occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling.

Common adverse reactions (occurring with an incidence of >10%) in women taking anastrozole included: hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, pain, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema.

In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the anastrozole group.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

Body as a Whole: Flu syndrome; fever; neck pain; malaise; accidental injury; infection

Cardiovascular: Hypertension; thrombophlebitis

Hepatic: Gamma GT increased; SGOT increased; SGPT increased

Hematologic: Anemia; leukopenia

Metabolic and Nutritional: Alkaline phosphatase increased; weight loss

Mean serum total cholesterol levels increased by 0.5 mmol/L among patients receiving anastrozole. Increases in LDL cholesterol have been shown to contribute to these changes.

Musculoskeletal: Myalgia; arthralgia; pathological fracture

Nervous: Somnolence; confusion; insomnia; anxiety; nervousness

Respiratory: Sinusitis; bronchitis; rhinitis

Skin and Appendages: Hair thinning (alopecia); pruritus

Urogenital: Urinary tract infection; breast pain

Post-Marketing Experience

Hepatobiliary events including increases in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase have been reported (≤1% and <10%) and gamma-GT, bilirubin and hepatitis have been reported (≤0.1% and <1%) in patients receiving anastrozole.

Anastrozole may also be associated with rash including cases of mucocutaneous disorders such as erythema multiforme and Stevens-Johnson syndrome.

Cases of allergic reactions including angioedema, urticaria and anaphylaxis have been reported in patients receiving anastrozole.

Trigger finger has been reported (>0.1% and <1%) in patients receiving anastrozole.


VISION

At Taj Pharmaceuticals our goal is to create innovative drugs and diagnostic tools for the medicine of tomorrow. Rapid progress in the sciences is providing crucial insights into the underlying molecular mechanisms of disease, opening up new ways for prevention, diagnosis and therapy. With the expertise in Diagnostics and Pharmaceuticals, Taj Pharmaceuticals is best placed to capture the value from the Healthcare Revolution.

The future will be shaped by fundamental paradigm shifts ushering in a new era of more effective medicine. Diagnosis, prevention and treatment will be linked more closely than ever before in integrated strategies offering patients and healthcare providers highly focused, individualised care. We are confident that, with our outstanding workforce, cutting-edge science and state-of-the-art technology base, we can meet tomorrow's needs for integrated healthcare solutions.

MISSION

As one of the world's leading innovation-driven healthcare groups, whose core businesses are Pharmaceuticals and Diagnostics, Taj Pharmaceuticals aims to supply products and services that significantly improve people's lives by helping to prevent, diagnose and treat disease.

Taj Pharmaceuticals is committed to a system of corporate governance that conforms to the latest standards and takes due account of our corporate development. The safety and health of our employees and the public, as well as the protection of our neighbourhoods and the environment, have high priority at all Group facilities. In all we do, we are guided by the principle of sustainable development.

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Brutrax® (Aastrozole Tablet) may help reduce your risk of breast cancer recurrence sold by Taj Pharmaceuticals Limited (India), a global pharmaceuticals company. It is available in India, Middle East and a few other South Asian countries.

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Information for Health Care Professionals
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