ANASTROZOLE (ARIMIDEX) 1 MG/TABLET – 50 TABLETS

• Anastrozole 1 mg contains anastrozole, an aromatase inhibitor administered orally in tablet form. According to the supplied product information, each tablet contains 1 mg of anastrozole, and the product is presented as a prescription medicine manufactured by Hilma Biocare.Anastrozole was developed for use in hormone-sensitive breast cancer, particularly in post-menopausal women. It works by inhibiting the aromatase enzyme, which is involved in the conversion of certain androgens into oestrogen. By reducing oestrogen production, anastrozole can reduce the hormonal stimulation associated with oestrogen-dependent breast cancer.

  Unlike anabolic steroids, anastrozole is not an anabolic-androgenic steroid. It belongs to the pharmacological class known as aromatase inhibitors. Its mechanism is based on reducing oestrogen synthesis rather than directly supplying or replacing testosterone.

  The supplied clinical pharmacology information describes anastrozole as capable of substantially reducing circulating oestrogen levels. Changes in hormonal balance may also affect testosterone, luteinising hormone (LH) and follicle-stimulating hormone (FSH). The extent of these hormonal changes can vary between individuals and depends on factors such as sex, age, hormonal status and the reason for treatment.

  Anastrozole is primarily associated with treatment in post-menopausal women with certain forms of breast cancer. The supplied information also mentions use in some male patients with low testosterone levels; however, such use should only be considered when specifically assessed and prescribed by a qualified healthcare professional.

  Because anastrozole significantly affects oestrogen levels, treatment requires appropriate medical consideration. Oestrogen plays an important role in maintaining bone health, cardiovascular function and other physiological processes. Excessive reduction of oestrogen can therefore contribute to unwanted effects, including reduced bone mineral density and an increased risk of fractures.

  Reported adverse reactions include hot flushes, weakness, joint pain, arthritis, hypertension, depression, nausea, vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral oedema, cough, shortness of breath and lymphoedema. Anastrozole may also cause dizziness, which can affect activities such as driving or operating machinery.

  Serious reactions described in the supplied information include severe skin reactions, allergic reactions such as anaphylaxis or angioedema, and changes in liver function. Patients experiencing facial, lip, tongue or throat swelling or difficulty breathing require urgent medical attention.

  Anastrozole is contraindicated in patients with known hypersensitivity to anastrozole or its excipients. The supplied information also states that it should not be administered during pregnancy because of the potential for fetal harm. Its use in premenopausal women with breast cancer is not considered to provide clinical benefit according to the supplied information.

  Particular caution is advised in patients with pre-existing cardiovascular disease. The supplied information reports an increased incidence of ischaemic cardiovascular events in patients with pre-existing ischaemic heart disease in the ATAC trial. Changes in serum cholesterol may also occur during treatment.

  Drug interaction information supplied for anastrozole indicates that studies involving warfarin did not demonstrate clinically significant changes in exposure or anticoagulant activity. The supplied pharmacological information also states that clinically important interactions through cytochrome P450 inhibition are considered unlikely.

  Treatment with anastrozole should therefore be based on an appropriate medical assessment. Patients should follow the dosage and duration prescribed by their healthcare professional rather than adjusting treatment independently.

  The product is supplied as 1 mg uncoated tablets, with 50 tablets in one bottle. The supplied storage instructions recommend keeping the product between 15–25°C and protecting it from light.

  Product Specifications

• Product: Anastrozole (Arimidex)
  Strength: 1 mg per tablet
  Active Ingredient: Anastrozole
  Molecular Formula: C17H19N5
  Molecular Weight: 293.374 g/mol
  CAS Number: 120511-73-1
  Dosage Form: Tablet
  Route: Oral
  Market Status: Prescription
  Company: Hilma Biocare
  Presentation: 50 tablets per bottle
  IndicationsThe supplied information identifies anastrozole for the treatment of certain types of breast cancer in post-menopausal women, including disease that has progressed following tamoxifen therapy.

  Any other use should be determined by a qualified healthcare professional based on the patient’s individual clinical circumstances.

  Clinical Pharmacology

  Anastrozole is an aromatase inhibitor. Aromatase is involved in the production of oestrogen from androgenic substrates.

  By inhibiting aromatase, anastrozole reduces oestrogen production. This pharmacological action forms the basis for its use in hormone-sensitive breast cancer.

  Adverse Reactions

  Reported adverse reactions include:

  Hot flushes
  Weakness or asthenia
  Joint pain and arthritis
  Hypertension
  Depression
  Nausea and vomiting
  Rash
  Osteoporosis
  Fractures
  Back pain
  Insomnia
  Headache
  Bone pain
  Peripheral oedema
  Cough
  Dyspnoea
  Lymphoedema
  Dizziness
  Changes in liver function

  Rare serious reactions include severe skin reactions, anaphylaxis, angioedema and liver inflammation.

  Contraindications

  Anastrozole is contraindicated in patients with:

  Known hypersensitivity to anastrozole
  Hypersensitivity to any of the product’s excipients
  Pregnancy, because of potential fetal harm

  The supplied information states that anastrozole offers no clinical benefit for premenopausal women with breast cancer.

  Precautions

  Particular caution is advised in patients with:

  Pre-existing ischaemic heart disease
  Increased cardiovascular risk
  Risk factors for reduced bone mineral density
  Existing liver problems
  Conditions requiring monitoring of cholesterol levels

  Because anastrozole can reduce oestrogen, prolonged treatment may affect bone health and increase fracture risk.

  Drug Interactions

  The supplied information specifically discusses:

  Warfarin: Clinical study data supplied with the product indicate that anastrozole did not significantly alter warfarin exposure or measured anticoagulant activity.

  Cytochrome P450: The supplied information states that clinically significant interactions through inhibition of cytochrome P450 are considered unlikely.

  Patients should nevertheless inform their healthcare professional about all medicines and supplements they use before starting treatment.

  Dosage & Administration

  The appropriate dose and duration of anastrozole depend on the medical indication and the individual patient.

  For approved treatment, patients should follow the dose prescribed by their doctor or the instructions supplied with the medicine. The bodybuilding or post-cycle-treatment dosing schedules contained in the supplied source have not been reproduced because they are not appropriate as general medical dosing guidance.

  Do not increase, reduce or change the frequency of anastrozole without medical advice.

  Presentation

  Anastrozole 1 mg uncoated tablets — 50 tablets in one bottle.

  Storage

  Store between 15–25°C.

  Protect from light.