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Description

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Dosage and Administration

The dose of ARIMIDEX (Anastrozole)  is one 1 mg tablet taken once a day. For patients with advanced breast cancer, ARIMIDEX(Anastrozole) should be continued until tumor progression. ARIMIDEX (Anastrozole) can be taken with or without food.

For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown. In the ATAC trial, ARIMIDEX(Anastrozole) was administered for five years

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CONTRAINDICATIONS

ARIMIDEX(Anastrozole) may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. ARIMIDEX(Anastrozole) is contraindicated in women who are or may become pregnant. There are no adequate and well-controlled studies in pregnant women using ARIMIDEX(Anastrozole)If ARIMIDEX(Anastrozole) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus or potential risk for loss of the pregnancy.

 

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Side Effects

  • Headache
  • Hot flushes
  • Feeling sick (nausea)
  • Skin rash
  • Pain or stiffness in your joints
  • Inflammation of the joints (arthritis)
  • Feeling weak
  • Bone loss (osteoporosis)
  • Raised or high levels of a fatty substance known as cholesterol in your blood.
  • This would be seen in a blood test
  • Feeling sleepy
  • Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)
  • An extremely severe skin reaction with ulcers or blisters on the skin. This is
  • known as ‘Stevens-Johnson syndrome’Allergic (hypersensitivity) reactions with swelling of the throat that may cause
  • difficulty in swallowing or breathing. This is known as ‘angioedema’

 

Warnings

Cholesterol: During the ATAC trial, more patients receiving ARIMIDEX(Anastrozole) were reported to have elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively).

Ischemic Cardiovascular Events In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX(Anastrozole) in the ATAC trial (17% of patients on ARIMIDEX and 10% of patients on tamoxifen). Consider risk and benefits of ARIMIDEX therapy in patients with pre-existing ischemic heart disease.

Bone Effects: Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX(Anastrozole) had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline more info :

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