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Important Information About ARIMIDEX

ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.

ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.

Important Safety Information About ARIMIDEX

  • Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child
  • Based on information from a study in patients with early breast cancer, women with a history of blockages in heart arteries (ischemic heart disease) who take ARIMIDEX may have a slight increase in this type of heart disease compared to similar patients who take tamoxifen
  • ARIMIDEX can cause bone softening/weakening (osteoporosis) increasing the chance of fractures. In a clinical study in early breast cancer, there were more fractures (including fractures of the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen (7%)
  • In a clinical study in early breast cancer, some patients taking ARIMIDEX had an increase in cholesterol. Skin reactions, allergic reactions, and changes in blood tests of liver function have also been reported
  • In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms (including arthritis and arthralgia), weakness, mood changes, pain, back pain, sore throat, nausea and vomiting, rash, depression, high blood pressure, osteoporosis, fractures, swelling of arms/legs, insomnia, and headache
  • In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, headache, bone pain, increased cough, shortness of breath, sore throat, and swelling of arms and legs. Joint pain/stiffness has been reported in association with the use of ARIMIDEX
  • ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies

Please click hereAdobe PDF document for full Prescribing Information.

Important Information About FASLODEX

FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

Important Safety Information About FASLODEX

  • Prescription FASLODEX is only for postmenopausal women. Do not take FASLODEX if you are pregnant and do not become pregnant while taking FASLODEX, because it may harm your unborn child. (See WARNINGS and CONTRAINDICATIONS sections of full Prescribing Information)
  • Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin)
  • In clinical studies, the most commonly reported side effects were nausea, vomiting, constipation, diarrhea, abdominal pain, headache, back pain, hot flashes, sore throat, and injection site reactions with mild, transient pain and inflammation

Please see full Prescribing InformationAdobe PDF document. For more information, see your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).