Anacare1mg

• Adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women
• First-line treatment of hormone receptor-positive or unknown locally advanced or metastatic breast cancer in postmenopausal women
• Second-line treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Adult Dose:

• Recommended dose: 1 mg tablet once daily
• Adjuvant treatment of early breast cancer: Optimal duration unknown
• Advanced breast cancer: Continue until tumor progression

Hepatic Dose: No dose adjustment needed for mild-to-moderate hepatic impairment. Not studied in severe hepatic impairment.

Renal Dose: No dose adjustment necessary for renal impairment.

Special Populations: Pharmacokinetics not affected by age. Safety and efficacy in pediatric patients not established.

Common (>10%):

• Hot flashes
• Asthenia
• Arthritis
• Pain
• Arthralgia
• Hypertension
• Depression
• Nausea and vomiting
• Rash
• Osteoporosis
• Fractures
• Back pain
• Insomnia
• Headache
• Bone pain
• Peripheral edema
• Increased cough
• Dyspnea
• Pharyngitis
• Lymphedema

Rare (<0.01%):

• Skin reactions (lesions, ulcers, blisters)
• Allergic reactions (swelling of face, lips, tongue, throat - difficulty swallowing and/or breathing)
• Liver function changes (jaundice, liver pain or swelling)

Serious Precautions:

• Do not use during pregnancy or in premenopausal women
• Caution in pre-existing ischemic heart disease (increased risk of ischemic cardiovascular events)
• Bone density decrease and osteoporosis may occur - regular bone density testing recommended
• Cholesterol may increase - regular monitoring needed
• May cause weakness and sleepiness - do not drive if affected
• If nausea bothers you, take after meals
• Regular Vitamin D and bone mineral density monitoring recommended