Arofrez 2.5 mg (Tablet)

Indications

• Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
• First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer
• Treatment of advanced breast cancer in women with natural or artificially induced postmenopausal status
• Pre-operative therapy in postmenopausal women with localized hormone receptor positive breast cancer

Pharmacology

• Potent and highly specific nonsteroidal aromatase inhibitor
• Reduction of estrogen biosynthesis in all tissues
• Suppression of estrogen biosynthesis in peripheral and malignant tissues
• No effect on plasma androgen concentrations

Dosage & Administration

• Recommended dose of 2.5 mg once daily
• Treatment should continue for 5 years or until tumor relapse occurs
• No dose adjustment for elderly patients
• No dosage adjustment for patients with hepatic impairment or renal impairment

Interaction

• No clinically significant drug reactions observed with cimetidine and warfarin co-administration

Contraindications

• Contraindicated in known or suspected hypersensitivity to letrozole or other aromatase inhibitors
• Contraindicated during pregnancy, lactation, and in pre-menopausal women
• Contraindicated in severe hepatic dysfunction

Side Effects

• Common side effects include hot flushes, increased cholesterol levels, fatigue, increased sweating, pain in bones and joints, skin rash, headache, dizziness, gastrointestinal disorders, and more
• Rare side effects include nervous disorders, eye disorders, weight decrease, urinary tract infection, and more

Pregnancy & Lactation

• Teratogenicity and maternal toxicity observed in pregnant rats
• No adequate and well-controlled studies in pregnant women
• Not recommended for use in nursing women

Precautions & Warnings

• Caution recommended in breast cancer patients with moderate hepatic dysfunction
• Renal impairment did not affect steady-state plasma concentration at a dose of 2.5 mg or 5 mg
• Potential risks and benefits should be considered before prescribing
• Fatigue and dizziness observed in some cases

Overdose Effects

• No clinical experience of overdosage
• No specific antidote available
• Supportive care and frequent monitoring of vital signs appropriate

Therapeutic Class

• Hormonal Chemotherapy

Storage Conditions

• Keep below 30°C temperature, away from light & moisture
• Keep out of the reach of children

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