Bretara Tablet (Letrozole)

Adult dose

○ Adults and older adults : The recommended dose is letrozole 2.5 mg orally once daily, regardless of meals. If a dose is missed, take it as soon as remembered. However, if it is close to the time for the next dose, skip the missed dose and resume the regular schedule. Do not take a double dose to make up for a missed dose; do not exceed the recommended dose of 2.5 mg. In patients with metastatic disease, continue treatment until disease progression is confirmed. For adjuvant therapy and extended adjuvant therapy following tamoxifen adjuvant therapy, treatment may be continued for 5 years. If cancer recurs during treatment, discontinue treatment (for extended adjuvant therapy following tamoxifen adjuvant therapy, the optimal treatment duration associated with long-term use has not been established.). ○ Patients with hepatic impairment : Blood concentrations of this medicine are slightly increased in patients with moderate hepatic impairment due to cirrhosis, but no dose adjustment is necessary in patients with mild ～ moderate hepatic impairment. However, if this medicine is used in patients with severe hepatic impairment (Child-Pugh score C), ongoing and careful supervision is required. ○ Patients with renal impairment : No dose adjustment is necessary in patients with renal impairment and creatinine clearance of 10 mL/min or higher.

This medication should not be administered to certain patients. Individuals with allergies to this medication or its components, premenopausal women, and women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Patients with severely impaired kidney function or severe liver dysfunction should use this medication with caution. In particular, patients with liver dysfunction should have careful monitoring and dosage adjustment, as drug concentration in the body may increase. Patients with a history of osteoporosis or those at high risk of fractures should undergo regular bone density tests and require appropriate prevention and treatment, as this medication may reduce bone density. In cases where menopause status is uncertain, hormone tests should be conducted to confirm menopause before taking this medication. This medication may frequently cause side effects such as facial flushing, arthralgia, nausea, and fatigue due to its action in lowering estrogen levels. Abnormal reactions have been reported in various areas, including blood, liver, heart, skin, and musculoskeletal system, so consult a doctor if symptoms occur. Particular attention should be paid to possible occurrences of thrombosis, heart failure, angina, liver dysfunction, and severe skin reactions; if these symptoms appear, treatment should be stopped immediately and medical personnel should be notified. It is important to periodically monitor bone health during the course of taking this medication to reduce the risk of osteoporosis and fractures. Liver function tests (especially AST, ALT, and bilirubin) should be regularly conducted to check for abnormalities in liver function. Since this medication is metabolized in the liver, the drug concentration may vary when taken with medications that inhibit or induce certain liver enzymes, so inform your doctor or pharmacist if you are taking other medications. Women who are pregnant or breastfeeding should avoid taking this medication as it may harm the fetus or newborn, and premenopausal women should use adequate contraception. The safety and efficacy of this medication have not been established for children under 17 years of age. For older adults, dosage adjustments are not necessary, but caution is warranted as the risk of fractures may be higher. In cases of overdose, no specific antidote is available; appropriate treatment and monitoring of vital signs according to symptoms are necessary. Store in a sealed container to protect from air and moisture, and keep it in its original container to prevent deterioration or misuse. This medication may induce fetal toxicity, so women who may become pregnant must consult a physician before use.

• Urinary tract infection
• pain from masses
• leukopenia
• anaphylaxis-like reactions
• hypercholesterolemia
• loss of appetite
• increased appetite
• depression
• anxiety
• irritability

This medication is sensitive to air and moisture; therefore, it must be stored in a sealed container. Additionally, it should be kept in a cool place below 30 degrees Celsius to maintain the medication's efficacy.

Appearance

Dark yellow, round film-coated tablet

Package unit

30 tablets/box (10 tablets/PTP x 3)