Medication info
Letrozole 2.5 mg

Letrozole 2.5 mg

Prescription medicationTabletOral
Ingredient · strength
Letrozole›2.5mg / 1 tablet
Manufacturer / importer
Boryung Pharmaceutical Co., Ltd.
Appearance
Dark yellow, round film-coated tablets
Packaging
30 tablets/box [10 tablets/PTP×3]
Approval status
Active

MFDS item code 202402459 · Approved 2024.10.18 · Insurance code 641908520

Summary

Main use
Treatment of breast cancer (early-stage, advanced, etc.) in postmenopausal women
Who takes it
Adults
Adult dose
○ Adults and older adults: The recommended dose is 2.5 mg of letrozole orally once daily, with or without food. If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your 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 adjuvant tamoxifen, treatment may be continued for 5 years. If cancer recurs during treatment, discontinue treatment (for extended adjuvant therapy following adjuvant tamoxifen, the optimal treatment duration associated with long-term use has not been established). ○ Patients with hepatic impairment: Blood concentrations of this medicine increase slightly in patients with moderate hepatic impairment due to cirrhosis, but no dose adjustment is required in patients with mild to moderate hepatic impairment. However, patients with severe hepatic impairment (Child-Pugh score C) should be under continuous and careful supervision when using this medicine. ○ Patients with renal impairment: No dose adjustment is required in patients with renal impairment and a creatinine clearance of 10 mL/min or higher.

Ingredients

Manufacturer
Boryung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of breast cancer (early-stage, advanced, etc.) in postmenopausal women

  • Locally advanced breast cancer
  • metastatic breast cancer
  • relapsed advanced breast cancer
  • invasive early breast cancer
View approved original text

This medication is used for the treatment of breast cancer in postmenopausal women. It is effective as a first-line treatment for advanced or metastatic breast cancer when estrogen or progesterone receptors are positive or receptor status is unknown. Furthermore, it helps in the treatment of advanced breast cancer in postmenopausal women who have relapsed after anti-estrogen therapy. This drug is used for extended adjuvant therapy following five years of tamoxifen adjuvant therapy in patients with invasive early breast cancer, as well as in the adjuvant therapy for invasive early breast cancer in hormone receptor-positive postmenopausal women. Overall, it plays an important role in the treatment of breast cancer and prevention of recurrence in postmenopausal women.

How to take

Adult dose

○ Adults and older adults: The recommended dose is 2.5 mg of letrozole orally once daily, with or without food. If you miss a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your 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 adjuvant tamoxifen, treatment may be continued for 5 years. If cancer recurs during treatment, discontinue treatment (for extended adjuvant therapy following adjuvant tamoxifen, the optimal treatment duration associated with long-term use has not been established). ○ Patients with hepatic impairment: Blood concentrations of this medicine increase slightly in patients with moderate hepatic impairment due to cirrhosis, but no dose adjustment is required in patients with mild to moderate hepatic impairment. However, patients with severe hepatic impairment (Child-Pugh score C) should be under continuous and careful supervision when using this medicine. ○ Patients with renal impairment: No dose adjustment is required in patients with renal impairment and a creatinine clearance of 10 mL/min or higher.

Precautions

This medication should not be used by individuals who are allergic to this drug or its components, premenopausal women, pregnant or potentially pregnant women, and breastfeeding women. Those with severely impaired renal function or significant liver dysfunction should use this medication with caution, and those with a history of osteoporosis or at high risk of fractures should have regular bone density tests and closely monitor their bone health. If menopause status is uncertain, hormone testing should be conducted to confirm menopausal status before taking this medication. This drug contains certain dye components, so care is needed for those who are allergic to these ingredients. While taking this medication, symptoms related to estrogen deficiency, such as facial flushing, arthralgia, nausea, and fatigue, may occur, and occasionally thrombosis, heart problems, liver function abnormalities, or skin adverse reactions may arise. Consult a physician immediately if abnormal symptoms occur. Due to the risk of osteoporosis and fractures, continuous monitoring of bone health is needed, and appropriate treatment should be sought if necessary. This medication is metabolized in the liver, so caution is required for patients with impaired liver function or those taking other drugs that affect certain liver enzymes due to potential drug interactions. Pregnant women or those planning pregnancy should not take this medication, and premenopausal women should employ adequate contraception. The safety and efficacy of this medication have not been established in children under 17 years of age. There is no need for special dosage adjustments in the elderly, but caution is warranted due to the higher risk of fractures. In case of overdose, there are no specific antidotes, and appropriate treatment and observation based on symptoms are necessary. This medication should be stored out of reach of children and kept in its original container to prevent misuse or deterioration in quality. Caution is required during driving or operating machinery as fatigue or dizziness may occur.

Side effects

  • Urinary tract infection
  • pain from mass
  • leukopenia
  • anaphylactic reaction
  • hypercholesterolemia
  • loss of appetite
  • increased appetite
  • depression
  • anxiety
  • irritability
Show 74 more
  • headache
  • dizziness
  • vertigo
  • drowsiness
  • insomnia
  • memory impairment
  • sensory disturbances
  • taste disorder
  • cerebrovascular disease
  • carpal tunnel syndrome
  • cataract
  • eye irritation
  • blurred vision
  • palpitations
  • increased heart rate
  • ischemic heart event
  • facial flushing
  • hypertension
  • thrombophlebitis
  • pulmonary embolism
  • arterial thrombosis
  • cerebrovascular infarction
  • dyspnea
  • cough
  • nausea
  • vomiting
  • indigestion
  • constipation
  • diarrhea
  • abdominal pain
  • stomatitis
  • dry mouth
  • increased liver enzymes
  • hyperbilirubinemia
  • jaundice
  • hepatitis
  • hyperhidrosis
  • alopecia
  • dry skin
  • rash
  • itching
  • urticaria
  • angioedema
  • toxic epidermal necrolysis
  • erythema multiforme
  • arthralgia
  • myalgia
  • bone pain
  • osteoporosis
  • fracture
  • arthritis
  • back pain
  • tendinitis
  • tendon rupture
  • trigger finger
  • frequent urination syndrome
  • vaginal bleeding
  • vaginal discharge
  • dryness of the vulva
  • breast pain
  • fatigue
  • peripheral edema
  • chest pain
  • generalized edema
  • fever
  • dry mucous membranes
  • thirst
  • weight gain
  • weight loss
  • increased levels of aminotransferases
  • fall
  • peripheral neuropathy
  • arrhythmia
  • hematuria

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It should also be kept in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Dark yellow, round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP×3]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.