Medication info
Teva Letrozole Tablet 2.5 mg

Teva Letrozole Tablet 2.5 mg

Prescription medicationTabletOral
Ingredient · strength
Letrozole›2.5mg / 1 tablet
Manufacturer / importer
TEVA-HANDOK PHARMA CO., LTD.
Appearance
Dark yellow, convex round film-coated tablet
Packaging
30 tablets (10 tablets/PTP×3)
Approval status
Active

MFDS item code 201500998 · Approved 2015.02.25 · Insurance code 626900490

Summary

Main use
Treatment of advanced and early breast cancer in postmenopausal women
Who takes it
Adults
Adult dose
○ Adults and older adults: The recommended dose is letrozole 2.5 mg orally once daily, with or without food. If a dose is missed, take it as soon as remembered. However, if it is nearly time for the next dose, skip the missed dose and follow 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. For patients with metastatic disease, continue treatment until cancer progression is confirmed. For adjuvant therapy and extended adjuvant therapy after adjuvant tamoxifen, treatment may be given for 5 years. If cancer recurs during treatment, discontinue the medicine (for extended adjuvant therapy after adjuvant tamoxifen, the optimal duration of treatment associated with long-term administration 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 dosage 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), continuous and careful supervision is required. ○ Patients with renal impairment: No dosage adjustment is necessary for patients with renal impairment and creatinine clearance of 10 mL/min or higher.

Ingredients

Importer
TEVA-HANDOK PHARMA CO., LTD.

Efficacy & effects

Treatment of advanced and early breast cancer in postmenopausal women

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

This medicine is used in the treatment of hormone receptor-positive or receptor status unknown breast cancer in postmenopausal women. It is effective as the first-line treatment for locally advanced or metastatic breast cancer and can be used if the disease recurs after anti-estrogen therapy. It is also used as extended adjuvant therapy after tamoxifen in patients with invasive early breast cancer. It particularly helps prevent disease recurrence when hormone receptor-positive. This drug is effectively used in the treatment and prevention of breast cancer.

How to take

Adult dose

○ Adults and older adults: The recommended dose is letrozole 2.5 mg orally once daily, with or without food. If a dose is missed, take it as soon as remembered. However, if it is nearly time for the next dose, skip the missed dose and follow 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. For patients with metastatic disease, continue treatment until cancer progression is confirmed. For adjuvant therapy and extended adjuvant therapy after adjuvant tamoxifen, treatment may be given for 5 years. If cancer recurs during treatment, discontinue the medicine (for extended adjuvant therapy after adjuvant tamoxifen, the optimal duration of treatment associated with long-term administration 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 dosage 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), continuous and careful supervision is required. ○ Patients with renal impairment: No dosage adjustment is necessary for patients with renal impairment and creatinine clearance of 10 mL/min or higher.

Precautions

This drug should not be administered to certain patients. For instance, patients with an allergy to this drug or its components, premenopausal women, those who are pregnant or may become pregnant, and patients with lactose intolerance or genetic lactose-related disorders should not use this drug. Additionally, patients with severely impaired renal function or significant liver dysfunction, those with a history of osteoporosis or at high risk of fractures, women whose menopausal status is uncertain, and patients allergic to certain dyes should use this drug with caution. Due to its effect of lowering estrogen levels, this drug may increase the risk of decreased bone density and osteoporosis, so regular bone density testing is needed if used long-term, along with prevention and treatment of osteoporosis. While taking this drug, symptoms such as hot flashes, joint pain, nausea, fatigue may occur, and various side effects such as hypercholesterolemia, depression, headache, hair loss, skin dryness, vaginal bleeding, etc. may arise. Serious adverse reactions such as thrombosis, heart failure, liver dysfunction, and severe skin reactions may occur, so one should consult a doctor immediately if symptoms arise. Dizziness or drowsiness may occur during driving or operating machinery, so caution is needed. This drug is metabolized in the liver, so the blood concentration may change when used together with drugs that inhibit or induce certain liver metabolic enzymes, thus drug interactions should be monitored. Use during pregnancy may pose risks to the fetus, so women who may become pregnant must ensure adequate contraception, and pregnant or nursing women should not use this drug. The safety and efficacy of this drug in children under 17 years have not been established. In case of overdose, there is no specific antidote, so symptomatic treatment and monitoring of vital signs are necessary. When storing, keep out of reach of children, and store in the original container to prevent quality degradation or misuse.

Side effects

  • urinary tract infection
  • pain from neoplasm
  • leukopenia
  • anaphylactoid reaction
  • hypercholesterolemia
  • loss of appetite
  • increased appetite
  • depression
  • anxiety
  • hypersensitivity
Show 74 more
  • headache
  • dizziness
  • lightheadedness
  • drowsiness
  • insomnia
  • memory impairment
  • sensory disturbances
  • taste disorders
  • cerebrovascular disease
  • carpal tunnel syndrome
  • cataract
  • eye irritation
  • blurred vision
  • palpitations
  • increased heart rate
  • ischemic heart events
  • flushing
  • hypertension
  • thrombolytic venous inflammation
  • pulmonary embolism
  • arterial thrombosis
  • cerebrovascular infarction
  • difficulty breathing
  • 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
  • urinary frequency
  • vaginal bleeding
  • vaginal discharge
  • vulvar dryness
  • mastalgia
  • 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 drug should be stored in a closed container to avoid exposure to air or moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Dark yellow, convex round film-coated tablet

Package unit

30 tablets (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.

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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.