Medication info
Petra Tablet (Letrozole)

Petra Tablet (Letrozole)

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

MFDS item code 202403042 · Approved 2024.12.23 · Insurance code 647805860

Summary

Main use
Treatment of advanced breast cancer in postmenopausal women, and adjuvant and extended adjuvant treatment of early breast cancer
Who takes it
Adults
Adult dose
○ Adults and elderly patients : The recommended dose is 2.5 mg of letrozole orally once daily, regardless of meals. If a dose is missed, take it as soon as you remember. However, if it is close to the time for the next dose, skip the missed dose and continue taking the medicine according to 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 adjuvant tamoxifen therapy, treatment may be given for 5 years. If cancer recurs during treatment, discontinue the medicine (for extended adjuvant therapy following adjuvant tamoxifen therapy, the optimal treatment duration associated with long-term use has not been established.). ○ Patients with hepatic impairment : Although the blood concentration of this medicine is slightly increased in patients with moderate hepatic impairment due to cirrhosis, no dose adjustment is necessary in patients with mild to 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 dose adjustment is necessary in patients with renal impairment and a creatinine clearance of 10 mL/min or more.

Ingredients

Manufacturer
Samjin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of advanced breast cancer in postmenopausal women, and adjuvant and extended adjuvant treatment of early breast cancer

  • Locally advanced breast cancer
  • metastatic breast cancer
  • recurrent 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 particularly effective when the estrogen or progesterone receptors are positive or when the status is unknown. It can be used as a first-line treatment for locally advanced or metastatic breast cancer. Additionally, it is prescribed for patients with advanced breast cancer who have recurred after anti-estrogen therapy. It may also be utilized as an extended adjuvant therapy following 5 years of tamoxifen adjuvant therapy in early invasive breast cancer patients. It enhances the treatment effect for adjuvant therapy in hormone receptor-positive invasive early breast cancer.

How to take

Adult dose

○ Adults and elderly patients : The recommended dose is 2.5 mg of letrozole orally once daily, regardless of meals. If a dose is missed, take it as soon as you remember. However, if it is close to the time for the next dose, skip the missed dose and continue taking the medicine according to 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 adjuvant tamoxifen therapy, treatment may be given for 5 years. If cancer recurs during treatment, discontinue the medicine (for extended adjuvant therapy following adjuvant tamoxifen therapy, the optimal treatment duration associated with long-term use has not been established.). ○ Patients with hepatic impairment : Although the blood concentration of this medicine is slightly increased in patients with moderate hepatic impairment due to cirrhosis, no dose adjustment is necessary in patients with mild to 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 dose adjustment is necessary in patients with renal impairment and a creatinine clearance of 10 mL/min or more.

Precautions

This medication should not be used in certain patients. Women who are allergic to this medication or its components, premenopausal women, pregnant or possibly pregnant women, and breastfeeding women should not take this medication. Additionally, this medication contains lactose, so patients with lactose intolerance or certain genetic metabolic disorders should also avoid it. Patients with significantly impaired kidney function, severe liver dysfunction, a history of osteoporosis, or high fracture risk need special caution when using this medication. Patients whose menopausal status is uncertain should confirm their menopause status through hormone testing before taking this medication. Patients with allergies to the coloring agents in this medication should also use it with caution. This medication is primarily used for the treatment of breast cancer in women and works by inhibiting the production of estrogen hormones. This can lead to common side effects such as facial flushing, arthralgia, nausea, fatigue, hair loss, vaginal bleeding, loss of appetite, headache, dizziness, sleepiness, insomnia, memory impairment, sensory abnormalities, taste disturbances, cataract, eye irritation, blurred vision, palpitations, tachycardia, hypertension, cough, vomiting, indigestion, constipation, diarrhea, abdominal pain, stomatitis, dry mouth, increased liver enzymes, sweating, dry skin, rash, itching, hives, angioedema, erythema multiforme. Serious side effects, such as cardiac problems, thrombosis, liver dysfunction, and skin allergic reactions may rarely occur, and if symptoms appear, immediate consultation with medical personnel is necessary. This medication is metabolized in the liver, so interactions with other medications may occur. Particularly, concomitant use of drugs that inhibit or induce liver enzymes may alter the effects of this medication, so any other medications that are being taken must be disclosed. It may pose risks to pregnant or breastfeeding women and should never be taken, requiring adequate contraception for premenopausal women. The safety and efficacy of this medication have not been established in children under 17 years of age. Elderly patients do not require special dosage adjustments, but caution is necessary due to a higher risk of fractures. In case of overdose, there is no specific antidote, so symptomatic treatment and monitoring of the condition are important. This medication should be kept out of the reach of children and stored in its original container to prevent quality degradation and misuse.

Side effects

  • urinary tract infection
  • tumor pain
  • leukopenia
  • anaphylactoid reaction
  • hypercholesterolemia
  • loss of appetite
  • increased appetite
  • depression
  • anxiety
  • irritability
Show 74 more
  • headache
  • dizziness
  • vertigo
  • drowsiness
  • insomnia
  • memory impairment
  • sensory disturbances
  • taste disorders
  • cerebrovascular disease
  • carpal tunnel syndrome
  • cataract
  • eye irritation
  • blurred vision
  • palpitations
  • tachycardia
  • ischemic heart event
  • facial flushing
  • hypertension
  • thrombophlebitis
  • pulmonary embolism
  • arterial thrombosis
  • cerebral infarction
  • shortness of breath
  • cough
  • nausea
  • vomiting
  • dyspepsia
  • constipation
  • diarrhea
  • abdominal pain
  • stomatitis
  • dry mouth
  • elevated liver enzymes
  • hyperbilirubinemia
  • jaundice
  • hepatitis
  • excessive sweating
  • 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
  • vaginal bleeding
  • vaginal discharge
  • vulvar dryness
  • breast pain
  • fatigue
  • peripheral edema
  • chest pain
  • generalized edema
  • fever
  • dry mucous membranes
  • thirst
  • weight gain
  • weight loss
  • elevated aminotransferase levels
  • falls
  • peripheral neuropathy
  • arrhythmia
  • hematuria

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and kept in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 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.