Valid Ghana · FDA Ghana

FEMARA TABLETS

LETRASOLE

FDA/SD.255-123459 LETRASOLE 2.5mg

What it does

Letrasole is a medication often used in cancer treatment.

Commonly used for: breast cancer, hormone-sensitive breast cancer

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Registration & product details

Registration no.
FDA/SD.255-123459
Registration date
2025-12-30
Expiry date
2030-12-31
Status
Valid
Active ingredient
LETRASOLE
Dosage form
LETRASOLE
Strength
2.5mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Novartis
Applicant / LTR
Novartis Ghana Ltd
Country of origin
Belgium
Manufacturer location
Rijksweg 14, 2870 Puurs-Sint-Amands, Belgium

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:58 · updated 2026-09-25 04:00:08

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Letrasole is a medication often used in cancer treatment.

What it treats

  • breast cancer
  • hormone-sensitive breast cancer

How it works

Letrasole works by lowering the amount of estrogen in the body, which can help slow or stop the growth of certain types of breast tumors that need estrogen to grow.

Who it's for

This medicine is typically prescribed for women who have had surgery for breast cancer and are at risk of the cancer returning.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: letrasole

Letrasole, also known as letrozole, is an aromatic anti-estrogen used primarily in hormone receptor-positive breast cancer treatment in postmenopausal women. It functions by inhibiting aromatase, an enzyme crucial for estrogen synthesis, thereby lowering estrogen levels in the body. This reduction in estrogen can slow or stop the growth of hormone-sensitive tumors.

Indications

  • Hormone receptor-positive breast cancer in postmenopausal women
  • Adjuvant treatment of early breast cancer
  • Advanced breast cancer in postmenopausal women

Dosage

Children: Letrasole is not indicated for use in children. Refer to the BNF for Children for further information.

Adults: Refer to the BNF for specific adult dosing regimens based on the type and stage of breast cancer.

Mechanism of action

Letrozole selectively inhibits the aromatase enzyme, which is responsible for converting androgens into estrogens in peripheral tissues. By blocking this pathway, letrozole significantly decreases circulating estrogen levels, which is essential for the growth of certain breast cancers that rely on estrogen for proliferation.

Pharmacodynamics

Letrozole exhibits its pharmacological effects by inhibiting estrogen synthesis, leading to a decrease in estrogen-dependent tumor growth. The drug's effectiveness in reducing estrogen levels is directly correlated with its ability to inhibit aromatase, thereby contributing to lower rates of tumor recurrence and improved survival outcomes in patients with estrogen receptor-positive breast cancer.

Pharmacokinetics

Letrozole is well-absorbed following oral administration, with a bioavailability of approximately 99.9%. It is extensively metabolized in the liver, primarily by the cytochrome P450 enzyme CYP2A6, leading to several metabolites, although none are considered pharmacologically active. The elimination half-life of letrozole is around 2 days, and it is excreted mainly through urine as metabolites. Steady-state concentrations are reached within 2 to 6 weeks of continuous dosing.

Contra-indications

  • Hypersensitivity to letrasole or any of its components
  • Severe liver impairment
  • Pregnancy

Adverse effects

  • Nausea
  • Vomiting
  • Fatigue
  • Headache
  • Dizziness
  • Hot flashes
  • Hypertension
  • Arthralgia
  • Bone pain

Interactions

  • Increased risk of toxicity when used with strong CYP3A4 inhibitors
  • Reduced effectiveness when used with CYP3A4 inducers

Precautions

  • Monitor liver function during treatment
  • Use with caution in patients with a history of cardiovascular disease
  • Assess bone health due to potential for bone density loss

Pregnancy

Letrasole is contraindicated in pregnancy due to the potential risk of fetal harm.

Breast-feeding

It is not known whether letrasole is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.