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Exebenz 25 tablets

Generic Name: Exemestane

Drug Class- Antineoplastic agent

Exemestane is a third-generation, selective, irreversible, steroidal aromatase inhibitor, effective for treatment of postmenopausal patients with early-stage or advanced breast cancer. It is also used as second-line therapy in metastatic disease following antiestrogen failure and as part of sequential adjuvant therapy following initial tamoxifen. It acts by blocking the activity of the enzyme aromatase, thereby resulting in reduced levels of circulating estrogen in postmenopausal women.

Category

Product Description

Exebenz 25 (Exemestane tablets) is an oral chemotherapeutic drug.

Indications and Usage

Exemestane is indicated for:

  • Adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy
  • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy

Dosage and Administration

Dosage and Administration

  • Recommended dose in breast cancer: One 25 mg tablet taken once daily after a meal4

Dosage Form and Strength

  • Supplied as tablets for oral use
  • Available in 25mg strength

Clinical Efficacy

  • Shows good efficacy and tolerability in treatment of patients with metastatic breast cancer who have failed one or more previous hormonal therapies
  • Slows disease progression and reduces tumor-related signs and symptoms in treatment of early and advanced breast cancer patients
  • Achieves response rates of 14% to 29% in patients with visceral metastases, who have historically proven difficult to treat
  • Increases breast conservation when used as neoadjuvant therapy
  • Significantly reduces the incidence of breast cancer in postmenopausal women at risk
  • More efficacious and has a better safety profile than tamoxifen

Adverse Reactions

  • The most common adverse events which occurs in women with early breast cancer (ATAC) includes hot flashes, fatigue, arthralgia, insomnia, headache, increased sweating and cardiac ischemic events
  • The most common adverse events which occurs in women with advanced breast cancer includes hot flashes, nausea, increased sweating, fatigue, and increased appetite

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to exemestane

Special Precautions

  • Patients should be closely monitored for changes in bone mineral density, as exemestane can cause reduction in bone mineral density
  • Perform a routine assessment of 25-hydroxy vitamin D levels prior to the start of exemestane treatment
  • Advise females of reproductive potential to use effective contraception as exemestane cause harm to fetus
  • Do not use exemestane in combination with strong CYP 3A4 inducers as concomitant use of strong CYP 3A4 inducers decreases exemestane exposure
    • It is not recommended for use in pregnant and breast feeding mothers
Exebenz 25 tablets - ADMAC Life Science