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Letrozole

LETROZOLE TABLETS

Manufacturer: Avet Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Letrozole is a nonsteroidal aromatase inhibitor used in the treatment of hormonally-responsive breast cancer. It is used as adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer, extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy, and first and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. The recommended dose is 2.5 mg once daily, with adjustments for patients with cirrhosis or severe hepatic impairment. Letrozole can cause fetal harm and is contraindicated in pregnancy, and has been associated with adverse reactions such as hot flashes, arthralgia, and osteoporosis.

Key Clinical Findings and Indications

  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy
  • First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer

Important Safety Information

Warning

Letrozole can cause fetal harm and is contraindicated in pregnancy

Contraindications

  • Pregnancy
  • Known hypersensitivity to the active substance or any of the excipients

Adverse Reactions

  • Hot flashes
  • Arthralgia
  • Osteoporosis
  • Hypercholesterolemia

Dosing Recommendations

General Guidance

For patients with cirrhosis or severe hepatic impairment, the dose should be reduced to 2.5 mg every other day

Hormone receptor positive early breast cancer

Adult Dose

2.5 mg once daily

Pediatric Dose

Not established

Advanced breast cancer

Adult Dose

2.5 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Letrozole can cause fetal harm and is contraindicated in pregnancy
  • Use of letrozole during pregnancy resulted in cases of spontaneous abortions and congenital birth defects

Nursing Mothers

  • It is not known whether letrozole is excreted in human milk

Pediatric Use

  • The safety and effectiveness of letrozole in pediatric patients have not been established

Geriatric Use

  • No overall differences in safety or efficacy were observed between elderly patients and younger patients
  • More adverse reactions were generally reported in elderly patients

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