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Letrozole

LETROZOLE

Manufacturer: Accord Healthcare, Inc.

Score: 141.0

Quick Summary

Letrozole is an aromatase inhibitor used in the treatment of breast cancer. It is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer, extended adjuvant treatment of early breast cancer, and first- and second-line treatment of postmenopausal women with hormone receptor-positive or unknown advanced breast cancer. Letrozole works by inhibiting the aromatase enzyme, which is involved in the production of estrogen in the body. The recommended dose of letrozole is 2.5 mg once daily, without regard to meals. Important safety information includes warnings about bone effects, increases in cholesterol, and fatigue and dizziness. Contraindications include pregnancy and known hypersensitivity to the active substance or any of the excipients.

Key Clinical Findings and Indications

  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • Extended adjuvant treatment of early breast cancer
  • 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 when administered to a pregnant woman

Contraindications

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

Adverse Reactions

  • Hot flashes
  • Arthralgia
  • Fatigue
  • Hypercholesterolemia
  • Osteoporosis

Dosing Recommendations

General Guidance

No dose adjustment is required for patients with renal impairment if creatinine clearance is greater than or equal to 10 mL/min

Postmenopausal women with hormone receptor-positive early breast cancer

Adult Dose

2.5 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Letrozole can cause fetal harm when administered to a pregnant woman
  • Pregnancy testing is recommended prior to starting treatment with letrozole

Nursing Mothers

  • It is not known whether letrozole is excreted in human milk
  • Caution should be exercised when letrozole is administered to a nursing woman

Pediatric Use

  • The safety and effectiveness of letrozole in pediatric patients have not been established
  • Letrozole is not recommended for use in pediatric patients

Geriatric Use

  • No overall differences in safety or efficacy were observed between elderly patients and younger patients
  • Greater sensitivity of some older individuals cannot be ruled out

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