Letrozole
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]
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Overview
Letrozole is an aromatase inhibitor that is FDA approved for the {{{indicationType}}} of adjuvant treatment of early breast cancer, extended adjuvant treatment of early breast cancer, first and second-line treatment of advanced breast cancer. Common adverse reactions include hot flashes, arthralgia, flushing, asthenia, edema, arthralgia, headache, dizziness, hypercholesterolemia, sweating increased, and bone pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Adjuvant Treatment of Early Breast Cancer
Letrozole tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
The recommended dose of letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals.
Extended Adjuvant Treatment of Early Breast Cancer
Letrozole tablets, USP are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see Clinical Studies (14.2, 14.3)].
First and Second-Line Treatment of Advanced Breast Cancer
Letrozole tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. Letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Letrozole in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Letrozole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Letrozole in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Letrozole in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Letrozole in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Letrozole in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Letrozole in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Letrozole in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Letrozole during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Letrozole with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Letrozole with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Letrozole with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Letrozole with respect to specific gender populations.
Race
There is no FDA guidance on the use of Letrozole with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Letrozole in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Letrozole in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Letrozole in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Letrozole in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Letrozole in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Letrozole in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Letrozole in the drug label.
Pharmacology
There is limited information regarding Letrozole Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Letrozole in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Letrozole in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Letrozole in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Letrozole in the drug label.
How Supplied
Storage
There is limited information regarding Letrozole Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Letrozole in the drug label.
Precautions with Alcohol
- Alcohol-Letrozole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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