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Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.
Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years.
Letrozole may also be used for purposes not listed in this medication guide.
You should not use letrozole if you are pregnant.
You should not use letrozole if you are allergic to it.
letrozole is for use only in women who can no longer get pregnant. Letrozole can harm an unborn baby. Do not use if you are pregnant. Use effective birth control if you are not past menopause. Keep using birth control for at least 3 weeks after your last dose of letrozole. Tell your doctor if you think you may be pregnant.
Tell your doctor if you have ever had:
liver disease (especially cirrhosis);
osteoporosis, osteopenia (low bone mineral density);
high cholesterol; or
if you also take tamoxifen.
You should not breast-feed while you are using letrozole and for at least 3 weeks after your last dose.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
You may take letrozole with or without food.
You will need frequent medical tests, and your bone mineral density may also need to be checked.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid driving or hazardous activity until you know how letrozole will affect you. Your reactions could be impaired.
This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Common side effects may include:
hot flashes, warmth or redness in your face or chest;
headache, dizziness, weakness;
bone pain, muscle or joint pain;
swelling, weight gain;
increased sweating; or
increased cholesterol in your blood.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Breast Cancer:
2.5 mg orally once a day
Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.
Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Usual Adult Dose for Breast Cancer -- Adjuvant:
2.5 mg orally once a day
Duration of therapy:
-Adjuvant and extended adjuvant settings: Optimal duration is unknown; discontinue therapy at relapse.
-Advanced disease: Until tumor progression is evident.
Uses:
-Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
-Extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy
-First-line treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or unknown locally advanced or metastatic breast cancer; second-line treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Other drugs may affect letrozole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Letrozole (www.drugs.com/mtm/letrozole.html).
Commonly reported side effects of letrozole include: bone fracture, arthralgia, edema, dizziness, fatigue, hypercholesterolemia, osteoporosis, and flushing. Other side effects include: myalgia. See below for a comprehensive list of adverse effects.
Applies to letrozole: oral tablet
Along with its needed effects, letrozole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking letrozole:
Less common
Rare
Incidence not known
Some side effects of letrozole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
Applies to letrozole: oral tablet
Very common (10% or more): Hot flash/flushing (50%), cardiovascular disease (14%), other cardiovascular event (13%)
Common (1% to 10%): Hypertension, chest pain, cardiac event (angina, coronary heart disease, myocardial ischemia, myocardial infarction), cardiac failure
Uncommon (0.1% to 1%): Palpitation, tachycardia, arterial thrombosis
Very common (10% or more): Nausea (17%), constipation (11%)
Common (1% to 10%): Vomiting, diarrhea, abdominal pain, dyspepsia
Uncommon (0.1% to 1%): Stomatitis, dry mouth
Very common (10% or more): Fatigue/lethargy/malaise/asthenia (34%), edema (18%), night sweats (15%)
Common (1% to 10%): Influenza, peripheral edema, pain, post-mastectomy lymphedema, thromboembolic event, viral infection
Uncommon (0.1% to 1%): Pyrexia, mucosal dryness, thirst
Frequency not reported: Peripheral thromboembolic event (venous thrombosis, thrombophlebitis, portal vein thrombosis, pulmonary embolism)
Very common (10% or more): Arthralgia/arthritis (25%), bone fracture (22%), musculoskeletal pain/back pain/arm pain/leg pain (22%), osteoporosis (15%), extremity/limb pain (10%)
Common (1% to 10%): Myalgia, bone pain, osteopenia, decreased lumbar spine bone mineral density
Postmarketing reports: Trigger finger
Very common (10% or more): Headache (20%), dizziness/lightheadedness (14%)
Common (1% to 10%): Somnolence, cerebrovascular events (transient ischemic attack, thrombotic or hemorrhagic stroke, hemiparesis development)
Uncommon (0.1% to 1%): Memory impairment, dysesthesia (hypesthesia/paresthesia), taste and thirst disturbance, carpal tunnel syndrome
Rare (less than 0.1%): Cerebrovascular infarction
Frequency not reported: Vertigo
Very common (10% or more): Dyspnea (18%), cough (13%)
Common (1% to 10%): Chest wall pain
Frequency not reported: Pleural effusion
Very common (10% or more): Increased sweating (24%)
Common (1% to 10%): Alopecia, dry skin, rash (erythematous, maculopapular, psoriasiform, vesicular), pruritus
Uncommon (0.1% to 1%): Urticaria
Very rare (less than 0.01%): Angioedema, toxic epidermal necrolysis, erythema multiforme
Uncommon (0.1% to 1%): Increased hepatic enzymes
Very rare (less than 0.01%): Hepatitis
Uncommon (0.1% to 1%): Leukopenia
Frequency not reported: Decreased lymphocyte count, thrombocytopenia
Common (1% to 10%): Cataract
Uncommon (0.1% to 1%): Eye irritation, blurred vision
Very common (10% or more): Hypercholesterolemia (53%), increased weight (13%)
Common (1% to 10%): Decreased weight, anorexia, increased appetite
Frequency not reported: Hypercalcemia
Very common (10% or more): Vaginal bleeding (13%)
Common (1% to 10%): Vaginal irritation, vaginal hemorrhage, vulvovaginal dryness, breast pain, urinary tract infection
Uncommon (0.1% to 1%): Increased urinary frequency, vaginal discharge
Very rare (less than 0.01%): Anaphylactic reactions
Common (1% to 10%): Secondary malignancy
Uncommon (0.1% to 1%): Endometrial hyperplasia/cancer, endometrial proliferation disorder, tumor pain
Rare (less than 0.1%): Other endometrial disorder
Frequency not reported: Stomatitis cancer pain
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Anxiety, nervousness, irritability
Common (1% to 10%): Renal disorders
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Letrozole (www.drugs.com/mtm/letrozole.html).
May 12, 2020
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