Details for: LETROZOLE
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02504472 | LETROZOLE | LETROZOLE | 2.5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- The adjuvant treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer;
- The extended adjuvant treatment of hormone receptor positive invasive early breast cancer in postmenopausal women who have received approximately 5 years of prior standard adjuvant tamoxifen therapy;
- The first-line therapy in postmenopausal women with advanced breast cancer; and
- The hormonal treatment of advanced metastatic breast cancer after relapse or disease progression in women with natural or artificially-induced postmenopausal endocrine status, who have previously been treated with antiestrogens.
What it does
Estrogen is a normally occurring female sex hormone that
stimulates normal breast tissue and the growth of some
types of breast cancer. LETROZOLE is an aromatase
inhibitor which acts by binding to aromatase, a substance
needed to make estrogen. As a result, the production of
estrogen and the growth of breast cancer are reduced.
What is adjuvant therapy:
Adjuvant therapy in breast cancer refers to treatment
following breast surgery (the primary or initial treatment) in
order to reduce the risk of recurrence. The purpose of
adjuvant therapy with LETROZOLE is to treat hormone
receptor-positive early breast cancer, after surgery, in
postmenopausal women to reduce the risk of recurrence.
What is extended adjuvant therapy:
The purpose of extended adjuvant therapy with
LETROZOLE is to treat hormone receptor-positive early
breast cancer in postmenopausal women who have received
approximately 5 years of prior standard adjuvant tamoxifen
therapy in order to prevent recurrence. Treating breast
cancer with LETROZOLE beyond the standard 5 years of
hormone therapy is called "extended adjuvant therapy".
When it should not be used
LETROZOLE should not be used in children and adolescents under 18 years of age. LETROZOLE should not be used in hormone-receptor negative disease
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in LETROZOLE ;
- still have menstrual periods;
- are pregnant or breast-feeding, as LETROZOLE may harm your baby.
What the medicinal ingredient is
Letrozole
What the non-medicinal ingredients are
LETROZOLE also contain the following nonmedicinal ingredients needed to make the tablets: cellulose compounds (microcrystalline cellulose and hypromellose), maize starch, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate, colloidal anhydrous silica, talc and titanium dioxide
What dosage form it comes in
LETROZOLE (letrozole) 2.5 mg tablets LETROZOLE are supplied as film-coated tablets. The filmcoated tablets are yellow, round, biconvex, film coated tablets marked with “LT” on one side and plain on other side. LETROZOLE are supplied in blister packs containing 30 tablets.
Warnings and precautions
Serious Warnings and Precautions
LETROZOLE should be used under the supervision
of a doctor experienced in the use of anti-cancer drugs.
LETROZOLE reduces blood estrogen levels which
may cause a reduction in bone mineral density and a
potential increase in bone loss (osteoporosis) and/or
bone fractures
The use of aromatase inhibitors, including LETROZOLE,
may increase the risk of cardiovascular events compared to
tamoxifen, such as heart attacks and stroke. Women at risk
of heart disease should be carefully monitored by their
doctor.
You should not use LETROZOLE if you may become
pregnant, or are pregnant. There is a potential risk of harm
to you and the fetus. There are reports of spontaneous
abortions and abnormalities in babies born to mothers who
took letrozole during pregnancy. If you have the potential
to become pregnant (this includes women who are
perimenopausal or who recently became postmenopausal),
you should discuss with your doctor about the need for
effective contraception. Use effective birth control during
treatment and for at least 20 days after stopping
LETROZOLE. Ask your doctor about options of for
effective birth control.
You should not use LETROZOLE if you are breastfeeding.
There is a potential risk of harm to breastfed babies.
LETROZOLE may reduce fertility in males.
If there is exposure to LETROZOLE during pregnancy,
you should contact your doctor immediately to discuss the
potential of harm to your fetus and potential risk for loss of
the pregnancy.
LETROZOLE should not be used in children and
adolescents under 18 years of age.
Before you take LETROZOLE:
Tell your doctor if you:
- have a serious kidney or serious liver disease
- are taking hormone replacement therapy;
- are taking other medication to treat your cancer;
- have a personal or family history of osteoporosis or have ever been diagnosed with low bone density or have a recent history of fractures (in order for your doctor to assess your bone health on a regular basis);
- have a personal or family history of high blood cholesterol or lipid levels. LETROZOLE may increase lipid levels;
- have or have had cardiovascular or heart disease including any of the following: heart attack, stroke or uncontrolled blood pressure. LETROZOLE may increase the risk of cardiovascular or heart diseases;
- have an intolerance to milk sugar (lactose);
- have pain in bones, or joints or muscles.
Your level of hormones may be checked by your doctor
before you take LETROZOLE and regularly during the first
6 months of treatment to confirm your menopausal status
(cessation of periods).
Driving a vehicle or using machinery:
LETROZOLE are unlikely to affect your ability to drive a
car or to use machinery. However, some patients may
occasionally feel tired, dizzy, sleepy or experience visual
disorders. If this happens, you should not drive or operate
any tools or machinery until you feel normal again.
Interactions with this medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the counter medicines, vitamins or natural health products during your treatment with LETROZOLE. This includes in particular:
- Tamoxifen.
- Other anti-estrogens or estrogen-containing therapies.
Proper use of this medication
Usual Dose:
The usual dosage is one tablet of LETROZOLE to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take LETROZOLE with or without food. It is best to take LETROZOLE at about the same time every day.
Overdose:
If overdosage is known or suspected, contact your doctor or the nearest poison control centre for advice immediately. Show the pack of tablets. Medical treatment may be necessary.
Missed Dose
If you forget to take a dose of LETROZOLE, don't worry, take the missed dose as soon as you remember. However, if it is almost time for the next dose (e.g. within 2 or 3 hours), skip the missed dose and go back to your regular dosage schedule. Do not take a double dose to make up for the one that you missed.
Side effects and what to do about them
As with all medicines, patients taking LETROZOLE may
experience side effects. Most side effects that have been
observed were mild to moderate and will generally
disappear after a few days to a few weeks of treatment.
Check with your doctor if the unwanted effects do not go
away during treatment or become bothersome.
Some side effects, such as hot flushes, hair loss or vaginal
bleeding may be due to the lack of estrogen in your body.
Very common side effects (they affect more than 10 in every 100 patients)
- increased level of cholesterol (hypercholesterolemia)
- hot flushes
- increased sweating
- night sweats
- fatigue (including weakness and malaise (generally feeling unwell))
- pain in bones and joints (arthralgia).
Common side effects (they affect between 1 to 10 in every 100 patients)
- headache
- rash
- dizziness, vertigo
- gastrointestinal disorders (such as, nausea, vomiting, indigestion, constipation, diarrhea)
- increase in or loss of appetite
- increased blood sugar (hyperglycaemia)
- urinary incontinence
- pain in muscles
- bone loss (osteoporosis)
- bone fractures
- depression
- weight increase
- anxiety
- insomnia
- hair loss
- vaginal bleeding
- dry skin
- raised blood pressure (hypertension)
- abdominal pain.
- back pain
- fall
- palpitations (rapid heart rate)
- joint stiffness (arthritis)
- chest pain
Uncommon side effects (they affect between 1 to 10 in every 1000 patients)
- nervous disorders (such as nervousness, irritability, drowsiness)
- pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
- reduced sense of touch (dysaesthesia)
- eye irritation
- itchy rash (urticaria), rapid swelling of face, lips, tongue, throat (angioedema)
- severe allergic reaction (anaphylactic reaction)
- vaginal disorders (such as discharge or dryness)
- breast pain
- fever
- thirst, taste disorder, dry mouth
- dryness of mucous membranes
- weight decrease
- urinary tract infection, increased frequency of urination
- cough
- abnormal liver function test results (blood test disorders).
- Increased bilirubin level (dark coloured urine)
- Jaundice (yellowish eyes and/or skin).
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Pain in the muscles, bones and joints; | ✔ | ||
| Joint stiffness; | ✔ | ||
| Persistent sad mood (i.e. depression) | ✔ | ||
| Uncommon | |||
| Tightness or feeling of heaviness in the chest or pain radiating from your chest to your arms or shoulders, neck, teeth or jaw, abdomen or back (signs of angina pectoris or heart attack); | ✔ | ||
| Numbness or weakness in arm or leg or any part of the body, loss of coordination, vision changes, sudden headache, nausea, loss of coordination, difficulty in speaking or breathing (signs of brain disease e.g. stroke) | ✔ | ||
| Swelling and redness along a vein which is extremely tender and possibly painful when touched (signs of inflammation of a vein due to a blood clot, e.g. thrombophlebitis); | ✔ | ||
| Difficulty breathing, chest pain, fainting rapid heart rate, bluish skin discoloration (signs of blood clot formation in the lung such as pulmonary embolism); | ✔ | ||
| Swelling of arms, hands, feet, ankles or other parts of the body (signs of oedema); | ✔ | ||
| Swelling mainly of the face and throat (signs of allergic reaction); | ✔ | ||
| Severe fever, chills or mouth ulcers due to infections (signs of low level of white blood cells); | ✔ | ||
| Blurred vision (sign of cataract). | ✔ | ||
| Yellow skin and eyes, nausea, loss of appetite, dark coloured urine (signs of hepatitis); | ✔ | ||
| Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder). | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking LETROZOLE, contact your doctor or pharmacist.
How to store
Store your tablets in a dry place at room temperature 15°C
to 30°C. Avoid places where the temperature may rise
above 30°C. Protect from moisture.
Keep this medicine out of the reach and sight of children and
pets.
Expiry date:
Do not take LETROZOLE after the expiry date which is
stated on the carton after EXP. The expiry date refers to the
last day of the month. Remember to take any unused
medication back to your pharmacist.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about LETROZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by contacting the sponsor Sanis Health Inc. at: 1-866-236-4076 or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: August 31, 2020