Details for: APO-LETROZOLE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02358514 | APO-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. APO-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 APO-LETROZOLE
beyond the standard 5 years of hormone
therapy is called "extended adjuvant therapy".
When it should not be used
APO-LETROZOLE should not be used in children and
adolescents under 18 years of age.
APO-LETROZOLE should not be used in hormonereceptor
negative disease.
Do not take APO-LETROZOLE if you:
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in APO-LETROZOLE;
- still have menstrual periods;
- are pregnant or breast-feeding, as APO-LETROZOLE may harm your baby.
What the medicinal ingredient is
Letrozole
What the non-medicinal ingredients are
APO-LETROZOLE also contains the following nonmedicinal ingredients needed to make the tablets: cellulose compounds (hydroxypropyl cellulose, hydroxypropyl methylcellulose and microcrystalline cellulose ), iron oxide yellow, lactose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide.
What dosage form it comes in
APO-LETROZOLE (letrozole) 2.5 mg tablets
APO-LETROZOLE is supplied as film-coated tablets.
The film-coated tablets are dark yellow and round
biconvex. They are engraved “APO” on one side, “LET”
over “2.5” on the other side.
Warnings and precautions
Serious Warnings and Precautions
APO-LETROZOLE should be used under the
supervision of a doctor experienced in the use of anticancer
drugs.
APO-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 APO-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 APO-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.
APO-LETROZOLE may reduce fertility in males.
If there is exposure to APO-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.
APO-LETROZOLE should not be used in children and
adolescents under 18 years of age.
Before you take APO-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. APO-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. APO-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:
APO-LETROZOLE tablets 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 overthe- counter medicines, vitamins or natural health products during your treatment with APO-LETROZOLE. This includes in particular:
- Tamoxifen.
- Other anti-estrogens or estrogen-containing therapies.
These substances may diminish the action of APO-LETROZOLE.
Proper use of this medication
Usual dose
The usual dosage is one tablet of APO-LETROZOLE to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take APO-LETROZOLE with or without food. It is best to take APO-LETROZOLE at about the same time every day.
Overdose
Missed Dose
If you forget to take a dose of APO-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 APO-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).
Side effects with frequency not known
- trigger finger, a condition in which your finger or thumb catches in a bent position.
If any of these affects you severely, tell your doctor.
If you notice any other side effects not listed in this
leaflet, please tell your doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| 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 APO-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 heat and moisture.
Keep this medicine out of the reach and sight of
children and pets.
Expiry date:
Do not take APO-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 Canadaby:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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
For more information, please contact your doctor,
pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared
for health professionals, can be obtained by contacting
DISpedia, Apotex's Drug Information Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario,
M9L 1T9.
Last revised: November 6, 2017