Details for: RIVA-LETROZOLE
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02398656 | RIVA-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
- with hormone receptor-positive invasive early breast cancer;
- The extended adjuvant treatment of hormone receptor positive 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. RIVA-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 RIVA-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 RIVA-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 RIVA-LETROZOLE beyond the standard 5 years of
hormone therapy is called "extended adjuvant therapy".
When it should not be used
RIVA-LETROZOLE should not be used in children and
adolescents under 18 years of age.
RIVA-LETROZOLE should not be used in hormone-receptor
negative disease.
Do not take RIVA-LETROZOLE if you:
- have ever had an unusual or allergic reaction to letrozole or any other ingredient in RIVA-LETROZOLE;
- still have menstrual periods;
- are pregnant or breast-feeding, as RIVA-LETROZOLE may harm your baby.
What the medicinal ingredient is
Letrozole
What the non-medicinal ingredients are
RIVA-LETROZOLE also contains the following non-medicinal ingredients needed to make the tablets: FD&C Yellow #6 aluminium lake, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium starch glycollate, talc, titanium dioxide and yellow iron oxide.
What dosage form it comes in
RIVA-LETROZOLE (letrozole) 2.5 mg tablets.
RIVA-LETROZOLE is supplied as film-coated tablets. The
film-coated tablets are yellow and round biconvex. They are
marked with “2.5” on one side and plain on the reverse side.
RIVA-LETROZOLE is supplied in blister packs containing 30
tablets.
Warnings and precautions
Serious Warnings and Precautions
RIVA-LETROZOLE should be used under the supervision of
a doctor experienced in the use of anti-cancer drugs.
RIVA-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 RIVA-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 RIVA-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
RIVA-LETROZOLE. Ask your doctor about options of for
effective birth control.
You should not use RIVA-LETROZOLE if you are
breastfeeding. There is a potential risk of harm to breastfed
babies.
RIVA-LETROZOLE may reduce fertility in males.
If there is exposure to RIVA-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.
RIVA-LETROZOLE should not be used in children and
adolescents under 18 years of age.
Before you take RIVA-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. RIVA-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. RIVA-LETROZOLE may increase the risk of cardiovascular or heart diseases;
- have pain in bones, or joints or muscles.
Your level of hormones may be checked by your doctor before
you take RIVA-LETROZOLE and regularly during the first 6
months of treatment to confirm your menopausal status
(cessation of periods).
Driving a vehicle or using machinery:
RIVA-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 over-the-counter medicines, vitamins or natural health products during your treatment with RIVA-LETROZOLE. This includes in particular:
- Tamoxifen.
- Other anti-estrogens or estrogen-containing therapies.
These substances may diminish the action of RIVA-LETROZOLE.
Proper use of this medication
Usual dose
The usual dosage is one tablet of RIVA-LETROZOLE to be taken once daily. The tablet should be swallowed whole with a small glass of water. You can take RIVA-LETROZOLE with or without food. It is best to take RIVA-LETROZOLE at about the same time every day.
Overdose
Missed Dose
If you forget to take a dose of RIVA-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 RIVA-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 colored 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 call your doctor or pharmacist |
|---|---|---|---|
| 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 RIVA-LETROZOLE, contact your doctor or pharmacist.
How to store
Store your tablets in a dry place at room temperature 15 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 RIVA-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 (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
This document plus the full product monograph, prepared for
health professionals can be found at www.labriva.com
or by contacting the sponsor, Laboratoire Riva Inc., at: 1-800-
363-7988.
This leaflet was prepared by
- Laboratoire Riva Inc.
660 Industriel Blvd
Blainville, Quebec
J7C 3V4
www.labriva.com
Last Revised: June 4, 2018